Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-01548 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| NRG-CC003 | Other Identifier | NRG Oncology | |
| NRG-CC003 | Other Identifier | DCP | |
| UG1CA189867 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Radiation Therapy Oncology Group | NETWORK |
Not provided
Not provided
Not provided
Not provided
This randomized phase II/III trial studies how well whole-brain radiation therapy works and compares it with or without hippocampal avoidance in treating patients with small cell lung cancer that is found in one lung, the tissues between the lungs, and nearby lymph nodes only (limited stage) or has spread outside of the lung in which it began or to other parts of the body (extensive stage). Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. The hippocampus is part of the brain that is important for memory. Avoiding the hippocampus during whole-brain radiation could decrease the chance of side effects on memory and thinking. It is not yet known whether giving whole-brain radiation therapy is more effective with or without hippocampal avoidance in treating patients with small cell lung cancer.
PRIMARY OBJECTIVES:
I. Determine whether the 12-month intracranial relapse rate following hippocampal avoidance (HA)-prophylactic cranial irradiation (PCI) is non-inferior compared to the rate following PCI for patients with small cell lung cancer (SCLC). (Randomized Phase II Component [Non-Inferiority]) II. Determine whether HA-PCI reduces the likelihood of 6-month deterioration from baseline in Hopkins Verbal Learning Test (HVLT)-Revised (R) delayed recall compared to PCI for patients with SCLC. (Phase III Component [Efficacy])
SECONDARY OBJECTIVES:
I. Compare time to cognitive failure, as measured by a battery of tests (HVLT-R, Controlled Oral Word Association (COWA) test, and Trail Making Test (TMT) parts A and B), after PCI versus HA-PCI in SCLC.
II. Compare time to cognitive failure as separately measured by each test (HVLT-R for Total Recall and Delayed Recognition, COWA test, and TMT parts A and B), after PCI versus HA-PCI for SCLC.
III. Compare patient-reported cognitive functioning and other quality of life domains (assessed by the European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire (QLQ)-Core [C]30 and BN20) between PCI versus HA-PCI for patients with SCLC.
IV. Compare overall survival after PCI versus HA-PCI for patients with SCLC.
V. Compare 12-month intracranial relapse rate (at completion of phase III) and time to intracranial relapse after PCI versus HA-PCI for patients with SCLC.
VI. Evaluate adverse events according to Common Terminology Criteria for Adverse Events (CTCAE) criteria.
VII. Correlate changes in health-related quality of life (HRQOL) domains with changes in cognitive testing outcomes following PCI versus HA-PCI for patients with SCLC.
VIII. Assess cost-effectiveness of HA-PCI (intensity modulated radiation therapy [IMRT]) and PCI (3-dimensional conformal radiation therapy [3DCRT]) using the EuroQual (EQ)-5-Dimensions (5D)-5L.
IX. Correlate miRNA signatures with cognitive failure in SCLC patients who received PCI and HA-PCI.
X. Evaluate Apolipoprotein E (APOE) genotyping as potential predictor of neurocognitive decline, hippocampal atrophy after brain irradiation and/or differential benefit from hippocampal avoidance.
XI. Evaluate baseline MR imaging biomarkers of white matter injury and hippocampal volumetry as potential predictors of cognitive decline and differential benefit from HA-PCI as compared to PCI.
TERTIARY OBJECTIVES:
I. Collect serum, whole blood, and urine for future translational research analyses.
II. Evaluate baseline magnetic resonance (MR) imaging biomarkers of white matter injury and hippocampal volumetry as potential predictors of cognitive decline and differential benefit from HA-PCI as compared to PCI.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo PCI using 3DCRT daily for 2 weeks.
ARM II: Patients undergo PCI with HA using IMRT daily for 2 weeks.
After completion of study treatment, patients are followed every 3 months for 1 year, then every 6 months until 3 years and then annually until death.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCI using 3DCRT | Active Comparator | Prophylactic cranial irradiation (PCI) using three-dimensional conformal radiation therapy (3DCRT) for 2 weeks, 5 fractions/week. |
|
| PCI with HA using IMRT | Experimental | PCI with hippocampal avoidance (HA) using intensity-modulated radiation therapy (IMRT) for 2 weeks, 5 fractions/week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Three-Dimensional Conformal Radiation Therapy | Radiation | daily fractions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Deterioration in HVLT-R Delayed Recall Score at Six Months (Phase III) | The HVLT-R delayed recall test assesses verbal learning and memory. The test involves memorizing a list of 12 nouns for 3 consecutive trials to recall after a 20-minute delay. The score is the sum of the number of words correctly recalled and ranges from 0 to 36, with a higher score indicating better functioning. Deterioration is defined a decrease from baseline of at least 3 points. | Baseline and six months |
| Number of Participants With Intracranial Relapse at 12 Months (Phase II) | Intracranial relapse, defined as the development of a new brain metastasis as documented on brain MRI with contrast or head CT with contrast. | From baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Neurocognitive Failure (Phase III) | Neurocognitive failure is defined as the first instance of neurocognitive decline in any of six assessments, as determined my reliable change index: Hopkins Verbal Learning Test-Revised (HVLT-R) Total Recall, HVLT-R Delayed Recall, HVLT-R Delayed Recognition, Trail Making Test (TMT) part A, TMT part B, and Controlled Oral Word Association (COWA). Failure time is defined as time from randomization to failure, death (competing event), or last follow-up (censored). Neurocognitive failure rates are estimated using the cumulative incidence method. The distributions of failure times are compared, which is reported in the statistical analysis results. Six-month rates are reported here. Analysis occurred after all patients had been on study for at least six months. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Deterioration in HVLT-R Delayed Recall Score at Six Months (Phase III) by Sex | NIH-required analysis. The HVLT-R delayed recall test assesses verbal learning and memory. The test involves memorizing a list of 12 nouns for 3 consecutive trials to recall after a 20-minute delay. The score is the sum of the number of words correctly recalled and ranges from 0 to 36, with a higher score indicating better functioning. Deterioration is defined a decrease from baseline of at least 3 points. |
Inclusion Criteria [prior to Step 1 registration]:
Histologic proof or unequivocal cytologic proof (fine needle aspiration, biopsy or two positive sputa) of SCLC within 250 days prior to Step 1 registration
Patients must have received chemotherapy and be registered to Step 1 registration no earlier than 7 days and no later than 56 days after completing chemotherapy. Note:
Patients must have a gadolinium contrast-enhanced three-dimensional (3D), spoiled gradient (SPGR), magnetization-prepared rapid gradient echo (MP-RAGE), or turbo field echo (TFE) MRI scan. To yield acceptable image quality, the gadolinium contrast-enhanced three-dimensional SPGR, MP-RAGE or TFE axial MRI scan must use the smallest possible axial slice thickness not exceeding 1.5 mm.
Prior to chemotherapy +/- thoracic radiotherapy, patients must be defined as limited-stage or extensive-stage SCLC after clinical staging evaluation involving the following:
After chemotherapy, patients must be restaged prior to Step 1 registration using the same diagnostic work-up as required pre-chemotherapy. Repeat PET/CT or bone scan is not required. Patients must have:
History/physical examination within 30 days of Step 1 registration;
No CNS metastases (Repeat MRI required) within 56 days prior to Step 1 registration;
No progression in any site;
Radiographic partial or complete response to chemotherapy in at least one disease site within 56 days prior to Step 1 registration.
Zubrod performance status 0-2 within 30 days prior to Step 1 registration.
Women of childbearing potential must have a negative qualitative serum pregnancy test =< 14 days prior to Step 1 registration.
Patients who are primary English or French speakers are eligible
Patients must sign a study-specific informed consent prior to study entry
Inclusion Criteria [prior to Step 2 registration]:
Exclusion Criteria:
Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields
Radiographic evidence of central nervous system (CNS) metastases
Radiographic evidence of hydrocephalus or other architectural distortion of the ventricular system, including placement of external ventricular drain or ventriculoperitoneal shunt
Planned concurrent chemotherapy during PCI
Concomitant invasive malignancy or invasive malignancy within the past five years other than non-melanomatous skin cancer; history of in situ carcinoma (e.g. ductal carcinoma in situ of breast, in situ carcinoma of the cervix, vulva or larynx) is permitted
Contraindication to MR imaging, such as implanted metal devices or foreign bodies or severe claustrophobia
Severe, active comorbidity, defined as follows:
Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
Transmural myocardial infarction within the last 6 months
Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
Uncontrolled, clinically significant cardiac arrhythmias
HIV positive with CD4 count < 200 cells/microliter;
Pregnant or lactating women or women of childbearing potential and male participants who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the radiation treatment involved in this study may be significantly teratogenic.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Vinai Gondi | NRG Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | Birmingham | Alabama | 35233 | United States | ||
| Lewis and Faye Manderson Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40789106 | Derived | Gondi V, Pugh SL, Mehta MP, Wefel JS, Tome WA, Sun AY, Grecula J, Redmond KJ, Fogh S, Gaspar L, Konski A, Bovi J, Robinson CG, Corn B, Videtic GM, Lok BH, Yoon HA, Heinzerling JH, DeNittis AS, McGarry RC, Devisetty K, Kundapur V, Wu AJ, McCarron EC, Thibault I, Simon EL, Baschnagel AM, Narayan S, Pollock J, Paulus R, Kachnic LA; NRG Oncology. Hippocampal Avoidance During Prophylactic Cranial Irradiation for Patients With Small Cell Lung Cancer: Randomized Phase II/III Trial NRG-CC003. J Clin Oncol. 2025 Nov 10;43(32):3516-3525. doi: 10.1200/JCO-25-00221. Epub 2025 Aug 11. | |
| 34632876 |
Not provided
Not provided
NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
Not provided
Not provided
Not provided
Patients were screened in order to determine whether their neurocognitive functioning was healthy enough to participate. This was defined as a score of 2 or higher on the Delayed Recall subscale of the Hopkins Verbal Learning Test (HVLT). HVLT testing was done after initial enrollment, but prior to randomization. Of 418 participants screened, 393 were randomized.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | PCI Using 3DCRT | Prophylactic cranial irradiation (PCI) using three-dimensional conformal radiation therapy (3DCRT) for 2 weeks, 5 fractions/week. |
| FG001 | PCI With HA Using IMRT |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 1, 2022 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Intensity-Modulated Radiation Therapy | Radiation | daily fractions |
|
|
| Randomization to date of failure, death, or last known follow-up whichever occurred first. Maximum follow-up at time of analysis was 7.2 years. |
| Number of Participants With Deterioration in HVLT-R Total Recall Score (Phase III) | The HVLT-R Total Recall score assesses verbal learning and memory. The test involves memorizing a list of 12 nouns for 3 consecutive trials. Raw score is the sum of the number of targets correctly recalled, ranging from 0 to 36. Higher score indicates better functioning. Deterioration is defined a decrease from baseline of at least 5 points. | Baseline, 3, 6, 12 months. |
| Number of Participants With Deterioration in HVLT-R Total Recall Score (Phase III) | he HVLT-R Total Recall score assesses verbal learning and memory. The test involves memorizing a list of 12 nouns for 3 consecutive trials. Raw score is the sum of the number of targets correctly recalled, ranging from 0 to 36. Higher score indicates better functioning. Deterioration is defined a decrease from baseline of at least 5 points. | Baseline,18, 24 months. |
| Number of Participants With Deterioration in HVLT-R Delayed Recall Score (Phase III) | The HVLT-R Delayed Recall test assesses verbal learning and memory. After memorizing a list of 12 nouns for 3 consecutive trials, this test requires recalling the 12 targets after a 20-minute delay. Raw scores are sum of the number of targets correctly recalled. The score ranges from 0 to 12. A higher score indicates better functioning. Deterioration is defined a decrease from baseline of at least 3 points. Six-month results are reported as the primary endpoint. | Baseline, 3, 12 months. |
| Number of Participants With Deterioration in HVLT-R Delayed Recall Score (Phase III) | The HVLT-R Delayed Recall test assesses verbal learning and memory. After memorizing a list of 12 nouns for 3 consecutive trials, this test requires recalling the 12 targets after a 20-minute delay. Raw scores are sum of the number of targets correctly recalled. The score ranges from 0 to 12. A higher score indicates better functioning. Deterioration is defined a decrease from baseline of at least 3 points. | Baseline, 18, 24 months. |
| Number of Participants With Deterioration in HVLT-R Delayed Recognition Score (Phase III) | The HVLT-R Delayed Recognition assesses verbal learning and memory. After memorizing a list of 12 nouns for 3 consecutive trials and recalling the 12 targets after a 20-minute delay, the test involves then identifying the 12 targets from a list of semantically related or unrelated items (delayed recognition). Raw scores are the sum of targets incorrectly identified subtracted from the sum of the number of targets correctly identified. The score ranges from -12 to 12 for recognition. A higher score indicates better functioning. Deterioration is defined a decrease from baseline of at least 2 points. | Baseline, 3, 6, 12 months. |
| Number of Participants With Deterioration in HVLT-R Delayed Recognition Score (Phase III) | The HVLT-R Delayed Recognition assesses verbal learning and memory. After memorizing a list of 12 nouns for 3 consecutive trials and recalling the 12 targets after a 20-minute delay, the test involves then identifying the 12 targets from a list of semantically related or unrelated items (delayed recognition). Raw scores are the sum of targets incorrectly identified subtracted from the sum of the number of targets correctly identified. The score ranges from -12 to 12 for recognition. A higher score indicates better functioning. Deterioration is defined a decrease from baseline of at least 2 points. | Baseline, 18, 24 months. |
| Number of Participants With Deterioration in Trail Making Test (TMT) Part A (Phase III) | The TMT is a neuropsychological test of visual attention and task switching that can provide information about visual search speed, scanning, speed of processing, mental flexibility, and executive functioning. Subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. There are two parts to the test: in the first (Part A, reported here), the targets are all numbers (1, 2, 3, etc.) and the test taker needs to connect them in sequential order. The score is the amount of time, in seconds, that it takes the patient to complete the maze. The range for Part A is 0 to 180 (3 minutes). Lower scores indicate better functioning. Deterioration is defined an increase from baseline of at least 12 seconds. | Baseline, 3, 6, 12 months. |
| Number of Participants With Deterioration in Trail Making Test (TMT) Part A (Phase III) | The TMT is a neuropsychological test of visual attention and task switching that can provide information about visual search speed, scanning, speed of processing, mental flexibility, and executive functioning. Subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. There are two parts to the test: in the first (Part A, reported here), the targets are all numbers (1, 2, 3, etc.) and the test taker needs to connect them in sequential order. The score is the amount of time, in seconds, that it takes the patient to complete the maze. The range for Part A is 0 to 180 (3 minutes). Lower scores indicate better functioning. Deterioration is defined an increase from baseline of at least 12 seconds. | Baseline, 18, 24 months. |
| Number of Participants With Deterioration in TMT Part B Score (Phase III) | The TMT is a neuropsychological test of visual attention and task switching that can provide information about visual search speed, scanning, speed of processing, mental flexibility, and executive functioning. Subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. There are two parts to the test: in the second part (Part B, reported here), the subject alternates between numbers and letters (1, A, 2, B, etc.). The score is the amount of time, in seconds, that it takes the patient to complete the maze. The score range for Part B is 0 to 300 (5 minutes). Lower scores indicate better functioning. Deterioration is defined an increase from baseline of at least 26 seconds. | Baseline, 3, 6, 12 months. |
| Number of Participants With Deterioration in TMT Part B Score (Phase III) | The TMT is a neuropsychological test of visual attention and task switching that can provide information about visual search speed, scanning, speed of processing, mental flexibility, and executive functioning. Subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. There are two parts to the test: in the second part (Part B, reported here), the subject alternates between numbers and letters (1, A, 2, B, etc.). The score is the amount of time, in seconds, that it takes the patient to complete the maze. The score range for Part B is 0 to 300 (5 minutes). Lower scores indicate better functioning. Deterioration is defined an increase from baseline of at least 26 seconds. If reporting a score on a scale, please include the unabbreviated scale title, the minimum and maximum values, and whether higher scores mean a better or worse outcome. | Baseline, 18, 24 months. |
| Number of Participants With Deterioration in Controlled Oral Word Association (COWA) Score (Phase III) | The COWA is a verbal fluency test that measures spontaneous production of words belonging to the same category or beginning with some designated letter. Patients are given 1 minute to name as many words as possible beginning with the designated letter. The procedure is then repeated for the remaining two letters. Two alternate forms of the COWA are employed to minimize practice effects. The score is the sum of the correct responses with a range of 0 to infinity. A higher score indicates better functioning. Deterioration is defined an increase from baseline of at least 12 words. | Baseline, 3, 6, 12 months. |
| Number of Participants With Deterioration in Controlled Oral Word Association (COWA) Score (Phase III) | The COWA is a verbal fluency test that measures spontaneous production of words belonging to the same category or beginning with some designated letter. Patients are given 1 minute to name as many words as possible beginning with the designated letter. The procedure is then repeated for the remaining two letters. Two alternate forms of the COWA are employed to minimize practice effects. The score is the sum of the correct responses with a range of 0 to infinity. A higher score indicates better functioning. Deterioration is defined an increase from baseline of at least 12 words. | Baseline,18, 24 months. |
| Number of Participants by Highest Grade Adverse Event Reported (Phase III) | Common Terminology Criteria for Adverse Events (version 5) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. | From start of treatment to last known follow-up . Maximum follow-up time was 7.2 years. |
| Number of Participants With Deterioration in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (QLQ-C30) Global Health Status (Phase III) | The QLQ-C30 is a 30-item self-report questionnaire used to assess the health-related quality of life (QOL) of cancer patients participating in international clinical trials. Global Health Status is considered a measure of overall quality of life and is calculated from two questions whose raw scores are averaged and then transformed to a range of 0 (worst) to 100 (best). Deterioration is defined a reduction of 10% from baseline. | Baseline, 3, 6, 12 months. |
| Number of Participants With Deterioration in EORTC QLQ-C30 Global Health Status (Phase III) | The QLQ-C30 is a 30-item self-report questionnaire used to assess the health-related quality of life (QOL) of cancer patients participating in international clinical trials. Global Health Status is considered a measure of overall quality of life and is calculated from two questions whose raw scores are averaged and then transformed to a range of 0 (worst) to 100 (best). Deterioration is defined a reduction of 10% from baseline. | Baseline,18, 24 months. |
| Number of Participants With Deterioration in EORTC QLQ-C30 Physical Functioning Score (Phase III) | The EORTC QLQ-C30 is a 30-item self-report questionnaire used to assess the health-related quality of life of cancer patients participating in international clinical trials. A functional scale raw score is transformed to a range of 0 (worst) to 100 (best) in which a high score represents a healthy level of functioning. Deterioration is defined a reduction of 10% from baseline. | Baseline, 3, 6, 12 months. |
| Number of Participants With Deterioration in EORTC QLQ-C30 Physical Functioning Score (Phase III) | The EORTC QLQ-C30 is a 30-item self-report questionnaire used to assess the health-related quality of life of cancer patients participating in international clinical trials. A functional scale raw score is transformed to a range of 0 (worst) to 100 (best) in which a high score represents a healthy level of functioning. Deterioration is defined a reduction of 10% from baseline. | Baseline,18, 24 months. |
| Number of Participants With Deterioration in EORTC QLQ-C30 Role Functioning Score (Phase III) | The EORTC QLQ-C30 is a 30-item self-report questionnaire used to assess the health-related quality of life (QOL) of cancer patients participating in international clinical trials. A functional scale raw score is transformed to a range of 0 (worst) to 100 (best) in which a high score represents a healthy level of functioning. Deterioration is defined a reduction of 10% from baseline. | Baseline, 3, 6, 12 months. |
| Number of Participants With Deterioration in EORTC QLQ-C30 Role Functioning Score (Phase III) | The EORTC QLQ-C30 is a 30-item self-report questionnaire used to assess the health-related quality of life (QOL) of cancer patients participating in international clinical trials. A functional scale raw score is transformed to a range of 0 (worst) to 100 (best) in which a high score represents a healthy level of functioning. Deterioration is defined a reduction of 10% from baseline. | Baseline,18, 24 months. |
| Number of Participants With Deterioration in EORTC QLQ-C30 Emotional Functioning Score (Phase III) | The EORTC QLQ-C30 is a 30-item self-report questionnaire used to assess the health-related quality of life of cancer patients participating in international clinical trials. A functional scale raw score is transformed to a range of 0 (worst) to 100 (best) in which a high score represents a healthy level of functioning. Deterioration is defined a reduction of 10% from baseline. | Baseline, 3, 6, 12 months. |
| Number of Participants With Deterioration in EORTC QLQ-C30 Emotional Functioning Score (Phase III) | The EORTC QLQ-C30 is a 30-item self-report questionnaire used to assess the health-related quality of life of cancer patients participating in international clinical trials. A functional scale raw score is transformed to a range of 0 (worst) to 100 (best) in which a high score represents a healthy level of functioning. Deterioration is defined a reduction of 10% from baseline. | Baseline,18, 24 months. |
| Number of Participants With Deterioration in EORTC QLQ-C30 Social Functioning Score (Phase III) | The EORTC QLQ-C30 is a 30-item self-report questionnaire used to assess the health-related quality of life (QOL) of cancer patients participating in international clinical trials. A functional scale raw score is transformed to a range of 0 (worst) to 100 (best) in which a high score represents a healthy level of functioning. Deterioration is defined a reduction of 10% from baseline. | Baseline, 3, 6, 12 months. |
| Number of Participants With Deterioration in EORTC QLQ-C30 Social Functioning Score (Phase III) | The EORTC QLQ-C30 is a 30-item self-report questionnaire used to assess the health-related quality of life (QOL) of cancer patients participating in international clinical trials. A functional scale raw score is transformed to a range of 0 (worst) to 100 (best) in which a high score represents a healthy level of functioning. Deterioration is defined a reduction of 10% from baseline. | Baseline,18, 24 months. |
| Number of Participants With Deterioration in EORTC QLQ-C30 Cognitive Functioning Score (Phase III) | The EORTC QLQ-C30 is a 30-item self-report questionnaire used to assess the health-related quality of life (QOL) of cancer patients participating in international clinical trials. A functional scale raw score is transformed to a range of 0 (worst) to 100 (best) in which a high score represents a healthy level of functioning. Deterioration is defined a reduction of 10% from baseline. | Baseline, 3, 6, 12 months. |
| Number of Participants With Deterioration in EORTC QLQ-C30 Cognitive Functioning Score (Phase III) | The EORTC QLQ-C30 is a 30-item self-report questionnaire used to assess the health-related quality of life (QOL) of cancer patients participating in international clinical trials. A functional scale raw score is transformed to a range of 0 (worst) to 100 (best) in which a high score represents a healthy level of functioning. Deterioration is defined a reduction of 10% from baseline. | Baseline,18, 24 months. |
| Number of Participants With Deterioration in EORTC Quality of Life Questionnaire BN-20 (QLQ-BN20) Motor Dysfunction Score (Phase III) | The EORTC QLQ-BN20 is a 20-item self-report questionnaire supplement to the QLQ-C30 for patients used to assess the health-related quality of life of brain cancer patients. A symptom scale raw score is transformed to a range of 0 (best) to 100 (worst) in which a high score represents a high level of symptomatology/problems. For patients with a baseline score of 0, a follow-up score of ≥ 10 is considered as a deterioration. Otherwise, a 10% increase is considered as a deterioration. | Baseline, 3, 6, 12 months. |
| Number of Participants With Deterioration in EORTC QLQ-BN20 Motor Dysfunction Score (Phase III) | The EORTC QLQ-BN20 is a 20-item self-report questionnaire supplement to the QLQ-C30 for patients used to assess the health-related quality of life of brain cancer patients. A symptom scale raw score is transformed to a range of 0 (best) to 100 (worst) in which a high score represents a high level of symptomatology/problems. For patients with a baseline score of 0, a follow-up score of ≥ 10 is considered as a deterioration. Otherwise, a 10% increase is considered as a deterioration. | Baseline,18, 24 months. |
| Number of Participants With Deterioration in EORTC QLQ-BN20 Communication Deficit Score (Phase III) | The QLQ-BN20 is a 20-item self-report questionnaire supplement to the QLQ-C30 for patients used to assess the health-related quality of life of brain cancer patients. A symptom scale raw score is transformed to a range of 0 (best) to 100 (worst) in which a high score represents a high level of symptomatology/problems. For patients with a baseline score of 0, a follow-up score of ≥ 10 is considered as a deterioration. Otherwise, a 10% increase is considered as a deterioration. | Baseline, 3, 6, 12 months. |
| Number of Participants With Deterioration in EORTC QLQ-BN20 Communication Deficit Score (Phase III) | The QLQ-BN20 is a 20-item self-report questionnaire supplement to the QLQ-C30 for patients used to assess the health-related quality of life of brain cancer patients. A symptom scale raw score is transformed to a range of 0 (best) to 100 (worst) in which a high score represents a high level of symptomatology/problems. For patients with a baseline score of 0, a follow-up score of ≥ 10 is considered as a deterioration. Otherwise, a 10% increase is considered as a deterioration. | Baseline,18, 24 months. |
| Correlation of Quality of Life and Neurocognitive Function (NCF) Measures at 6 Months | The Pearson correlation coefficient was calculated for EORTC QLQ-C30 (physical, role, emotional, cognitive, and social functioning domains and global health status) and QLQ-BN20 (motor dysfunction and communication deficit) versus the standardized neurocognitive function (HVLT-R total recall, HVLT-R delayed recall, HVLT-R delayed recognition, COWA, TMT parts A and B) and the Clinical Trial Battery Composite (CTB Comp) score (mean of the z-scores for the six NCF scores) for all patients, treatment arms combined. The Pearson correlation coefficient is computed for each pair of measurements, resulting in 48 correlation coefficients. Possible values range from -1 (negatively correlated) to 1(positively correlated), with 0 indicating no correlation. A correlation with a value in range -0.35 to 0.35 is considered weak and is indicated by "0" in the table. Because of the large number of comparisons, only individual correlation coefficients outside that range are listed here. | 6 months |
| Incremental Cost-per Quality-adjusted Life Year (QALY) (Cost-effectiveness as Measured by the EQ-5D (Phase III) | The incremental cost per quality-adjusted life year (QALY) ratio will be calculated as total cost of the PCI with HA using IMRT arm (Arm 2) minus total cost of the PCI using 3DCRT arm (Arm 1), divided by the quality adjusted survival of the Arm 1 patients minus the quality adjusted survival of Arm 2 patients. | Baseline to two years |
| Overall Survival (Phase III) | Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. Analysis occurred after all patients had been on study for at least 8 months. | From the date of randomization to the date of death or last follow-up. Maximum follow-up time at time of analysis was 7.2 years. |
| Intracranial Relapse Rate (Phase III) | Intracranial relapse is defined as the development of a new brain metastasis as documented on brain MRI with contrast or head CT with contrast. Time to intracranial relapse is defined as time from randomization to the date of first intracranial relapse, last known follow-up (censored), or death without intracranial relapse (competing risk), whichever occurred first. Intracranial relapse rates are estimated using the cumulative incidence method. The distributions of intracranial relapse times are compared between the arms, which is reported in the statistical analysis results. One-year rates are provided here. Analysis occurred at time of the phase III primary analysis. | From date of randomization to date of intracranial relapse, death, or last known follow-up, whichever occurred first. Maximum follow-up at time of analysis was 7.2 years. |
| White Matter Injury and Hippocampal Volume on Neurocognitive Function (Phase III) | Pearson correlation coefficients will be used to assess the effect of hippocampal volume and FLAIR volume change on baseline neurocognitive function, as measured by the HVLT-R, COWA, and TMT, separately for each arm. | Baseline to 6 months |
| Baseline and six months |
| Number of Participants With Deterioration in HVLT-R Delayed Recall Score at Six Months (Phase III) by Ethnicity | NIH-required analysis. The HVLT-R delayed recall test assesses verbal learning and memory. The test involves memorizing a list of 12 nouns for 3 consecutive trials to recall after a 20-minute delay. The score is the sum of the number of words correctly recalled and ranges from 0 to 36, with a higher score indicating better functioning. Deterioration is defined a decrease from baseline of at least 3 points. | Baseline and six months |
| Number of Participants With Deterioration in HVLT-R Delayed Recall Score at Six Months (Phase III) by Race | NIH-required analysis. The HVLT-R delayed recall test assesses verbal learning and memory. The test involves memorizing a list of 12 nouns for 3 consecutive trials to recall after a 20-minute delay. The score is the sum of the number of words correctly recalled and ranges from 0 to 36, with a higher score indicating better functioning. Deterioration is defined a decrease from baseline of at least 3 points. | Baseline and six months |
| Tuscaloosa |
| Alabama |
| 35401 |
| United States |
| Banner University Medical Center - Tucson | Tucson | Arizona | 85719 | United States |
| Marin General Hospital | Greenbrae | California | 94904 | United States |
| Los Angeles General Medical Center | Los Angeles | California | 90033 | United States |
| USC / Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
| Mercy Cancer Center | Merced | California | 95340 | United States |
| Kaiser Permanente Oakland-Broadway | Oakland | California | 94611 | United States |
| Saint Joseph Hospital - Orange | Orange | California | 92868 | United States |
| Kaiser Permanente-Rancho Cordova Cancer Center | Rancho Cordova | California | 95670 | United States |
| Sutter Cancer Centers Radiation Oncology Services-Roseville | Roseville | California | 95661 | United States |
| The Permanente Medical Group-Roseville Radiation Oncology | Roseville | California | 95678 | United States |
| Sutter Medical Center Sacramento | Sacramento | California | 95816 | United States |
| University of California Davis Comprehensive Cancer Center | Sacramento | California | 95817 | United States |
| California Pacific Medical Center-Pacific Campus | San Francisco | California | 94115 | United States |
| Kaiser Permanente Medical Center - Santa Clara | Santa Clara | California | 95051 | United States |
| Gene Upshaw Memorial Tahoe Forest Cancer Center | Truckee | California | 96161 | United States |
| Sutter Solano Medical Center/Cancer Center | Vallejo | California | 94589 | United States |
| Swedish Medical Center | Englewood | Colorado | 80113 | United States |
| Poudre Valley Hospital | Fort Collins | Colorado | 80524 | United States |
| Hartford HealthCare - Saint Vincent's Medical Center | Bridgeport | Connecticut | 06606 | United States |
| Yale University | New Haven | Connecticut | 06520 | United States |
| Helen F Graham Cancer Center | Newark | Delaware | 19713 | United States |
| Christiana Care Health System-Christiana Hospital | Newark | Delaware | 19718 | United States |
| Boca Raton Regional Hospital | Boca Raton | Florida | 33486 | United States |
| UM Sylvester Comprehensive Cancer Center at Coral Gables | Coral Gables | Florida | 33146 | United States |
| Broward Health Medical Center | Fort Lauderdale | Florida | 33316 | United States |
| University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida | 33136 | United States |
| Miami Cancer Institute | Miami | Florida | 33176 | United States |
| Orlando Health Cancer Institute | Orlando | Florida | 32806 | United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| Grady Health System | Atlanta | Georgia | 30303 | United States |
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | United States |
| Piedmont Hospital | Atlanta | Georgia | 30309 | United States |
| Emory University Hospital/Winship Cancer Institute | Atlanta | Georgia | 30322 | United States |
| Northside Hospital | Atlanta | Georgia | 30342 | United States |
| Northside Hospital-Forsyth | Cumming | Georgia | 30041 | United States |
| Memorial Health University Medical Center | Savannah | Georgia | 31404 | United States |
| Lewis Cancer and Research Pavilion at Saint Joseph's/Candler | Savannah | Georgia | 31405 | United States |
| Queen's Medical Center | Honolulu | Hawaii | 96813 | United States |
| The Cancer Center of Hawaii-Liliha | Honolulu | Hawaii | 96817 | United States |
| The Cancer Center of Hawaii-Pali Momi | ‘Aiea | Hawaii | 96701 | United States |
| Saint Alphonsus Cancer Care Center-Boise | Boise | Idaho | 83706 | United States |
| Saint Luke's Cancer Institute - Boise | Boise | Idaho | 83712 | United States |
| Saint Alphonsus Cancer Care Center-Caldwell | Caldwell | Idaho | 83605 | United States |
| Saint Luke's Cancer Institute - Meridian | Meridian | Idaho | 83642 | United States |
| Saint Alphonsus Cancer Care Center-Nampa | Nampa | Idaho | 83687 | United States |
| Saint Luke's Cancer Institute - Nampa | Nampa | Idaho | 83687 | United States |
| Saint Luke's Cancer Institute - Twin Falls | Twin Falls | Idaho | 83301 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| John H Stroger Jr Hospital of Cook County | Chicago | Illinois | 60612 | United States |
| Rush MD Anderson Cancer Center | Chicago | Illinois | 60612 | United States |
| Decatur Memorial Hospital | Decatur | Illinois | 62526 | United States |
| Crossroads Cancer Center | Effingham | Illinois | 62401 | United States |
| Northwestern Medicine Cancer Center Delnor | Geneva | Illinois | 60134 | United States |
| Edward Hines Jr VA Hospital | Hines | Illinois | 60141 | United States |
| Condell Memorial Hospital | Libertyville | Illinois | 60048 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Illinois CancerCare-Peoria | Peoria | Illinois | 61615 | United States |
| Methodist Medical Center of Illinois | Peoria | Illinois | 61636 | United States |
| OSF Saint Francis Medical Center | Peoria | Illinois | 61637 | United States |
| Springfield Memorial Hospital | Springfield | Illinois | 62781 | United States |
| Carle Cancer Center | Urbana | Illinois | 61801 | United States |
| Northwestern Medicine Cancer Center Warrenville | Warrenville | Illinois | 60555 | United States |
| Ascension Saint Vincent Anderson | Anderson | Indiana | 46016 | United States |
| Parkview Hospital Randallia | Fort Wayne | Indiana | 46805 | United States |
| Parkview Regional Medical Center | Fort Wayne | Indiana | 46845 | United States |
| Goshen Center for Cancer Care | Goshen | Indiana | 46526 | United States |
| IU Health Ball Memorial Hospital | Muncie | Indiana | 47303 | United States |
| Saint Luke's Hospital | Cedar Rapids | Iowa | 52402 | United States |
| Mercy Hospital | Cedar Rapids | Iowa | 52403 | United States |
| Iowa Methodist Medical Center | Des Moines | Iowa | 50309 | United States |
| University of Kansas Cancer Center | Kansas City | Kansas | 66160 | United States |
| Lawrence Memorial Hospital | Lawrence | Kansas | 66044 | United States |
| University of Kansas Cancer Center-Overland Park | Overland Park | Kansas | 66210 | United States |
| Ascension Via Christi Hospitals Wichita | Wichita | Kansas | 67214 | United States |
| Wesley Medical Center | Wichita | Kansas | 67214 | United States |
| University of Kentucky/Markey Cancer Center | Lexington | Kentucky | 40536 | United States |
| Tulane University School of Medicine | New Orleans | Louisiana | 70112 | United States |
| Luminis Health Anne Arundel Medical Center | Annapolis | Maryland | 21401 | United States |
| University of Maryland/Greenebaum Cancer Center | Baltimore | Maryland | 21201 | United States |
| MedStar Franklin Square Medical Center/Weinberg Cancer Institute | Baltimore | Maryland | 21237 | United States |
| MedStar Good Samaritan Hospital | Baltimore | Maryland | 21239 | United States |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | 21287 | United States |
| UM Upper Chesapeake Medical Center | Bel Air | Maryland | 21014 | United States |
| Central Maryland Radiation Oncology in Howard County | Columbia | Maryland | 21044 | United States |
| UM Baltimore Washington Medical Center/Tate Cancer Center | Glen Burnie | Maryland | 21061 | United States |
| TidalHealth Richard A Henson Cancer Institute | Ocean Pines | Maryland | 21811 | United States |
| TidalHealth Peninsula Regional | Salisbury | Maryland | 21801 | United States |
| UM Saint Joseph Medical Center | Towson | Maryland | 21204 | United States |
| Lahey Hospital and Medical Center | Burlington | Massachusetts | 01805 | United States |
| Lowell General Hospital | Lowell | Massachusetts | 01854 | United States |
| UMass Memorial Medical Center - University Campus | Worcester | Massachusetts | 01655 | United States |
| Trinity Health Saint Joseph Mercy Hospital Ann Arbor | Ann Arbor | Michigan | 48106 | United States |
| McLaren Cancer Institute-Bay City | Bay City | Michigan | 48706 | United States |
| Trinity Health Medical Center - Brighton | Brighton | Michigan | 48114 | United States |
| Henry Ford Cancer Institute-Downriver | Brownstown | Michigan | 48183 | United States |
| Chelsea Hospital | Chelsea | Michigan | 48118 | United States |
| McLaren Cancer Institute-Clarkston | Clarkston | Michigan | 48346 | United States |
| Michigan Healthcare Professionals Clarkston | Clarkston | Michigan | 48346 | United States |
| Henry Ford Macomb Hospital-Clinton Township | Clinton Township | Michigan | 48038 | United States |
| Corewell Health Dearborn Hospital | Dearborn | Michigan | 48124 | United States |
| Wayne State University/Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Michigan Healthcare Professionals Farmington | Farmington Hills | Michigan | 48334 | United States |
| Genesys Hurley Cancer Institute | Flint | Michigan | 48503 | United States |
| McLaren Cancer Institute-Flint | Flint | Michigan | 48532 | United States |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital | Grand Rapids | Michigan | 49503 | United States |
| Trinity Health Grand Rapids Hospital | Grand Rapids | Michigan | 49503 | United States |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007 | United States |
| McLaren Cancer Institute-Lapeer Region | Lapeer | Michigan | 48446 | United States |
| Trinity Health Saint Mary Mercy Livonia Hospital | Livonia | Michigan | 48154 | United States |
| Michigan Healthcare Professionals Macomb | Macomb | Michigan | 48044 | United States |
| McLaren Cancer Institute-Macomb | Mount Clemens | Michigan | 48043 | United States |
| McLaren Cancer Institute-Central Michigan | Mount Pleasant | Michigan | 48858 | United States |
| Trinity Health Muskegon Hospital | Muskegon | Michigan | 49444 | United States |
| McLaren Cancer Institute-Owosso | Owosso | Michigan | 48867 | United States |
| McLaren Cancer Institute-Northern Michigan | Petoskey | Michigan | 49770 | United States |
| Trinity Health Saint Joseph Mercy Oakland Hospital | Pontiac | Michigan | 48341 | United States |
| McLaren-Port Huron | Port Huron | Michigan | 48060 | United States |
| Corewell Health William Beaumont University Hospital | Royal Oak | Michigan | 48073 | United States |
| Corewell Health Lakeland Hospitals - Saint Joseph Hospital | Saint Joseph | Michigan | 49085 | United States |
| Corewell Health Beaumont Troy Hospital | Troy | Michigan | 48085 | United States |
| Michigan Healthcare Professionals Troy | Troy | Michigan | 48098 | United States |
| Henry Ford West Bloomfield Hospital | West Bloomfield | Michigan | 48322 | United States |
| Mayo Clinic Health System in Albert Lea | Albert Lea | Minnesota | 56007 | United States |
| Saint Luke's Hospital of Duluth | Duluth | Minnesota | 55805 | United States |
| Mayo Clinic Health Systems-Mankato | Mankato | Minnesota | 56001 | United States |
| Abbott-Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States |
| Mayo Clinic Radiation Therapy-Northfield | Northfield | Minnesota | 55057 | United States |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| Park Nicollet Clinic - Saint Louis Park | Saint Louis Park | Minnesota | 55416 | United States |
| Saint Francis Medical Center | Cape Girardeau | Missouri | 63703 | United States |
| Siteman Cancer Center at West County Hospital | Creve Coeur | Missouri | 63141 | United States |
| Freeman Health System | Joplin | Missouri | 64804 | United States |
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | United States |
| North Kansas City Hospital | Kansas City | Missouri | 64116 | United States |
| University of Kansas Cancer Center - North | Kansas City | Missouri | 64154 | United States |
| University of Kansas Cancer Center at North Kansas City Hospital | North Kansas City | Missouri | 64116 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Siteman Cancer Center-South County | St Louis | Missouri | 63129 | United States |
| Missouri Baptist Medical Center | St Louis | Missouri | 63131 | United States |
| Mercy Hospital Saint Louis | St Louis | Missouri | 63141 | United States |
| Billings Clinic Cancer Center | Billings | Montana | 59101 | United States |
| Benefis Sletten Cancer Institute | Great Falls | Montana | 59405 | United States |
| Community Medical Center | Missoula | Montana | 59804 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Renown Regional Medical Center | Reno | Nevada | 89502 | United States |
| Wentworth-Douglass Hospital | Dover | New Hampshire | 03820 | United States |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center | Lebanon | New Hampshire | 03756 | United States |
| Memorial Sloan Kettering Basking Ridge | Basking Ridge | New Jersey | 07920 | United States |
| Englewood Hospital and Medical Center | Englewood | New Jersey | 07631 | United States |
| Memorial Sloan Kettering Monmouth | Middletown | New Jersey | 07748 | United States |
| Memorial Sloan Kettering Bergen | Montvale | New Jersey | 07645 | United States |
| Virtua Memorial | Mount Holly | New Jersey | 08060 | United States |
| Virtua Voorhees | Voorhees Township | New Jersey | 08043 | United States |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87106 | United States |
| Northwell Health Imbert Cancer Center | Bay Shore | New York | 11706 | United States |
| New York-Presbyterian/Brooklyn Methodist Hospital | Brooklyn | New York | 11215 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Memorial Sloan Kettering Commack | Commack | New York | 11725 | United States |
| Arnot Ogden Medical Center/Falck Cancer Center | Elmira | New York | 14905 | United States |
| Memorial Sloan Kettering Westchester | Harrison | New York | 10604 | United States |
| Northwell Health/Center for Advanced Medicine | Lake Success | New York | 11042 | United States |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York | 10032 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Lenox Hill Hospital | New York | New York | 10075 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Staten Island University Hospital | Staten Island | New York | 10305 | United States |
| State University of New York Upstate Medical University | Syracuse | New York | 13210 | United States |
| Montefiore Medical Center-Einstein Campus | The Bronx | New York | 10461 | United States |
| Montefiore Medical Center - Moses Campus | The Bronx | New York | 10467 | United States |
| Memorial Sloan Kettering Nassau | Uniondale | New York | 11553 | United States |
| Carolinas Medical Center/Levine Cancer Institute | Charlotte | North Carolina | 28203 | United States |
| Atrium Health Pineville/LCI-Pineville | Charlotte | North Carolina | 28210 | United States |
| Atrium Health University City/LCI-University | Charlotte | North Carolina | 28262 | United States |
| Atrium Health Cabarrus/LCI-Concord | Concord | North Carolina | 28025 | United States |
| Atrium Health Union/LCI-Union | Monroe | North Carolina | 28112 | United States |
| Atrium Health Cleveland/LCI-Cleveland | Shelby | North Carolina | 28150 | United States |
| Sanford Bismarck Medical Center | Bismarck | North Dakota | 58501 | United States |
| Sanford Roger Maris Cancer Center | Fargo | North Dakota | 58122 | United States |
| Summa Health System - Akron Campus | Akron | Ohio | 44304 | United States |
| Cleveland Clinic Akron General | Akron | Ohio | 44307 | United States |
| Geauga Hospital | Chardon | Ohio | 44024 | United States |
| Adena Regional Medical Center | Chillicothe | Ohio | 45601 | United States |
| Case Western Reserve University | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic Cancer Center/Fairview Hospital | Cleveland | Ohio | 44111 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
| Mount Carmel Health Center West | Columbus | Ohio | 43222 | United States |
| Dayton Physician LLC - Englewood | Dayton | Ohio | 45415 | United States |
| Mercy Cancer Center-Elyria | Elyria | Ohio | 44035 | United States |
| Cleveland Clinic Cancer Center Independence | Independence | Ohio | 44131 | United States |
| UH Seidman Cancer Center at Lake Health Mentor Campus | Mentor | Ohio | 44060 | United States |
| UH Seidman Cancer Center at Southwest General Hospital | Middleburg Heights | Ohio | 44130 | United States |
| University Hospitals Parma Medical Center | Parma | Ohio | 44129 | United States |
| Cleveland Clinic Cancer Center Strongsville | Strongsville | Ohio | 44136 | United States |
| UHHS-Westlake Medical Center | Westlake | Ohio | 44145 | United States |
| Cleveland Clinic Wooster Family Health and Surgery Center | Wooster | Ohio | 44691 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Legacy Mount Hood Medical Center | Gresham | Oregon | 97030 | United States |
| Legacy Good Samaritan Hospital and Medical Center | Portland | Oregon | 97210 | United States |
| Jefferson Abington Hospital | Abington | Pennsylvania | 19001 | United States |
| Crozer-Keystone Regional Cancer Center at Broomall | Broomall | Pennsylvania | 19008 | United States |
| Bryn Mawr Hospital | Bryn Mawr | Pennsylvania | 19010 | United States |
| Christiana Care Health System-Concord Health Center | Chadds Ford | Pennsylvania | 19317 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| Northeast Radiation Oncology Center | Dunmore | Pennsylvania | 18512 | United States |
| Adams Cancer Center | Gettysburg | Pennsylvania | 17325 | United States |
| Crozer Regional Cancer Center at Brinton Lake | Glen Mills | Pennsylvania | 19342 | United States |
| Geisinger Medical Oncology-Lewisburg | Lewisburg | Pennsylvania | 17837 | United States |
| Riddle Memorial Hospital | Media | Pennsylvania | 19063 | United States |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| Jefferson Torresdale Hospital | Philadelphia | Pennsylvania | 19114 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| Penn State Health Saint Joseph Medical Center | Reading | Pennsylvania | 19605 | United States |
| Reading Hospital | West Reading | Pennsylvania | 19611 | United States |
| Geisinger Wyoming Valley/Henry Cancer Center | Wilkes-Barre | Pennsylvania | 18711 | United States |
| Lankenau Medical Center | Wynnewood | Pennsylvania | 19096 | United States |
| WellSpan Health-York Cancer Center | York | Pennsylvania | 17403 | United States |
| AnMed Health Cancer Center | Anderson | South Carolina | 29621 | United States |
| Prisma Health Cancer Institute - Spartanburg | Boiling Springs | South Carolina | 29316 | United States |
| Prisma Health Cancer Institute - Faris | Greenville | South Carolina | 29605 | United States |
| Prisma Health Cancer Institute - Eastside | Greenville | South Carolina | 29615 | United States |
| Self Regional Healthcare | Greenwood | South Carolina | 29646 | United States |
| The Radiation Oncology Center-Hilton Head/Bluffton | Hilton Head Island | South Carolina | 29926 | United States |
| Lancaster Radiation Therapy Center | Lancaster | South Carolina | 29720 | United States |
| Rock Hill Radiation Therapy Center | Rock Hill | South Carolina | 29730 | United States |
| Rapid City Regional Hospital | Rapid City | South Dakota | 57701 | United States |
| Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota | 57117-5134 | United States |
| Covenant Health Cancer Centers | Knoxville | Tennessee | 37916 | United States |
| Blount Memorial Hospital | Maryville | Tennessee | 37804 | United States |
| Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
| University of Texas Medical Branch | Galveston | Texas | 77555-0565 | United States |
| UT MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| UTMB Cancer Center at Victory Lakes | League City | Texas | 77573 | United States |
| Ogden Regional Medical Center | Ogden | Utah | 84405 | United States |
| Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah | 84112 | United States |
| Central Vermont Medical Center/National Life Cancer Treatment | Berlin Corners | Vermont | 05602 | United States |
| University of Vermont Medical Center | Burlington | Vermont | 05401 | United States |
| Dartmouth Cancer Center - North | Saint Johnsbury | Vermont | 05819 | United States |
| VCU Massey Comprehensive Cancer Center | Richmond | Virginia | 23298 | United States |
| West Virginia University Healthcare | Morgantown | West Virginia | 26506 | United States |
| Wheeling Hospital/Schiffler Cancer Center | Wheeling | West Virginia | 26003 | United States |
| Langlade Hospital and Cancer Center | Antigo | Wisconsin | 54409 | United States |
| Ascension Southeast Wisconsin Hospital - Elmbrook Campus | Brookfield | Wisconsin | 53045 | United States |
| Mayo Clinic Health System-Eau Claire Clinic | Eau Claire | Wisconsin | 54701 | United States |
| Mayo Clinic Health System Eau Claire Hospital-Luther Campus | Eau Claire | Wisconsin | 54703 | United States |
| Ascension Saint Francis - Reiman Cancer Center | Franklin | Wisconsin | 53132 | United States |
| Aurora Cancer Care-Grafton | Grafton | Wisconsin | 53024 | United States |
| Aurora BayCare Medical Center | Green Bay | Wisconsin | 54311 | United States |
| University of Wisconsin Carbone Cancer Center - Johnson Creek | Johnson Creek | Wisconsin | 53038 | United States |
| Aurora Cancer Care-Kenosha South | Kenosha | Wisconsin | 53142 | United States |
| Gundersen Lutheran Medical Center | La Crosse | Wisconsin | 54601 | United States |
| Mayo Clinic Health System-Franciscan Healthcare | La Crosse | Wisconsin | 54601 | United States |
| University of Wisconsin Carbone Cancer Center - University Hospital | Madison | Wisconsin | 53792 | United States |
| Froedtert Menomonee Falls Hospital | Menomonee Falls | Wisconsin | 53051 | United States |
| Aurora Saint Luke's Medical Center | Milwaukee | Wisconsin | 53215 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Aurora Sinai Medical Center | Milwaukee | Wisconsin | 53233 | United States |
| Vince Lombardi Cancer Clinic - Oshkosh | Oshkosh | Wisconsin | 54904 | United States |
| Ascension All Saints Hospital | Racine | Wisconsin | 53405 | United States |
| Marshfield Medical Center-River Region at Stevens Point | Stevens Point | Wisconsin | 54482 | United States |
| Aurora Medical Center in Summit | Summit | Wisconsin | 53066 | United States |
| Vince Lombardi Cancer Clinic-Two Rivers | Two Rivers | Wisconsin | 54241 | United States |
| Aspirus Regional Cancer Center | Wausau | Wisconsin | 54401 | United States |
| Aurora West Allis Medical Center | West Allis | Wisconsin | 53227 | United States |
| Marshfield Medical Center - Weston | Weston | Wisconsin | 54476 | United States |
| Aspirus Cancer Care - Wisconsin Rapids | Wisconsin Rapids | Wisconsin | 54494 | United States |
| Kingston Health Sciences Centre | Kingston | Ontario | K7L 2V7 | Canada |
| London Regional Cancer Program | London | Ontario | N6A 4L6 | Canada |
| Stronach Regional Health Centre at Southlake | Newmarket | Ontario | L3Y 2P9 | Canada |
| Ottawa Hospital and Cancer Center-General Campus | Ottawa | Ontario | K1H 8L6 | Canada |
| University Health Network-Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| CHUM - Centre Hospitalier de l'Universite de Montreal | Montreal | Quebec | H2X 3E4 | Canada |
| The Research Institute of the McGill University Health Centre (MUHC) | Montreal | Quebec | H3H 2R9 | Canada |
| CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ) | Québec | Quebec | G1R 2J6 | Canada |
| Centre Hospitalier Universitaire de Sherbrooke-Fleurimont | Sherbrooke | Quebec | J1H 5N4 | Canada |
| Allan Blair Cancer Centre | Regina | Saskatchewan | S4T 7T1 | Canada |
| Saskatoon Cancer Centre | Saskatoon | Saskatchewan | S7N 4H4 | Canada |
| Derived |
| Ishibashi A, Kurosaki H, Miura K, Utsumi N, Sakurai H. Influence of Modulation Factor on Treatment Plan Quality and Irradiation Time in Hippocampus-Sparing Whole-Brain Radiotherapy Using Tomotherapy. Technol Cancer Res Treat. 2021 Jan-Dec;20:15330338211045497. doi: 10.1177/15330338211045497. |
PCI with hippocampal avoidance (HA) using intensity-modulated radiation therapy (IMRT) for 2 weeks, 5 fractions/week.
| Phase II Analysis | These participants are included in the phase III analysis. |
|
| Adverse Event Population | Received radiation therapy. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Randomized participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PCI Using 3DCRT | Prophylactic cranial irradiation (PCI) using three-dimensional conformal radiation therapy (3DCRT) for 2 weeks, 5 fractions/week. |
| BG001 | PCI With HA Using IMRT | PCI with hippocampal avoidance (HA) using intensity-modulated radiation therapy (IMRT) for 2 weeks, 5 fractions/week. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Zubrod performance status | 0 = Asymptomatic; 1 = Symptomatic but completely ambulatory; 2 = Symptomatic, <50% in bed during the day; 3 = Symptomatic, >50% in bed, but not bedbound; 4 = Bedbound; 5 = Death | Count of Participants | Participants |
| |||||||||||||||
| Planned concurrent memantine use | Count of Participants | Participants |
| ||||||||||||||||
| Extent of disease | A definition of these terms was not provided in the protocol and the study sites could interpret the terms differently. LD generally refers to disease confined to the hemithorax of origin, the mediastinum, or the supraclavicular nodes and which can be encompassed within a tolerable radiation therapy port. There is no general agreement on pleural effusion, massive pulmonary tumor, and contralateral supraclavicular nodes. ED generally refers to disease that has spread beyond the supraclavicular areas and is too widespread to be considered LD. Distant metastases always indicate ED. | Count of Participants | Participants |
| |||||||||||||||
| Education level | Count of Participants | Participants |
| ||||||||||||||||
| Smoking status (self-reported) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Deterioration in HVLT-R Delayed Recall Score at Six Months (Phase III) | The HVLT-R delayed recall test assesses verbal learning and memory. The test involves memorizing a list of 12 nouns for 3 consecutive trials to recall after a 20-minute delay. The score is the sum of the number of words correctly recalled and ranges from 0 to 36, with a higher score indicating better functioning. Deterioration is defined a decrease from baseline of at least 3 points. | Randomized patients with score at baseline and 6 months | Posted | Count of Participants | Participants | Baseline and six months |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Intracranial Relapse at 12 Months (Phase II) | Intracranial relapse, defined as the development of a new brain metastasis as documented on brain MRI with contrast or head CT with contrast. | Phase II randomized participants on study for at least one year. | Posted | Count of Participants | Participants | From baseline to 12 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Neurocognitive Failure (Phase III) | Neurocognitive failure is defined as the first instance of neurocognitive decline in any of six assessments, as determined my reliable change index: Hopkins Verbal Learning Test-Revised (HVLT-R) Total Recall, HVLT-R Delayed Recall, HVLT-R Delayed Recognition, Trail Making Test (TMT) part A, TMT part B, and Controlled Oral Word Association (COWA). Failure time is defined as time from randomization to failure, death (competing event), or last follow-up (censored). Neurocognitive failure rates are estimated using the cumulative incidence method. The distributions of failure times are compared, which is reported in the statistical analysis results. Six-month rates are reported here. Analysis occurred after all patients had been on study for at least six months. | Randomized participants | Posted | Number | 95% Confidence Interval | percentage of participants | Randomization to date of failure, death, or last known follow-up whichever occurred first. Maximum follow-up at time of analysis was 7.2 years. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Deterioration in HVLT-R Total Recall Score (Phase III) | The HVLT-R Total Recall score assesses verbal learning and memory. The test involves memorizing a list of 12 nouns for 3 consecutive trials. Raw score is the sum of the number of targets correctly recalled, ranging from 0 to 36. Higher score indicates better functioning. Deterioration is defined a decrease from baseline of at least 5 points. | Randomized patients with score at baseline and 3, 6, or 12 months. | Posted | Count of Participants | Participants | Baseline, 3, 6, 12 months. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Deterioration in HVLT-R Total Recall Score (Phase III) | he HVLT-R Total Recall score assesses verbal learning and memory. The test involves memorizing a list of 12 nouns for 3 consecutive trials. Raw score is the sum of the number of targets correctly recalled, ranging from 0 to 36. Higher score indicates better functioning. Deterioration is defined a decrease from baseline of at least 5 points. | Randomized patients with score at baseline and 18 or 24 months. | Posted | Count of Participants | Participants | Baseline,18, 24 months. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Deterioration in HVLT-R Delayed Recall Score (Phase III) | The HVLT-R Delayed Recall test assesses verbal learning and memory. After memorizing a list of 12 nouns for 3 consecutive trials, this test requires recalling the 12 targets after a 20-minute delay. Raw scores are sum of the number of targets correctly recalled. The score ranges from 0 to 12. A higher score indicates better functioning. Deterioration is defined a decrease from baseline of at least 3 points. Six-month results are reported as the primary endpoint. | Randomized patients with HVLT-R Delayed Recall score at baseline and: 3 or 12 months. | Posted | Count of Participants | Participants | Baseline, 3, 12 months. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Deterioration in HVLT-R Delayed Recall Score (Phase III) | The HVLT-R Delayed Recall test assesses verbal learning and memory. After memorizing a list of 12 nouns for 3 consecutive trials, this test requires recalling the 12 targets after a 20-minute delay. Raw scores are sum of the number of targets correctly recalled. The score ranges from 0 to 12. A higher score indicates better functioning. Deterioration is defined a decrease from baseline of at least 3 points. | Randomized patients with score at baseline and 18 or 24 months. | Posted | Count of Participants | Participants | Baseline, 18, 24 months. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Deterioration in HVLT-R Delayed Recognition Score (Phase III) | The HVLT-R Delayed Recognition assesses verbal learning and memory. After memorizing a list of 12 nouns for 3 consecutive trials and recalling the 12 targets after a 20-minute delay, the test involves then identifying the 12 targets from a list of semantically related or unrelated items (delayed recognition). Raw scores are the sum of targets incorrectly identified subtracted from the sum of the number of targets correctly identified. The score ranges from -12 to 12 for recognition. A higher score indicates better functioning. Deterioration is defined a decrease from baseline of at least 2 points. | Randomized patients with score at baseline and: 3, 6, or 12 months. | Posted | Count of Participants | Participants | Baseline, 3, 6, 12 months. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Deterioration in HVLT-R Delayed Recognition Score (Phase III) | The HVLT-R Delayed Recognition assesses verbal learning and memory. After memorizing a list of 12 nouns for 3 consecutive trials and recalling the 12 targets after a 20-minute delay, the test involves then identifying the 12 targets from a list of semantically related or unrelated items (delayed recognition). Raw scores are the sum of targets incorrectly identified subtracted from the sum of the number of targets correctly identified. The score ranges from -12 to 12 for recognition. A higher score indicates better functioning. Deterioration is defined a decrease from baseline of at least 2 points. | Randomized patients with score at baseline and 18 or 24 months. | Posted | Count of Participants | Participants | Baseline, 18, 24 months. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Deterioration in Trail Making Test (TMT) Part A (Phase III) | The TMT is a neuropsychological test of visual attention and task switching that can provide information about visual search speed, scanning, speed of processing, mental flexibility, and executive functioning. Subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. There are two parts to the test: in the first (Part A, reported here), the targets are all numbers (1, 2, 3, etc.) and the test taker needs to connect them in sequential order. The score is the amount of time, in seconds, that it takes the patient to complete the maze. The range for Part A is 0 to 180 (3 minutes). Lower scores indicate better functioning. Deterioration is defined an increase from baseline of at least 12 seconds. | Randomized patients with TMT Part A at baseline and 3, 6, or 12 months. | Posted | Count of Participants | Participants | Baseline, 3, 6, 12 months. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Deterioration in Trail Making Test (TMT) Part A (Phase III) | The TMT is a neuropsychological test of visual attention and task switching that can provide information about visual search speed, scanning, speed of processing, mental flexibility, and executive functioning. Subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. There are two parts to the test: in the first (Part A, reported here), the targets are all numbers (1, 2, 3, etc.) and the test taker needs to connect them in sequential order. The score is the amount of time, in seconds, that it takes the patient to complete the maze. The range for Part A is 0 to 180 (3 minutes). Lower scores indicate better functioning. Deterioration is defined an increase from baseline of at least 12 seconds. | Randomized patients with score at baseline and 18 or 24 months. | Posted | Count of Participants | Participants | Baseline, 18, 24 months. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Deterioration in TMT Part B Score (Phase III) | The TMT is a neuropsychological test of visual attention and task switching that can provide information about visual search speed, scanning, speed of processing, mental flexibility, and executive functioning. Subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. There are two parts to the test: in the second part (Part B, reported here), the subject alternates between numbers and letters (1, A, 2, B, etc.). The score is the amount of time, in seconds, that it takes the patient to complete the maze. The score range for Part B is 0 to 300 (5 minutes). Lower scores indicate better functioning. Deterioration is defined an increase from baseline of at least 26 seconds. | Randomized patients with score at baseline and 3, 6, or 12 months. | Posted | Count of Participants | Participants | Baseline, 3, 6, 12 months. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Deterioration in TMT Part B Score (Phase III) | The TMT is a neuropsychological test of visual attention and task switching that can provide information about visual search speed, scanning, speed of processing, mental flexibility, and executive functioning. Subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. There are two parts to the test: in the second part (Part B, reported here), the subject alternates between numbers and letters (1, A, 2, B, etc.). The score is the amount of time, in seconds, that it takes the patient to complete the maze. The score range for Part B is 0 to 300 (5 minutes). Lower scores indicate better functioning. Deterioration is defined an increase from baseline of at least 26 seconds. If reporting a score on a scale, please include the unabbreviated scale title, the minimum and maximum values, and whether higher scores mean a better or worse outcome. | Randomized patients with score at baseline and 18 or 24 months. | Posted | Count of Participants | Participants | Baseline, 18, 24 months. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Deterioration in Controlled Oral Word Association (COWA) Score (Phase III) | The COWA is a verbal fluency test that measures spontaneous production of words belonging to the same category or beginning with some designated letter. Patients are given 1 minute to name as many words as possible beginning with the designated letter. The procedure is then repeated for the remaining two letters. Two alternate forms of the COWA are employed to minimize practice effects. The score is the sum of the correct responses with a range of 0 to infinity. A higher score indicates better functioning. Deterioration is defined an increase from baseline of at least 12 words. | Randomized patients with score at baseline and 3, 6, or 12 months. | Posted | Count of Participants | Participants | Baseline, 3, 6, 12 months. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Deterioration in Controlled Oral Word Association (COWA) Score (Phase III) | The COWA is a verbal fluency test that measures spontaneous production of words belonging to the same category or beginning with some designated letter. Patients are given 1 minute to name as many words as possible beginning with the designated letter. The procedure is then repeated for the remaining two letters. Two alternate forms of the COWA are employed to minimize practice effects. The score is the sum of the correct responses with a range of 0 to infinity. A higher score indicates better functioning. Deterioration is defined an increase from baseline of at least 12 words. | Randomized patients with score at baseline and 18 or 24 months. | Posted | Count of Participants | Participants | Baseline,18, 24 months. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants by Highest Grade Adverse Event Reported (Phase III) | Common Terminology Criteria for Adverse Events (version 5) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. | Randomized participants who received radiation therapy. | Posted | Count of Participants | Participants | From start of treatment to last known follow-up . Maximum follow-up time was 7.2 years. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Deterioration in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (QLQ-C30) Global Health Status (Phase III) | The QLQ-C30 is a 30-item self-report questionnaire used to assess the health-related quality of life (QOL) of cancer patients participating in international clinical trials. Global Health Status is considered a measure of overall quality of life and is calculated from two questions whose raw scores are averaged and then transformed to a range of 0 (worst) to 100 (best). Deterioration is defined a reduction of 10% from baseline. | Randomized patients with score at baseline and 3, 6, or 12 months. | Posted | Count of Participants | Participants | Baseline, 3, 6, 12 months. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Deterioration in EORTC QLQ-C30 Global Health Status (Phase III) | The QLQ-C30 is a 30-item self-report questionnaire used to assess the health-related quality of life (QOL) of cancer patients participating in international clinical trials. Global Health Status is considered a measure of overall quality of life and is calculated from two questions whose raw scores are averaged and then transformed to a range of 0 (worst) to 100 (best). Deterioration is defined a reduction of 10% from baseline. | Randomized patients with score at baseline and 18 or 24 months. | Posted | Count of Participants | Participants | Baseline,18, 24 months. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Deterioration in EORTC QLQ-C30 Physical Functioning Score (Phase III) | The EORTC QLQ-C30 is a 30-item self-report questionnaire used to assess the health-related quality of life of cancer patients participating in international clinical trials. A functional scale raw score is transformed to a range of 0 (worst) to 100 (best) in which a high score represents a healthy level of functioning. Deterioration is defined a reduction of 10% from baseline. | Randomized patients with score at baseline and 3, 6, or 12 months. | Posted | Count of Participants | Participants | Baseline, 3, 6, 12 months. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Deterioration in EORTC QLQ-C30 Physical Functioning Score (Phase III) | The EORTC QLQ-C30 is a 30-item self-report questionnaire used to assess the health-related quality of life of cancer patients participating in international clinical trials. A functional scale raw score is transformed to a range of 0 (worst) to 100 (best) in which a high score represents a healthy level of functioning. Deterioration is defined a reduction of 10% from baseline. | Randomized patients with score at baseline and 18 or 24 months. | Posted | Count of Participants | Participants | Baseline,18, 24 months. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Deterioration in EORTC QLQ-C30 Role Functioning Score (Phase III) | The EORTC QLQ-C30 is a 30-item self-report questionnaire used to assess the health-related quality of life (QOL) of cancer patients participating in international clinical trials. A functional scale raw score is transformed to a range of 0 (worst) to 100 (best) in which a high score represents a healthy level of functioning. Deterioration is defined a reduction of 10% from baseline. | Randomized patients with score at baseline and 3, 6, or 12 months. | Posted | Count of Participants | Participants | Baseline, 3, 6, 12 months. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Deterioration in EORTC QLQ-C30 Role Functioning Score (Phase III) | The EORTC QLQ-C30 is a 30-item self-report questionnaire used to assess the health-related quality of life (QOL) of cancer patients participating in international clinical trials. A functional scale raw score is transformed to a range of 0 (worst) to 100 (best) in which a high score represents a healthy level of functioning. Deterioration is defined a reduction of 10% from baseline. | Randomized patients with score at baseline and 18 or 24 months. | Posted | Count of Participants | Participants | Baseline,18, 24 months. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Deterioration in EORTC QLQ-C30 Emotional Functioning Score (Phase III) | The EORTC QLQ-C30 is a 30-item self-report questionnaire used to assess the health-related quality of life of cancer patients participating in international clinical trials. A functional scale raw score is transformed to a range of 0 (worst) to 100 (best) in which a high score represents a healthy level of functioning. Deterioration is defined a reduction of 10% from baseline. | Randomized patients with score at baseline and 3, 6, or 12 months. | Posted | Count of Participants | Participants | Baseline, 3, 6, 12 months. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Deterioration in EORTC QLQ-C30 Emotional Functioning Score (Phase III) | The EORTC QLQ-C30 is a 30-item self-report questionnaire used to assess the health-related quality of life of cancer patients participating in international clinical trials. A functional scale raw score is transformed to a range of 0 (worst) to 100 (best) in which a high score represents a healthy level of functioning. Deterioration is defined a reduction of 10% from baseline. | Randomized patients with score at baseline and 18 or 24 months. | Posted | Count of Participants | Participants | Baseline,18, 24 months. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Deterioration in EORTC QLQ-C30 Social Functioning Score (Phase III) | The EORTC QLQ-C30 is a 30-item self-report questionnaire used to assess the health-related quality of life (QOL) of cancer patients participating in international clinical trials. A functional scale raw score is transformed to a range of 0 (worst) to 100 (best) in which a high score represents a healthy level of functioning. Deterioration is defined a reduction of 10% from baseline. | Randomized patients with score at baseline and 3, 6, or 12 months. | Posted | Count of Participants | Participants | Baseline, 3, 6, 12 months. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Deterioration in EORTC QLQ-C30 Social Functioning Score (Phase III) | The EORTC QLQ-C30 is a 30-item self-report questionnaire used to assess the health-related quality of life (QOL) of cancer patients participating in international clinical trials. A functional scale raw score is transformed to a range of 0 (worst) to 100 (best) in which a high score represents a healthy level of functioning. Deterioration is defined a reduction of 10% from baseline. | Randomized patients with score at baseline and 18 or 24 months. | Posted | Count of Participants | Participants | Baseline,18, 24 months. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Deterioration in EORTC QLQ-C30 Cognitive Functioning Score (Phase III) | The EORTC QLQ-C30 is a 30-item self-report questionnaire used to assess the health-related quality of life (QOL) of cancer patients participating in international clinical trials. A functional scale raw score is transformed to a range of 0 (worst) to 100 (best) in which a high score represents a healthy level of functioning. Deterioration is defined a reduction of 10% from baseline. | Randomized patients with score at baseline and 3, 6, or 12 months. | Posted | Count of Participants | Participants | Baseline, 3, 6, 12 months. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Deterioration in EORTC QLQ-C30 Cognitive Functioning Score (Phase III) | The EORTC QLQ-C30 is a 30-item self-report questionnaire used to assess the health-related quality of life (QOL) of cancer patients participating in international clinical trials. A functional scale raw score is transformed to a range of 0 (worst) to 100 (best) in which a high score represents a healthy level of functioning. Deterioration is defined a reduction of 10% from baseline. | Randomized patients with score at baseline and 18 or 24 months. | Posted | Count of Participants | Participants | Baseline,18, 24 months. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Deterioration in EORTC Quality of Life Questionnaire BN-20 (QLQ-BN20) Motor Dysfunction Score (Phase III) | The EORTC QLQ-BN20 is a 20-item self-report questionnaire supplement to the QLQ-C30 for patients used to assess the health-related quality of life of brain cancer patients. A symptom scale raw score is transformed to a range of 0 (best) to 100 (worst) in which a high score represents a high level of symptomatology/problems. For patients with a baseline score of 0, a follow-up score of ≥ 10 is considered as a deterioration. Otherwise, a 10% increase is considered as a deterioration. | Randomized patients with score at baseline and 3, 6, or 12 months. | Posted | Count of Participants | Participants | Baseline, 3, 6, 12 months. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Deterioration in EORTC QLQ-BN20 Motor Dysfunction Score (Phase III) | The EORTC QLQ-BN20 is a 20-item self-report questionnaire supplement to the QLQ-C30 for patients used to assess the health-related quality of life of brain cancer patients. A symptom scale raw score is transformed to a range of 0 (best) to 100 (worst) in which a high score represents a high level of symptomatology/problems. For patients with a baseline score of 0, a follow-up score of ≥ 10 is considered as a deterioration. Otherwise, a 10% increase is considered as a deterioration. | Randomized patients with score at baseline and 18 or 24 months. | Posted | Count of Participants | Participants | Baseline,18, 24 months. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Deterioration in EORTC QLQ-BN20 Communication Deficit Score (Phase III) | The QLQ-BN20 is a 20-item self-report questionnaire supplement to the QLQ-C30 for patients used to assess the health-related quality of life of brain cancer patients. A symptom scale raw score is transformed to a range of 0 (best) to 100 (worst) in which a high score represents a high level of symptomatology/problems. For patients with a baseline score of 0, a follow-up score of ≥ 10 is considered as a deterioration. Otherwise, a 10% increase is considered as a deterioration. | Randomized patients with score at baseline and 3, 6, or 12 months. | Posted | Count of Participants | Participants | Baseline, 3, 6, 12 months. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Deterioration in EORTC QLQ-BN20 Communication Deficit Score (Phase III) | The QLQ-BN20 is a 20-item self-report questionnaire supplement to the QLQ-C30 for patients used to assess the health-related quality of life of brain cancer patients. A symptom scale raw score is transformed to a range of 0 (best) to 100 (worst) in which a high score represents a high level of symptomatology/problems. For patients with a baseline score of 0, a follow-up score of ≥ 10 is considered as a deterioration. Otherwise, a 10% increase is considered as a deterioration. | Randomized patients with score at baseline and 18 or 24 months. | Posted | Count of Participants | Participants | Baseline,18, 24 months. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Correlation of Quality of Life and Neurocognitive Function (NCF) Measures at 6 Months | The Pearson correlation coefficient was calculated for EORTC QLQ-C30 (physical, role, emotional, cognitive, and social functioning domains and global health status) and QLQ-BN20 (motor dysfunction and communication deficit) versus the standardized neurocognitive function (HVLT-R total recall, HVLT-R delayed recall, HVLT-R delayed recognition, COWA, TMT parts A and B) and the Clinical Trial Battery Composite (CTB Comp) score (mean of the z-scores for the six NCF scores) for all patients, treatment arms combined. The Pearson correlation coefficient is computed for each pair of measurements, resulting in 48 correlation coefficients. Possible values range from -1 (negatively correlated) to 1(positively correlated), with 0 indicating no correlation. A correlation with a value in range -0.35 to 0.35 is considered weak and is indicated by "0" in the table. Because of the large number of comparisons, only individual correlation coefficients outside that range are listed here. | Randomized participants with values at 6 months. The protocol specifies that the treatment arms are combined into a single group for this outcome measure. | Posted | Number | correlation coefficient | 6 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incremental Cost-per Quality-adjusted Life Year (QALY) (Cost-effectiveness as Measured by the EQ-5D (Phase III) | The incremental cost per quality-adjusted life year (QALY) ratio will be calculated as total cost of the PCI with HA using IMRT arm (Arm 2) minus total cost of the PCI using 3DCRT arm (Arm 1), divided by the quality adjusted survival of the Arm 1 patients minus the quality adjusted survival of Arm 2 patients. | Not Posted | Aug 2026 | Baseline to two years | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (Phase III) | Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. Analysis occurred after all patients had been on study for at least 8 months. | Randomized participants | Posted | Median | 95% Confidence Interval | months | From the date of randomization to the date of death or last follow-up. Maximum follow-up time at time of analysis was 7.2 years. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Intracranial Relapse Rate (Phase III) | Intracranial relapse is defined as the development of a new brain metastasis as documented on brain MRI with contrast or head CT with contrast. Time to intracranial relapse is defined as time from randomization to the date of first intracranial relapse, last known follow-up (censored), or death without intracranial relapse (competing risk), whichever occurred first. Intracranial relapse rates are estimated using the cumulative incidence method. The distributions of intracranial relapse times are compared between the arms, which is reported in the statistical analysis results. One-year rates are provided here. Analysis occurred at time of the phase III primary analysis. | Randomized participants | Posted | Number | 95% Confidence Interval | percentage of participants | From date of randomization to date of intracranial relapse, death, or last known follow-up, whichever occurred first. Maximum follow-up at time of analysis was 7.2 years. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | White Matter Injury and Hippocampal Volume on Neurocognitive Function (Phase III) | Pearson correlation coefficients will be used to assess the effect of hippocampal volume and FLAIR volume change on baseline neurocognitive function, as measured by the HVLT-R, COWA, and TMT, separately for each arm. | Not Posted | Aug 2026 | Baseline to 6 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Deterioration in HVLT-R Delayed Recall Score at Six Months (Phase III) by Sex | NIH-required analysis. The HVLT-R delayed recall test assesses verbal learning and memory. The test involves memorizing a list of 12 nouns for 3 consecutive trials to recall after a 20-minute delay. The score is the sum of the number of words correctly recalled and ranges from 0 to 36, with a higher score indicating better functioning. Deterioration is defined a decrease from baseline of at least 3 points. | Randomized patients with score at baseline and 6 months. Data were stratified by sex. | Posted | Count of Participants | Participants | Baseline and six months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Deterioration in HVLT-R Delayed Recall Score at Six Months (Phase III) by Ethnicity | NIH-required analysis. The HVLT-R delayed recall test assesses verbal learning and memory. The test involves memorizing a list of 12 nouns for 3 consecutive trials to recall after a 20-minute delay. The score is the sum of the number of words correctly recalled and ranges from 0 to 36, with a higher score indicating better functioning. Deterioration is defined a decrease from baseline of at least 3 points. | Randomized patients with score at baseline and 6 months. Data were stratified by ethnicity. | Posted | Count of Participants | Participants | Baseline and six months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Deterioration in HVLT-R Delayed Recall Score at Six Months (Phase III) by Race | NIH-required analysis. The HVLT-R delayed recall test assesses verbal learning and memory. The test involves memorizing a list of 12 nouns for 3 consecutive trials to recall after a 20-minute delay. The score is the sum of the number of words correctly recalled and ranges from 0 to 36, with a higher score indicating better functioning. Deterioration is defined a decrease from baseline of at least 3 points. | Randomized patients with score at baseline and 6 months. Data were stratified by race. | Posted | Count of Participants | Participants | Baseline and six months |
|
|
Baseline to last known follow-up or death. Maximum follow-up time was 7.2 years.
All-cause mortality was assessed in randomized participants. Adverse events were assessed in randomized participants who started radiation therapy.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PCI Using 3DCRT | Prophylactic cranial irradiation (PCI) using three-dimensional conformal radiation therapy (3DCRT) for 2 weeks, 5 fractions/week. | 118 | 196 | 26 | 191 | 154 | 191 |
| EG001 | PCI With HA Using IMRT | PCI with hippocampal avoidance (HA) using intensity-modulated radiation therapy (IMRT) for 2 weeks, 5 fractions/week. | 112 | 197 | 17 | 189 | 152 | 189 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Blood and lymphatic system disorders - Other | Blood and lymphatic system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Mitral valve disease | Cardiac disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Pericarditis | Cardiac disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Endocrine disorders - Other | Endocrine disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Chills | General disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Fever | General disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Pain | General disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Sudden death NOS | General disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Hepatobiliary disorders - Other | Hepatobiliary disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Serum sickness | Immune system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Biliary tract infection | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Infections and infestations - Other | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Burn | Injury, poisoning and procedural complications | CTCAE (5.0) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE (5.0) | Non-systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | CTCAE (5.0) | Non-systematic Assessment |
| |
| Injury, poisoning and procedural complications - Other | Injury, poisoning and procedural complications | CTCAE (5.0) | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Musculoskeletal and connective tissue disorder - Other | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (5.0) | Non-systematic Assessment |
| |
| Amnesia | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Central nervous system necrosis | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Cognitive disturbance | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Nervous system disorders - Other | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Paresthesia | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Psychiatric disorders - Other | Psychiatric disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Respiratory, thoracic and mediastinal disorders - Other | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Hearing impaired | Ear and labyrinth disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Blurred vision | Eye disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Pain | General disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Dermatitis radiation | Injury, poisoning and procedural complications | CTCAE (5.0) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE (5.0) | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Amnesia | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Memory impairment | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
|
Phase II participants were included in the phase III analysis.
PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wendy Seiferheld | NRG Oncology | 2155743208 | seiferheldw@nrgoncology.org |
| Mar 12, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 1, 2022 | Mar 12, 2024 | ICF_001.pdf |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
Not provided
Not provided
| 50-59 |
|
| 60-69 |
|
| ≥ 70 |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 1 |
|
| 2 |
|
| Yes |
|
| Extensive stage disease (ED) |
|
| More than grade school and did not graduate high school |
|
| High school graduate or GED |
|
| Some college or associate's degree |
|
| Bachelor's degree |
|
| Advanced degree |
|
| Unknown |
|
| Former smoker |
|
| Current smoker |
|
| Unknown |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Participants |
|
|
|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
|
|
| Participants |
|
|
|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|