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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-00030 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| NRG-CC001 | Other Identifier | NRG Oncology | |
| NRG-CC001 | Other Identifier | DCP | |
| NRG-CC001 | Other Identifier | CTEP | |
| UG1CA189867 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This randomized phase III trial compares memantine hydrochloride and whole-brain radiotherapy with or without hippocampal avoidance in reducing neurocognitive decline in patients with cancer that has spread from the primary site (place where it started) to the brain. Whole brain radiotherapy (WBRT) is the most common treatment for brain metastasis. Unfortunately, the majority of patients with brain metastases experience cognitive (such as learning and memory) deterioration after WBRT. Memantine hydrochloride may enhance cognitive function by binding to and inhibiting channels of receptors located in the central nervous system. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Using radiation techniques, such as intensity modulated radiotherapy to avoid the hippocampal region during WBRT, may reduce the radiation dose to the hippocampus and help limit the radiation-induced cognitive decline. It is not yet known whether giving memantine hydrochloride and WBRT with or without hippocampal avoidance works better in reducing neurocognitive decline in patients with brain metastases.
PRIMARY OBJECTIVES:
I. Determine whether the addition of whole-brain radiotherapy with hippocampal avoidance (HA-WBRT) increases time to neurocognitive failure at months 2, 4, 6, and 12 as measured by neurocognitive decline on a battery of tests: the Hopkins Verbal Learning Test-Revised (HVLT-R) for Total Recall, Delayed Recall, and Delayed Recognition, Controlled Oral Word Association (COWA), and the Trail Making Test (TMT) Parts A and B.
SECONDARY OBJECTIVES:
I. Determine whether the addition of HA-WBRT preserves neurocognitive function at months 2, 4, 6, and 12 as separately measured by each test, the HVLT-R for Total Recall, Delayed Recall, and Delayed Recognition; COWA; and TMT Parts A and B.
II. Evaluate the potential benefit of HA-WBRT in symptom burden, as measured by the M. D. Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT).
III. Assessment of quality adjusted survival and cost analysis using the five-level version of the EuroQol five-dimensional (EQ-5D-5L).
IV. Compare cumulative incidence of progression and overall survival after WBRT versus HA-WBRT.
V. Compare adverse events between the treatment arms according to the Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0 criteria.
TERTIARY OBJECTIVES:
I. Collect serum, plasma, and imaging studies for future translational research analyses.
II. Evaluate magnetic resonance (MR) imaging biomarkers of white matter injury and hippocampal volumetry at baseline and 6 months as potential predictors of neurocognitive decline and differential benefit from HA-WBRT as compared to WBRT.
III. Association of symptom burden and anxiety/depression with neurocognitive function.
IV. Evaluate the potential correlation between the prognostic scoring systems Radiation Therapy Oncology Group (RTOG) recursive partitioning analysis (RPA) and the diagnosis-specific graded prognostic assessment (DS-GPA) and neurocognitive function at baseline and overtime.
After completion of study treatment, patients are followed up at 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WBRT + Memantine | Experimental | Whole brain radiation therapy (WBRT) and memantine |
|
| HA-WBRT/IMRT+ Memantine | Experimental | Whole brain radiation therapy with hippocampal avoidance (HA-WBRT) using intensity modulated radiation therapy (IMRT) and memantine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole brain radiation therapy with hippocampal avoidance | Radiation | Intensity modulated radiation therapy (IMRT) 30 Gy in 10 fractions once per day, 5 days per week for approximately two week; starting within 21 calendar days after randomization. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Neurocognitive Failure | Neurocognitive failure is defined as the first failure, defined as a neurocognitive decline using the reliable change index (RCI) on at least one of the following assessments or parts of : Hopkins Verbal Learning Test - Revised (HVLT-R), Trail Making Test (TMT), or Controlled Oral Word Association (COWA). The HVLT-R has 3 parts that were analyzed separately for decline: Total Recall, Delayed Recall, and Delayed Recognition. The TMT has 2 parts that were analyzed separately: Part A and Part B. Neurocognitive failure rate is estimated using the cumulative incidence method. Analysis was planned to occur after 233 events were reported. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Six-month rates are provided.Analysis was planned to occur after 233 events were reported. | From randomization to last follow-up. Maximum follow-up was 15.6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Hopkins Verbal Learning Test -Revised (HVLT-R) Total Recall Score (Neurocognitive Decline) | The HVLT-R assesses verbal learning and memory. The test involves memorizing a list of 12 nouns for 3 consecutive trials (Total Recall), recalling the 12 targets after a 20-minute delay (Delayed Recall), and then identifying the 12 targets from a list of semantically related or unrelated items (delayed recognition). Raw scores are derived for total recall (sum of the number of targets correctly recalled), delayed recall (sum of the number of targets correctly recalled), and a delayed recognition discrimination index (sum of targets incorrectly identified subtracted from the sum of the number of targets correctly identified). The range of scores for total recall is 0 to 36, for delayed recall is 0 to 12, and -12 to 12 for recognition. A higher score indicates better functioning. Scores are standardized, adjusting for age, education, and gender as necessary, such that mean 0 and standard deviation is 1. Change is calculated as baseline score subtracted from post-baseline score. |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety/Depression Measured Using the EQ-5D-5L | An exploratory analysis, beginning with correlation coefficients, will be used to assess the association of symptom burden and anxiety/depression with neurocognitive function at each time point. The symptom burden items of interest are the "distressed (upset)", "sad", and "mood" items. From the EQ-5D-5L, the depression/anxiety item will be of interest. | Up to 12 months |
Inclusion Criteria:
PRIOR TO STEP 1 REGISTRATION:
PRIOR TO STEP 2 REGISTRATION:
Exclusion Criteria:
Prior external beam radiation therapy to the brain or whole brain radiation therapy
Planned cytotoxic chemotherapy during the WBRT only; patients may have had prior chemotherapy
Radiographic evidence of hydrocephalus or other architectural distortion of the ventricular system, including placement of external ventricular drain or ventriculoperitoneal shunt
Severe, active co-morbidity defined as follows:
Pregnant or lactating women, or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
Prior allergic reaction to memantine (memantine hydrochloride)
Current alcohol or drug abuse (may exacerbate lethargy/dizziness with memantine)
Intractable seizures while on adequate anticonvulsant therapy-more than 1 seizure per month for the past 2 months
Patients with definitive leptomeningeal metastases
Patients with brain metastases from primary germ cell tumors, small cell carcinoma, unknown primary, or lymphoma
Contraindication to magnetic resonance (MR) imaging such as implanted metal devices or foreign bodies
Contraindication to gadolinium contrast administration during MR imaging, such as allergy or insufficient renal function
Current use of (other N-methyl D-aspartate [NMDA] antagonists) amantadine, ketamine, or dextromethorphan
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| Name | Affiliation | Role |
|---|---|---|
| Paul Brown | NRG Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lewis and Faye Manderson Cancer Center | Tuscaloosa | Alabama | 35401 | United States | ||
| Banner MD Anderson Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32058845 | Result | Brown PD, Gondi V, Pugh S, Tome WA, Wefel JS, Armstrong TS, Bovi JA, Robinson C, Konski A, Khuntia D, Grosshans D, Benzinger TLS, Bruner D, Gilbert MR, Roberge D, Kundapur V, Devisetty K, Shah S, Usuki K, Anderson BM, Stea B, Yoon H, Li J, Laack NN, Kruser TJ, Chmura SJ, Shi W, Deshmukh S, Mehta MP, Kachnic LA; for NRG Oncology. Hippocampal Avoidance During Whole-Brain Radiotherapy Plus Memantine for Patients With Brain Metastases: Phase III Trial NRG Oncology CC001. J Clin Oncol. 2020 Apr 1;38(10):1019-1029. doi: 10.1200/JCO.19.02767. Epub 2020 Feb 14. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| NCT02360215 | Individual Participant Data Set | View IPD |
Registered patients who completed required baseline neurocognitive assessments were randomized. Of 561 registered patients, 518 were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | WBRT + Memantine | Whole brain radiation therapy (WBRT) and memantine |
| FG001 | HA-WBRT + Memantine | Whole brain radiation therapy with hippocampal avoidance (HA-WBRT) and memantine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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 | Sep 26, 2017 |
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| Memantine | Drug | Given PO daily during and after radiation therapy for a total of 24 weeks. Week 1: 5 mg in the AM, none in the PM; Week 2: 5 mg in the AM, 5 mg in the PM; Week 3: 10 mg in the AM, 5 mg in the PM; Weeks 4-24: 10 mg in the AM, 10 mg in the PM. Should start the same day as radiation therapy, at latest before the fourth radiation treatment. |
|
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| Whole brain radiation therapy | Radiation | Whole brain radiation therapy (WBRT) 30 Gy in 10 fractions once per day, 5 days per week for approximately 2 weeks |
|
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| Baseline, 2, 4, 6, and 12 months |
| Change From Baseline in the Hopkins Verbal Learning Test -Revised (HVLT-R) Delayed Recall Score (Neurocognitive Decline) | The HVLT-R assesses verbal learning and memory. The test involves memorizing a list of 12 nouns for 3 consecutive trials (Total Recall), recalling the 12 targets after a 20-minute delay (Delayed Recall), and then identifying the 12 targets from a list of semantically related or unrelated items (delayed recognition). Raw scores are derived for total recall (sum of the number of targets correctly recalled), delayed recall (sum of the number of targets correctly recalled), and a delayed recognition discrimination index (sum of targets incorrectly identified subtracted from the sum of the number of targets correctly identified). The range of scores for total recall is 0 to 36, for delayed recall is 0 to 12, and -12 to 12 for recognition. A higher score indicates better functioning. Scores are standardized, adjusting for age, education, and gender as necessary, such that mean 0 and standard deviation is 1. Change is calculated as baseline score subtracted from post-baseline score. | Baseline, 2, 4, 6, and 12 months |
| Change From Baseline in the Hopkins Verbal Learning Test -Revised (HVLT-R) Delayed Recognition (Neurocognitive Decline) | The HVLT-R assesses verbal learning and memory. The test involves memorizing a list of 12 nouns for 3 consecutive trials (Total Recall), recalling the 12 targets after a 20-minute delay (Delayed Recall), and then identifying the 12 targets from a list of semantically related or unrelated items (delayed recognition). Raw scores are derived for total recall (sum of the number of targets correctly recalled), delayed recall (sum of the number of targets correctly recalled), and a delayed recognition discrimination index (sum of targets incorrectly identified subtracted from the sum of the number of targets correctly identified). The range of scores for total recall is 0 to 36, for delayed recall is 0 to 12, and -12 to 12 for recognition. A higher score indicates better functioning. Scores are standardized by expressing the deviation from the mean score of the group in units of standard deviation. Change is calculated as baseline score subtracted from post-baseline score. | Baseline, 2, 4, 6, and 12 months |
| Change From Baseline in the Trail Making Test (TMT) Part A (Neurocognitive Decline) | 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), the targets are all numbers (1, 2, 3, etc.) and the test taker needs to connect them in sequential order; in the second part (Part B), 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 each maze. The range for Part A is 0 to 180 (3 minutes) and for Part B is 0 to 300 (5 minutes). Lower scores indicate better functioning. Scores are standardized, adjusting for age, education, gender as needed, so that mean is 0 and standard deviation is 1. Change is calculated as baseline score subtracted from post-baseline score. | Baseline, 2, 4, 6, and 12 months |
| Change From Baseline in the Trail Making Test (TMT) Part B (Neurocognitive Decline) | 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), the targets are all numbers (1, 2, 3, etc.) and the test taker needs to connect them in sequential order; in the second part (Part B), 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 each maze. The range for Part A is 0 to 180 (3 minutes) and for Part B is 0 to 300 (5 minutes). A lower score indicates better functioning. Scores are standardized by expressing the deviation from the mean score of the group in units of standard deviation. Change is calculated as baseline score subtracted from post-baseline score. | Baseline, 2, 4, 6, and 12 months |
| Change From Baseline in the Controlled Oral Word Association (COWA) Test (Neurocognitive Decline) | 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. Scores are standardized, adjusting for age, education, and gender as necessary, such that mean is 0 and standard deviation is 1. Change is calculated as baseline score subtracted from post-baseline score. | Baseline, 2, 4, 6, and 12 months |
| Change From Baseline in the Clinical Trial Battery Composite (CTB COMP) Score [Neurocognitive Decline] | Clinical Trial Battery Composite score is the arithmetic mean of the HVLT-R (Free Recall, Delayed Recall, Delayed Recognition), TMTA, TMTB, and COWA scores, all of which are standardized, adjusting for age, education, and gender as necessary, such that mean is 0 and standard deviation is 1. A participant must have at least 5 of the 6 scores. A higher composite score indicates better neurocognitive function.Change is calculated as baseline score subtracted from post-baseline score. | Baseline, 2, 4, 6, and 12 months |
| Change in M. D. Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score | The MD Anderson Symptom Inventory for brain tumor (MDASI-BT) is a 28-item multi-symptom patient-reported outcome measure assessing the severity of symptoms experienced by cancer patients and the interference with daily living caused by these symptoms, with 9 items specific to brain tumors. Each item ranges from 0 (best condition) to 10 (worst condition). A subscale score (Symptom Severity) is the average of the subscale items, given that a specified minimum numbers of items were completed. | Baseline, 2, 4, 6, and 12 months |
| Change in M. D. Anderson Symptom Inventory Brain Tumor (MDASI-BT) Interference Score | The MD Anderson Symptom Inventory for brain tumor (MDASI-BT) is a 28-item multi-symptom patient-reported outcome measure assessing the severity of symptoms experienced by cancer patients and the interference with daily living caused by these symptoms, with 9 items specific to brain tumors. Each item ranges from 0 (best condition) to 10 (worst condition). A subscale score (Interference) is the average of the subscale items, given that a specified minimum numbers of items were completed. | Baseline, 2, 4, 6, and 12 months |
| Change in M. D. Anderson Symptom Inventory Brain Tumor (MDASI-BT) Cognitive Factor Score | The MD Anderson Symptom Inventory for brain tumor (MDASI-BT) is a 28-item multi-symptom patient-reported outcome measure assessing the severity of symptoms experienced by cancer patients and the interference with daily living caused by these symptoms, with 9 items specific to brain tumors. Each item ranges from 0 (best condition) to 10 (worst condition). A subscale score (Cognitive Factor) is the average of the subscale items, given that a specified minimum numbers of items were completed. | Baseline, 2, 4, 6, and 12 months |
| Change in M. D. Anderson Symptom Inventory Brain Tumor (MDASI-BT) Neurologic Factor Score | The MD Anderson Symptom Inventory for brain tumor (MDASI-BT) is a 28-item multi-symptom patient-reported outcome measure assessing the severity of symptoms experienced by cancer patients and the interference with daily living caused by these symptoms, with 9 items specific to brain tumors. Each item ranges from 0 (best condition) to 10 (worst condition). A subscale score (Neurologic Factor) is the average of the subscale items, given that a specified minimum numbers of items were completed. | Baseline, 2, 4, 6, and 12 months |
| Change in EQ-5D-5L Index Score at 2 Months | The EQ-5D-5L is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 5 problem levels (1-none to 5-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm scale ranging from 0 for the worst imaginable health state to 100 for best imaginable health state, marked at 10-point intervals. The index score is reported here. | Baseline and 2 months |
| Change in EQ-5D-5L Index Score at 4 Months | The EQ-5D-5L is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 5 problem levels (1-none to 5-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm scale ranging from 0 for the worst imaginable health state to 100 for best imaginable health state, marked at 10-point intervals. The index score is reported here. | Baseline and 4 months |
| Change in EQ-5D-5L Index Score at 6 Months | The EQ-5D-5L is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 5 problem levels (1-none to 5-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm scale ranging from 0 for the worst imaginable health state to 100 for best imaginable health state, marked at 10-point intervals. The index score is reported here. | Baseline and 6 months |
| Change in EQ-5D-5L Index Score at 12 Months | The EQ-5D-5L is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 5 problem levels (1-none to 5-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm scale ranging from 0 for the worst imaginable health state to 100 for best imaginable health state, marked at 10-point intervals. The index score is reported here. | Baseline and 12 months |
| Change in EQ-5D-5L VAS Score at 2 Months | The EQ-5D-5L is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 5 problem levels (1-none to 5-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm scale ranging from 0 for the worst imaginable health state to 100 for best imaginable health state, marked at 10-point intervals. The VAS score is reported here. | Baseline and 2 months |
| Change in EQ-5D-5L VAS Score at 4 Months | The EQ-5D-5L is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 5 problem levels (1-none to 5-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm scale ranging from 0 for the worst imaginable health state to 100 for best imaginable health state, marked at 10-point intervals. The VAS score is reported here. | Baseline and 4 months |
| Change in EQ-5D-5L VAS Score at 6 Months | The EQ-5D-5L is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 5 problem levels (1-none to 5-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm scale ranging from 0 for the worst imaginable health state to 100 for best imaginable health state, marked at 10-point intervals. The VAS score is reported here. | Baseline and 6 months |
| Change in EQ-5D-5L VAS Score at 12 Months | The EQ-5D-5L is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 5 problem levels (1-none to 5-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm scale ranging from 0 for the worst imaginable health state to 100 for best imaginable health state, marked at 10-point intervals. The VAS score is reported here. | Baseline and 12 months |
| Intracranial Progression-Free Survival | Intracranial progression-free survival time is defined as time from registration/randomization to the date of progression in the brain or death from any cause. Intracranial progression-free survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Analysis was planned to occur after 233 primary endpoint events (neurocognitive failure) were reported. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Six-month rates are provided. | From randomization to last follow-up. Analysis was planned to occur after 233 events were reported. Maximum follow-up was 15.6 months. |
| Overall Survival | Overall survival time is defined as time from registration/randomization to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Analysis was planned to occur after 233 primary endpoint events (neurocognitive failure) were reported. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Six-month rates are provided. | From randomization to last follow-up. Maximum follow-up was 15.6 months. |
| Number of Patients With a Grade 3+ Adverse Event (AE) Regardless of Relationship to Treatment | . Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. | From randomization to last follow-up. Analysis was planned to occur after 233 events were reported. Maximum follow-up was 15.6 months. |
| Effect of Radiation Therapy Oncology Group (RTOG) RPA and the Diagnosis-specific Graded Prognostic Assessment (DSGPA) on Neurocognitive Function | Neurocognitive function, as measured by the HVLT-R, COWA, and TMT, will be correlated with both the RTOG RPA and the DS-GPA classification systems. Baseline neurocognitive function for each test will be compared between both RPA classes using either a t-test or Wilcoxon-Mann-Whitney test, depending on the normality of the data. | Up to 12 months |
| Effect of White Matter Injury and Hippocampal Volume on Neurocognitive Function | Evaluated through MRI scans using physician-contoured and auto-contoured scores. Concordance rates will be assessed using Kappa statistics. The auto-contoured scores will be used for the remaining analyses due to the number of physicians reviewing the scans. White matter injury is measured by FLAIR volume change and is a continuous variable. Hippocampal volume is measured as a continuous variable also and both will be covariates considered in the Cox proportional hazards model to assess the impact on time to neurocognitive failure and the longitudinal modeling of neurocognitive function. | Up to 12 months |
| MDASI-BT Mood Variables | The relationship between EQ-5D-5L and MDASI-BT mood variables and neurocognitive function will be assessed. | Up to 12 months |
| Gilbert |
| Arizona |
| 85234 |
| United States |
| Banner University Medical Center - Tucson | Tucson | Arizona | 85719 | United States |
| Providence Saint Joseph Medical Center/Disney Family Cancer Center | Burbank | California | 91505 | United States |
| Mercy San Juan Medical Center | Carmichael | California | 95608 | United States |
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010 | United States |
| UC San Diego Moores Cancer Center | La Jolla | California | 92093 | United States |
| Kaiser Permanente Los Angeles Medical Center | Los Angeles | California | 90027 | United States |
| Los Angeles County-USC Medical Center | Los Angeles | California | 90033 | United States |
| USC / Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
| Kaiser Permanente Oakland-Broadway | Oakland | California | 94611 | United States |
| Stanford Cancer Institute Palo Alto | Palo Alto | California | 94304 | United States |
| Kaiser Permanente-Rancho Cordova Cancer Center | Rancho Cordova | California | 95670 | United States |
| Rohnert Park Cancer Center | Rohnert Park | California | 94928 | 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 |
| Mercy Cancer Center - Sacramento | Sacramento | California | 95816 | United States |
| Sutter Medical Center Sacramento | Sacramento | California | 95816 | United States |
| University of California San Diego | San Diego | California | 92103 | United States |
| California Pacific Medical Center-Pacific Campus | San Francisco | California | 94115 | United States |
| Stanford Cancer Center South Bay | San Jose | California | 95124 | United States |
| Kaiser Permanente Medical Center - Santa Clara | Santa Clara | California | 95051 | United States |
| Kaiser Permanente Cancer Treatment Center | South San Francisco | California | 94080 | United States |
| Sutter Solano Medical Center/Cancer Center | Vallejo | California | 94589 | United States |
| Rocky Mountain Cancer Centers-Boulder | Boulder | Colorado | 80304 | United States |
| Penrose-Saint Francis Healthcare | Colorado Springs | Colorado | 80907 | United States |
| UCHealth Memorial Hospital Central | Colorado Springs | Colorado | 80909 | United States |
| Swedish Medical Center | Englewood | Colorado | 80113 | United States |
| Saint Vincent's Medical Center | Bridgeport | Connecticut | 06606 | 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 |
| UM Sylvester Comprehensive Cancer Center at Deerfield Beach | Deerfield Beach | Florida | 33442 | United States |
| University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida | 33136 | United States |
| UF Cancer Center at Orlando Health | Orlando | Florida | 32806 | United States |
| Cleveland Clinic-Weston | Weston | Florida | 33331 | 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 |
| Emory Saint Joseph's Hospital | Atlanta | Georgia | 30342 | 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 |
| Saint Alphonsus Cancer Care Center-Boise | Boise | Idaho | 83706 | United States |
| Saint Luke's Mountain States Tumor Institute | Boise | Idaho | 83712 | United States |
| Saint Luke's Mountain States Tumor Institute - Meridian | Meridian | Idaho | 83642 | United States |
| Saint Luke's Mountain States Tumor Institute - Nampa | Nampa | Idaho | 83686 | United States |
| Saint Luke's Mountain States Tumor Institute-Twin Falls | Twin Falls | Idaho | 83301 | United States |
| SIH Cancer Institute | Carterville | Illinois | 62918 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| John H Stroger Jr Hospital of Cook County | Chicago | Illinois | 60612 | United States |
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | 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 |
| Methodist Medical Center of Illinois | Peoria | Illinois | 61636 | United States |
| OSF Saint Francis Medical Center | Peoria | Illinois | 61637 | United States |
| Memorial Medical Center | Springfield | Illinois | 62781 | United States |
| Carle Cancer Center | Urbana | Illinois | 61801 | United States |
| Northwestern Medicine Cancer Center Warrenville | Warrenville | Illinois | 60555 | United States |
| Parkview Hospital Randallia | Fort Wayne | Indiana | 46805 | United States |
| Community Cancer Center East | Indianapolis | Indiana | 46219 | United States |
| Community Cancer Center South | Indianapolis | Indiana | 46227 | United States |
| Community Cancer Center North | Indianapolis | Indiana | 46256 | United States |
| Saint Luke's Hospital | Cedar Rapids | Iowa | 52402 | 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 Health Sciences Center | New Orleans | Louisiana | 70112 | United States |
| University of Maryland/Greenebaum Cancer Center | Baltimore | Maryland | 21201 | United States |
| MedStar Union Memorial Hospital | Baltimore | Maryland | 21218 | 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 |
| UM Saint Joseph Medical Center | Towson | Maryland | 21204 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Lahey Hospital and Medical Center | Burlington | Massachusetts | 01805 | United States |
| Lowell General Hospital | Lowell | Massachusetts | 01854 | United States |
| Saint Joseph Mercy Hospital | Ann Arbor | Michigan | 48106 | United States |
| McLaren Cancer Institute-Bay City | Bay City | Michigan | 48706 | United States |
| Henry Ford Cancer Institute-Downriver | Brownstown | Michigan | 48183 | United States |
| Saint Joseph Mercy Chelsea | Chelsea | Michigan | 48118 | United States |
| 21st Century Oncology MHP - Clarkston | Clarkston | Michigan | 48346 | United States |
| McLaren Cancer Institute-Clarkston | Clarkston | Michigan | 48346 | United States |
| Henry Ford Macomb Hospital-Clinton Township | Clinton Township | Michigan | 48038 | United States |
| Wayne State University/Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| 21st Century Oncology MHP - 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 |
| Spectrum Health at Butterworth Campus | 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 |
| Saint Mary Mercy Hospital | Livonia | Michigan | 48154 | United States |
| McLaren Cancer Institute-Macomb | Mount Clemens | Michigan | 48043 | United States |
| McLaren Cancer Institute-Central Michigan | Mount Pleasant | Michigan | 48858 | United States |
| Mercy Health Mercy Campus | Muskegon | Michigan | 49444 | United States |
| McLaren Cancer Institute-Owosso | Owosso | Michigan | 48867 | United States |
| McLaren Cancer Institute-Northern Michigan | Petoskey | Michigan | 49770 | United States |
| Saint Joseph Mercy Oakland | Pontiac | Michigan | 48341 | United States |
| McLaren-Port Huron | Port Huron | Michigan | 48060 | United States |
| Lakeland Medical Center Saint Joseph | Saint Joseph | Michigan | 49085 | United States |
| 21st Century Oncology MHP - 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 |
| Unity Hospital | Fridley | Minnesota | 55432 | 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 | 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 Saint Peters Hospital | City of Saint Peters | Missouri | 63376 | United States |
| Siteman Cancer Center at West County Hospital | Creve Coeur | Missouri | 63141 | United States |
| North Kansas City Hospital | Kansas City | Missouri | 64116 | United States |
| CoxHealth South Hospital | Springfield | Missouri | 65807 | 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 Healthcare- Sletten Cancer Institute | Great Falls | Montana | 59405 | United States |
| Community Medical Hospital | 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 | Lebanon | New Hampshire | 03756 | United States |
| New York-Presbyterian/Brooklyn Methodist Hospital | Brooklyn | New York | 11215 | United States |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York | 10032 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Montefiore Medical Center - Moses Campus | The Bronx | New York | 10467 | United States |
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | United States |
| NHRMC Radiation Oncology - 16th Street | Wilmington | North Carolina | 28401 | United States |
| Sanford Bismarck Medical Center | Bismarck | North Dakota | 58501 | United States |
| Sanford Roger Maris Cancer Center | Fargo | North Dakota | 58122 | United States |
| Summa Akron City Hospital/Cooper Cancer Center | Akron | Ohio | 44304 | United States |
| Cleveland Clinic Akron General | Akron | Ohio | 44307 | 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 |
| Cleveland Clinic Cancer Center Independence | Independence | Ohio | 44131 | 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 |
| 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 |
| Abington Memorial 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 |
| Crozer Regional Cancer Center at Brinton Lake | Glen Mills | Pennsylvania | 19342 | 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 |
| Aria Health-Torresdale Campus | Philadelphia | Pennsylvania | 19114 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | 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 |
| Greenville Health System Cancer Institute-Faris | Greenville | South Carolina | 29605 | United States |
| Greenville Health System 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 |
| Greenville Health System Cancer Institute-Spartanburg | Spartanburg | South Carolina | 29307 | United States |
| Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota | 57117-5134 | United States |
| Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
| University of Texas Medical Branch | Galveston | Texas | 77555-0565 | United States |
| M D 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 |
| Norris Cotton Cancer Center-North | Saint Johnsbury | Vermont | 05819 | United States |
| Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia | 23298 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| North Star Lodge Cancer Center at Yakima Valley Memorial Hospital | Yakima | Washington | 98902 | 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 |
| Mayo Clinic Health System-Eau Claire Clinic | Eau Claire | Wisconsin | 54701 | United States |
| Aurora Cancer Care-Grafton | Grafton | Wisconsin | 53024 | United States |
| Aurora BayCare Medical Center | Green Bay | Wisconsin | 54311 | United States |
| UW 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 Hospital and Clinics | Madison | Wisconsin | 53792 | United States |
| Community Memorial Hospital | Menomonee Falls | Wisconsin | 53051 | United States |
| Ascension Columbia Saint Mary's Water Tower Medical Commons | Milwaukee | Wisconsin | 53211 | 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 |
| Zablocki Veterans Administration Medical Center | Milwaukee | Wisconsin | 53295 | United States |
| Vince Lombardi Cancer Clinic - Oshkosh | Oshkosh | Wisconsin | 54904 | United States |
| Marshfield Clinic Stevens Point Center | 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 |
| Diagnostic and Treatment Center | Weston | Wisconsin | 54476 | United States |
| Aspirus UW Cancer Center | Wisconsin Rapids | Wisconsin | 54494 | United States |
| CHUM - Hopital Notre-Dame | Montreal | Quebec | H2L 4M1 | Canada |
| McGill University Department of Oncology | Montreal | Quebec | H2W 1S6 | 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 |
Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive. |
| All Randomized Participants |
|
| Started Protocol Treatment |
|
| MDASI-BT Symptom Score | M.D. Anderson Symptom Inventory-Brain Module (MDASI-BT) baseline symptom severity subscale completed |
|
| MDASI-BT Intererence Score | MDSAI-BT symptom interference subscale completed at baseline |
|
| MDASI-BT Cognitive Factor Score | MDSAI-BT cognifitive factor subscale completed at baseline |
|
| MDASI-BT Neurologic Factor Score | MDSAI-BT neurologic factor subscale completed at baseline |
|
| HVLT-R Total Recall | Has standardized baseline Hopkins Verbal Learning Test - Revised (HVLT-R) Total Recall score |
|
| HVLT-R Delayed Recall | Has standardized baseline HVLT-R Delayed Recall score |
|
| HVLT-R Recognition | Has standardized baseline HVLT-R Recognition score |
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| Trail Making Test (TMT) Part A | Has standardized baseline TMT Part A score |
|
| TMT Part B | Has standardized baseline TMT Part B score |
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| Controlled Oral Word Association (COWA) | Has standardized baseline COWA score |
|
| Clinical Trial Battery Composite Score | Has standarized baseline Clinical Trial Battery Composite (CTB COMP) score |
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| EQ-5D-5L Index at 2 Months | EQ-5D-5L index score completed at baseline and 2 months from treatment start |
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| EQ-5D-5L Index at 4 Months | EQ-5D-5L index score completed at baseline and 4 months from treatment start |
|
| EQ-5D-5L Index at 6 Months | EQ-5D-5L index score completed at baseline and 6 months from treatment start |
|
| EQ-5D-5L Index at 12 Months | EQ-5D-5L index score completed at baseline and 12 months from treatment start |
|
| EQ-5D-5L VAS at 2 Months | EQ-5D-5L visual analogue scale (VAS) completed at baseline and 2 months from treatment start |
|
| EQ-5D-5L VAS at 4 Months | EQ-5D-5L visual analogue scale (VAS) completed at baseline and 4 months from treatment start |
|
| EQ-5D-5L VAS at 6 Months | EQ-5D-5L visual analogue scale (VAS) completed at baseline and 6 months from treatment start |
|
| EQ-5D-5L VAS at 12 Months | EQ-5D-5L visual analogue scale (VAS) completed at baseline and 12 months from treatment start |
|
| COMPLETED | Subjects contributing data to results are considered to have completed the study. |
|
| NOT COMPLETED |
|
All randomized patients
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | WBRT + Memantine | Whole brain radiation therapy (WBRT) and memantine |
| BG001 | HA-WBRT + Memantine | Whole brain radiation therapy with hippocampal avoidance (HA-WBRT) and memantine |
| 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 |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Primary tumor | Count of Participants | Participants |
| ||||||||||||||||
| Karnofsky Performance Status | 70 = Cares for self; unable to carry on normal activity or to do active work; 80 = Normal activity with effort; some signs or symptoms of disease; 90 = Able to carry on normal activity, minor signs or symptoms of disease; 100 = Normal no complaints; no evidence of disease. | Count of Participants | Participants |
| |||||||||||||||
| Neurologic Function Status | NS = neurologic symptoms; FA = fully active at home/work | Count of Participants | Participants |
| |||||||||||||||
| Recursive Partitioning Analysis (RPA) Class | The Radiation Therapy Oncology Group (RTOG) previously developed three prognostic classes for patients with brain metastases using recursive partitioning analysis (RPA) of a large database. (This study only includes the first two classes.) Class I = Karnofsky Performance Status (KPS) ≥ 70, primary controlled, age < 65, metastasis in brain only. Class II = KPS ≥ 70 and 1 of the following: primary uncontrolled; primary controlled, age ≥ 65; primary controlled, age < 65, metastases in brain & other sites. | Count of Participants | Participants |
| |||||||||||||||
| Prior Radiosurgery | Count of Participants | Participants |
| ||||||||||||||||
| Prior Surgical Resection | Count of Participants | Participants |
| ||||||||||||||||
| Metastases | Count of Participants | Participants |
| ||||||||||||||||
| Education | 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 | Time to Neurocognitive Failure | Neurocognitive failure is defined as the first failure, defined as a neurocognitive decline using the reliable change index (RCI) on at least one of the following assessments or parts of : Hopkins Verbal Learning Test - Revised (HVLT-R), Trail Making Test (TMT), or Controlled Oral Word Association (COWA). The HVLT-R has 3 parts that were analyzed separately for decline: Total Recall, Delayed Recall, and Delayed Recognition. The TMT has 2 parts that were analyzed separately: Part A and Part B. Neurocognitive failure rate is estimated using the cumulative incidence method. Analysis was planned to occur after 233 events were reported. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Six-month rates are provided.Analysis was planned to occur after 233 events were reported. | All randomized participants | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to last follow-up. Maximum follow-up was 15.6 months. |
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| Secondary | Change From Baseline in the Hopkins Verbal Learning Test -Revised (HVLT-R) Total Recall Score (Neurocognitive Decline) | The HVLT-R assesses verbal learning and memory. The test involves memorizing a list of 12 nouns for 3 consecutive trials (Total Recall), recalling the 12 targets after a 20-minute delay (Delayed Recall), and then identifying the 12 targets from a list of semantically related or unrelated items (delayed recognition). Raw scores are derived for total recall (sum of the number of targets correctly recalled), delayed recall (sum of the number of targets correctly recalled), and a delayed recognition discrimination index (sum of targets incorrectly identified subtracted from the sum of the number of targets correctly identified). The range of scores for total recall is 0 to 36, for delayed recall is 0 to 12, and -12 to 12 for recognition. A higher score indicates better functioning. Scores are standardized, adjusting for age, education, and gender as necessary, such that mean 0 and standard deviation is 1. Change is calculated as baseline score subtracted from post-baseline score. | Participants with standardized score at baseline | Posted | Mean | Standard Deviation | units on a scale | Baseline, 2, 4, 6, and 12 months |
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| Secondary | Change From Baseline in the Hopkins Verbal Learning Test -Revised (HVLT-R) Delayed Recall Score (Neurocognitive Decline) | The HVLT-R assesses verbal learning and memory. The test involves memorizing a list of 12 nouns for 3 consecutive trials (Total Recall), recalling the 12 targets after a 20-minute delay (Delayed Recall), and then identifying the 12 targets from a list of semantically related or unrelated items (delayed recognition). Raw scores are derived for total recall (sum of the number of targets correctly recalled), delayed recall (sum of the number of targets correctly recalled), and a delayed recognition discrimination index (sum of targets incorrectly identified subtracted from the sum of the number of targets correctly identified). The range of scores for total recall is 0 to 36, for delayed recall is 0 to 12, and -12 to 12 for recognition. A higher score indicates better functioning. Scores are standardized, adjusting for age, education, and gender as necessary, such that mean 0 and standard deviation is 1. Change is calculated as baseline score subtracted from post-baseline score. | Participants with standardized score at baseline | Posted | Mean | Standard Deviation | units on a scale | Baseline, 2, 4, 6, and 12 months |
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| Secondary | Change From Baseline in the Hopkins Verbal Learning Test -Revised (HVLT-R) Delayed Recognition (Neurocognitive Decline) | The HVLT-R assesses verbal learning and memory. The test involves memorizing a list of 12 nouns for 3 consecutive trials (Total Recall), recalling the 12 targets after a 20-minute delay (Delayed Recall), and then identifying the 12 targets from a list of semantically related or unrelated items (delayed recognition). Raw scores are derived for total recall (sum of the number of targets correctly recalled), delayed recall (sum of the number of targets correctly recalled), and a delayed recognition discrimination index (sum of targets incorrectly identified subtracted from the sum of the number of targets correctly identified). The range of scores for total recall is 0 to 36, for delayed recall is 0 to 12, and -12 to 12 for recognition. A higher score indicates better functioning. Scores are standardized by expressing the deviation from the mean score of the group in units of standard deviation. Change is calculated as baseline score subtracted from post-baseline score. | Participants with baseline data | Posted | Mean | Standard Deviation | units on a scale | Baseline, 2, 4, 6, and 12 months |
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| Secondary | Change From Baseline in the Trail Making Test (TMT) Part A (Neurocognitive Decline) | 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), the targets are all numbers (1, 2, 3, etc.) and the test taker needs to connect them in sequential order; in the second part (Part B), 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 each maze. The range for Part A is 0 to 180 (3 minutes) and for Part B is 0 to 300 (5 minutes). Lower scores indicate better functioning. Scores are standardized, adjusting for age, education, gender as needed, so that mean is 0 and standard deviation is 1. Change is calculated as baseline score subtracted from post-baseline score. | Participants with standardized score at baseline | Posted | Mean | Standard Deviation | units on a scale | Baseline, 2, 4, 6, and 12 months |
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| Secondary | Change From Baseline in the Trail Making Test (TMT) Part B (Neurocognitive Decline) | 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), the targets are all numbers (1, 2, 3, etc.) and the test taker needs to connect them in sequential order; in the second part (Part B), 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 each maze. The range for Part A is 0 to 180 (3 minutes) and for Part B is 0 to 300 (5 minutes). A lower score indicates better functioning. Scores are standardized by expressing the deviation from the mean score of the group in units of standard deviation. Change is calculated as baseline score subtracted from post-baseline score. | Participants with baseline data | Posted | Mean | Standard Deviation | units on a scale | Baseline, 2, 4, 6, and 12 months |
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| Secondary | Change From Baseline in the Controlled Oral Word Association (COWA) Test (Neurocognitive Decline) | 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. Scores are standardized, adjusting for age, education, and gender as necessary, such that mean is 0 and standard deviation is 1. Change is calculated as baseline score subtracted from post-baseline score. | Participants with standardized score at baseline | Posted | Mean | Standard Deviation | units on a scale | Baseline, 2, 4, 6, and 12 months |
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| Secondary | Change From Baseline in the Clinical Trial Battery Composite (CTB COMP) Score [Neurocognitive Decline] | Clinical Trial Battery Composite score is the arithmetic mean of the HVLT-R (Free Recall, Delayed Recall, Delayed Recognition), TMTA, TMTB, and COWA scores, all of which are standardized, adjusting for age, education, and gender as necessary, such that mean is 0 and standard deviation is 1. A participant must have at least 5 of the 6 scores. A higher composite score indicates better neurocognitive function.Change is calculated as baseline score subtracted from post-baseline score. | Participants with standardized score at baseline | Posted | Mean | Standard Deviation | units on a scale | Baseline, 2, 4, 6, and 12 months |
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| Secondary | Change in M. D. Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score | The MD Anderson Symptom Inventory for brain tumor (MDASI-BT) is a 28-item multi-symptom patient-reported outcome measure assessing the severity of symptoms experienced by cancer patients and the interference with daily living caused by these symptoms, with 9 items specific to brain tumors. Each item ranges from 0 (best condition) to 10 (worst condition). A subscale score (Symptom Severity) is the average of the subscale items, given that a specified minimum numbers of items were completed. | Participants with baseline data | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2, 4, 6, and 12 months |
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| Secondary | Change in M. D. Anderson Symptom Inventory Brain Tumor (MDASI-BT) Interference Score | The MD Anderson Symptom Inventory for brain tumor (MDASI-BT) is a 28-item multi-symptom patient-reported outcome measure assessing the severity of symptoms experienced by cancer patients and the interference with daily living caused by these symptoms, with 9 items specific to brain tumors. Each item ranges from 0 (best condition) to 10 (worst condition). A subscale score (Interference) is the average of the subscale items, given that a specified minimum numbers of items were completed. | Participants with baseline data | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2, 4, 6, and 12 months |
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| Secondary | Change in M. D. Anderson Symptom Inventory Brain Tumor (MDASI-BT) Cognitive Factor Score | The MD Anderson Symptom Inventory for brain tumor (MDASI-BT) is a 28-item multi-symptom patient-reported outcome measure assessing the severity of symptoms experienced by cancer patients and the interference with daily living caused by these symptoms, with 9 items specific to brain tumors. Each item ranges from 0 (best condition) to 10 (worst condition). A subscale score (Cognitive Factor) is the average of the subscale items, given that a specified minimum numbers of items were completed. | Participants with baseline data | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2, 4, 6, and 12 months |
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| Secondary | Change in M. D. Anderson Symptom Inventory Brain Tumor (MDASI-BT) Neurologic Factor Score | The MD Anderson Symptom Inventory for brain tumor (MDASI-BT) is a 28-item multi-symptom patient-reported outcome measure assessing the severity of symptoms experienced by cancer patients and the interference with daily living caused by these symptoms, with 9 items specific to brain tumors. Each item ranges from 0 (best condition) to 10 (worst condition). A subscale score (Neurologic Factor) is the average of the subscale items, given that a specified minimum numbers of items were completed. | Participants with baseline data | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2, 4, 6, and 12 months |
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| Secondary | Change in EQ-5D-5L Index Score at 2 Months | The EQ-5D-5L is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 5 problem levels (1-none to 5-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm scale ranging from 0 for the worst imaginable health state to 100 for best imaginable health state, marked at 10-point intervals. The index score is reported here. | Participants with baseline and 2-month scores | Posted | Mean | Standard Deviation | score on a scale | Baseline and 2 months |
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| Secondary | Change in EQ-5D-5L Index Score at 4 Months | The EQ-5D-5L is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 5 problem levels (1-none to 5-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm scale ranging from 0 for the worst imaginable health state to 100 for best imaginable health state, marked at 10-point intervals. The index score is reported here. | Participants with baseline and 4-month scores | Posted | Mean | Standard Deviation | score on a scale | Baseline and 4 months |
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| Secondary | Change in EQ-5D-5L Index Score at 6 Months | The EQ-5D-5L is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 5 problem levels (1-none to 5-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm scale ranging from 0 for the worst imaginable health state to 100 for best imaginable health state, marked at 10-point intervals. The index score is reported here. | Participants with baseline and 4-month scores | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 months |
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| Secondary | Change in EQ-5D-5L Index Score at 12 Months | The EQ-5D-5L is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 5 problem levels (1-none to 5-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm scale ranging from 0 for the worst imaginable health state to 100 for best imaginable health state, marked at 10-point intervals. The index score is reported here. | Participants with baseline and 12-month scores | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 months |
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| Secondary | Change in EQ-5D-5L VAS Score at 2 Months | The EQ-5D-5L is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 5 problem levels (1-none to 5-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm scale ranging from 0 for the worst imaginable health state to 100 for best imaginable health state, marked at 10-point intervals. The VAS score is reported here. | Participants with baseline and 2-month scores | Posted | Mean | Standard Deviation | score on a scale | Baseline and 2 months |
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| Secondary | Change in EQ-5D-5L VAS Score at 4 Months | The EQ-5D-5L is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 5 problem levels (1-none to 5-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm scale ranging from 0 for the worst imaginable health state to 100 for best imaginable health state, marked at 10-point intervals. The VAS score is reported here. | Participants with baseline and 4-month scores | Posted | Mean | Standard Deviation | score on a scale | Baseline and 4 months |
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| Secondary | Change in EQ-5D-5L VAS Score at 6 Months | The EQ-5D-5L is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 5 problem levels (1-none to 5-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm scale ranging from 0 for the worst imaginable health state to 100 for best imaginable health state, marked at 10-point intervals. The VAS score is reported here. | Participants with baseline and 6-month scores | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 months |
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| Secondary | Change in EQ-5D-5L VAS Score at 12 Months | The EQ-5D-5L is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 5 problem levels (1-none to 5-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm scale ranging from 0 for the worst imaginable health state to 100 for best imaginable health state, marked at 10-point intervals. The VAS score is reported here. | Participants with baseline and 6-month scores | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 months |
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| Secondary | Intracranial Progression-Free Survival | Intracranial progression-free survival time is defined as time from registration/randomization to the date of progression in the brain or death from any cause. Intracranial progression-free survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Analysis was planned to occur after 233 primary endpoint events (neurocognitive failure) were reported. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Six-month rates are provided. | All randomized participants | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to last follow-up. Analysis was planned to occur after 233 events were reported. Maximum follow-up was 15.6 months. |
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| Secondary | Overall Survival | Overall survival time is defined as time from registration/randomization to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Analysis was planned to occur after 233 primary endpoint events (neurocognitive failure) were reported. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Six-month rates are provided. | All randomized participants | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to last follow-up. Maximum follow-up was 15.6 months. |
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| Secondary | Number of Patients With a Grade 3+ Adverse Event (AE) Regardless of Relationship to Treatment | . Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. | Randomized participants who started protocol treatment | Posted | Count of Participants | Participants | From randomization to last follow-up. Analysis was planned to occur after 233 events were reported. Maximum follow-up was 15.6 months. |
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| Other Pre-specified | Anxiety/Depression Measured Using the EQ-5D-5L | An exploratory analysis, beginning with correlation coefficients, will be used to assess the association of symptom burden and anxiety/depression with neurocognitive function at each time point. The symptom burden items of interest are the "distressed (upset)", "sad", and "mood" items. From the EQ-5D-5L, the depression/anxiety item will be of interest. | Not Posted | Up to 12 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Effect of Radiation Therapy Oncology Group (RTOG) RPA and the Diagnosis-specific Graded Prognostic Assessment (DSGPA) on Neurocognitive Function | Neurocognitive function, as measured by the HVLT-R, COWA, and TMT, will be correlated with both the RTOG RPA and the DS-GPA classification systems. Baseline neurocognitive function for each test will be compared between both RPA classes using either a t-test or Wilcoxon-Mann-Whitney test, depending on the normality of the data. | Not Posted | Up to 12 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Effect of White Matter Injury and Hippocampal Volume on Neurocognitive Function | Evaluated through MRI scans using physician-contoured and auto-contoured scores. Concordance rates will be assessed using Kappa statistics. The auto-contoured scores will be used for the remaining analyses due to the number of physicians reviewing the scans. White matter injury is measured by FLAIR volume change and is a continuous variable. Hippocampal volume is measured as a continuous variable also and both will be covariates considered in the Cox proportional hazards model to assess the impact on time to neurocognitive failure and the longitudinal modeling of neurocognitive function. | Not Posted | Up to 12 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | MDASI-BT Mood Variables | The relationship between EQ-5D-5L and MDASI-BT mood variables and neurocognitive function will be assessed. | Not Posted | Up to 12 months | Participants |
From randomization to last follow-up. Maximum follow-up was 15.6 months.
Not provided
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 | WBRT + Memantine | Whole brain radiation therapy (WBRT) and memantine | 138 | 232 | 98 | 232 | 214 | 232 |
| EG001 | HA-WBRT + Memantin | Whole brain radiation therapy with hippocampal avoidance (HA-WBRT) and memantine | 135 | 223 | 106 | 223 | 201 | 223 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Cardiac disorders - Other | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pericardial tamponade | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Cushingoid | Endocrine disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Endocrine disorders - Other | Endocrine disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Blurred vision | Eye disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Bloating | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Esophageal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Esophageal obstruction | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Gastrointestinal disorders - Other | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Lower gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pancreatic hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Small intestinal perforation | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Chills | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Death NOS | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fever | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Flu like symptoms | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| General disorders and administration site conditions - Other | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Infusion related reaction | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Localized edema | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Multi-organ failure | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Sudden death NOS | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Bile duct stenosis | Hepatobiliary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Gallbladder obstruction | Hepatobiliary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hepatic pain | Hepatobiliary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hepatobiliary disorders - Other | Hepatobiliary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Allergic reaction | Immune system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Abdominal infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Bone infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Bronchial infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Catheter related infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Encephalitis infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Endocarditis infective | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Infections and infestations - Other | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Mucosal infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Peritoneal infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Small intestine infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| INR increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Investigations - Other | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Metabolism and nutrition disorders - Other | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Chest wall pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Muscle weakness left-sided | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Muscle weakness right-sided | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Muscle weakness upper limb | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Musculoskeletal and connective tissue disorder - Other | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Non-systematic Assessment |
| |
| Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Non-systematic Assessment |
| |
| Ataxia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Cognitive disturbance | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Edema cerebral | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Intracranial hemorrhage | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Ischemia cerebrovascular | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Memory impairment | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Movements involuntary | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Nervous system disorders - Other | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Paresthesia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Stroke | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Delirium | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hallucinations | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Psychiatric disorders - Other | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Renal and urinary disorders - Other | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Renal calculi | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary urgency | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Bronchopulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Skin and subcutaneous tissue disorders - Other | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Skin ulceration | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Surgical and medical procedures - Other | Surgical and medical procedures | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Peripheral ischemia | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Vascular disorders - Other | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hearing impaired | Ear and labyrinth disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Blurred vision | Eye disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Mucosal infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dermatitis radiation | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Memory impairment | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Nervous system disorders - Other | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Paresthesia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
Must obtain prior Sponsor approval.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wendy Seiferheld | NRG Oncology | 215-574-3208 | seiferheldw@nrgoncology.org |
| Aug 21, 2019 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 26, 2017 | Aug 21, 2019 | ICF_001.pdf |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D050397 | Radiotherapy, Intensity-Modulated |
| D008559 | Memantine |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D000547 | Amantadine |
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
Not provided
Not provided
| 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 |
|
| Breast |
|
| Colon |
|
| Esophagus |
|
| Gastroesophageal Junction |
|
| Kidney |
|
| Lung |
|
| Ovary |
|
| Skin |
|
| Analcanal |
|
| Pancreas |
|
| Other |
|
| 80 |
|
| 90 |
|
| 100 |
|
| Minor neurologic symptoms, FA without assistance |
|
| Moderate NS, FA but requires assistance |
|
| Moderate NS, less than FA and requires assistance |
|
| Unknown |
|
| Not Reported |
|
| Class II |
|
| Yes |
|
| Yes |
|
| Brain and Other Sites |
|
| Grade school |
|
| Not high education graduate |
|
| High school graduate (including equivalency) |
|
| Some college or associate degree |
|
| Bachelor's Degree |
|
| Master's Degree |
|
| Doctoral degree or professional degree |
|
| Not reported |
|
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| Participants |
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