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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000434849 | |||
| NCI-2009-00723 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| NRG Oncology | OTHER |
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RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving temozolomide together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving temozolomide together with radiation therapy works in treating patients with low-grade gliomas.
OBJECTIVES:
OUTLINE: This is a non-randomized, multicenter study.
Patients receive oral temozolomide once daily on days 1-42 and undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40, one hour before RT weekdays, in the evening weekends. Beginning 28 days after completion of chemoradiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, 6 months, 12 months.
After completion of study treatment, patients are followed at 4 months, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 135 patients will be accrued for this study within 44 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Temozolomide + Radiation Therapy (RT) | Experimental | Daily temozolomide plus concurrent radiotherapy followed by temozolomide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temozolomide | Drug | Concurrent chemoradiotherapy temozolomide given 75 mg/m^2 daily during radiotherapy for 6 weeks. Post-Radiation Temozolomide given 150 mg/m2 daily on days 1-5 every 28 days with cycle one beginning 28 days post-radiotherapy. In the absence of grade 3 or 4 adverse events, a single dose escalation to 200 mg/m2/day could be attempted for cycle 2 and, if tolerated, that dose should continue for all subsequent cycles. Cycles were repeated every 28 days (+/- 2 days) for a total of 12 cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival Rate at 3 Years | Survival time is defined as time from registration to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. This analysis was planned to occur when all patients had been potentially followed for at least 3 years. | Registration to 3 years |
| Progression-free Survival | Progressive Disease (PD) is defined as 25% or > increase in the cross-sectional area of enhancing or non-enhancing tumor on consecutive MRI scans, or any new area(s) of tumor. Under exceptional circumstances, disease progression may be declared in the absence of an increase in tumor size based on "clinical deterioration" including the need for increasing doses of steroid and/or a worsening Karnofsky Performance Status(KPS) / Neurologic Function Score(NFS). Progression-free survival time is defined as time from registration to date of progressive disease or death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Median survival time is reported. | From registration to last follow-up, up to 7.1 years. Analysis occurs after all patients have been on study for at least 3 years. |
| Survival and Progression-free Survival by O(6)-Methylguanine-DNA Methyltransferase (MGMT) Methylation Status | Survival time is defined as time from registration to date of death from any cause. Progressive Disease (PD) is defined as 25% or > increase in the cross-sectional area of enhancing or non-enhancing tumor on consecutive MRI scans, or any new area(s) of tumor. Under exceptional circumstances, disease progression may be declared in the absence of an increase in tumor size based on "clinical deterioration" including the need for increasing doses of steroid and/or a worsening Karnofsky Performance Status(KPS) / Neurologic Function Score(NFS). Survival and progression-free survival are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. | Registration to 3 years |
| Quality of Life as Measured by the Functional Assessment of Cancer Therapy Scale With Brain Module (FACT-BR) |
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DISEASE CHARACTERISTICS:
Histologically confirmed* supratentorial glioma of 1 of the following histologies:
Unifocal or multifocal disease
World Health Organization (WHO) grade II disease
Neurofibromatosis allowed
Surgical biopsy or resection for tumor tissue sampling required within the past 12 weeks
Must have ≥ 3 of the following risk factors:
No other low-grade glioma histologies, including any of the following:
No high-grade glioma, including any of the following:
No tumors in any non-supratentorial location, including any of the following:
No evidence of disease progression to spinal meninges or noncontiguous cranial meninges (i.e., leptomeningeal gliomatosis) by MRI of the spine or cerebrospinal fluid (CSF) cytology
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Barbara J. Fisher, MD | London Health Sciences Centre | Principal Investigator |
| David R. Macdonald, MD, FRCPC | London Health Sciences Centre | Study Chair |
| Glenn J. Lesser, MD | Wake Forest University Health Sciences | Study Chair |
| Stephen W. Coons, MD | St. Joseph's Hospital and Medical Center, Phoenix | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Oncology Services Foundation | Phoenix | Arizona | 85013 | United States | ||
| USC/Norris Comprehensive Cancer Center and Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29955793 | Derived | Bell EH, Zhang P, Fisher BJ, Macdonald DR, McElroy JP, Lesser GJ, Fleming J, Chakraborty AR, Liu Z, Becker AP, Fabian D, Aldape KD, Ashby LS, Werner-Wasik M, Walker EM, Bahary JP, Kwok Y, Yu HM, Laack NN, Schultz CJ, Gray HJ, Robins HI, Mehta MP, Chakravarti A. Association of MGMT Promoter Methylation Status With Survival Outcomes in Patients With High-Risk Glioma Treated With Radiotherapy and Temozolomide: An Analysis From the NRG Oncology/RTOG 0424 Trial. JAMA Oncol. 2018 Oct 1;4(10):1405-1409. doi: 10.1001/jamaoncol.2018.1977. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Temozolomide + Radiation Therapy (RT) | Daily temozolomide plus concurrent radiotherapy followed by temozolomide |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Radiation therapy | Radiation | One treatment of 1.8 Gy given daily, 5 days per week (over 6 weeks) for a total dose of 54.0 Gy. |
|
Functional Assessment of Cancer Therapy Scale with brain module (FACT-BR): a 50-question self-report questionnaire contains the following domains (scales): Physical well-being (7 questions totalling 0-28), social/family well-being (7 questions totalling 0-28), emotional well-being (6 questions totalling 0-24), functional well-being (7 questions totalling 0-28) and brain cancer subscale which contains concerns relevant to patients with brain tumors (19 questions totalling 0-76). Each question has a value 0-4. For some questions a higher indicates better outcome and others are the opposite. The former are summed as is, the latter are reversed in value before adding, such that each domain ranges from 0 to 4 multiplied by the number of questions in the domain, with 0 indicating worst and the highest possible value indicating best outcome. The FACT-Br total (0-184) is obtained by adding all domains together if the overall question response rate is greater than 80%. |
| Baseline, 6 months, and 12 months. |
| Neurocognitive Function | Hopkins Verbal Learning Test (HVLT) is a test measuring learning memory retrieval, and memory consolidation processes.; Controlled Oral Word Association Test (COWAT) is a test of phonemic verbal fluency. The patient produces as many words as possible in 1 min. (each) for a specific letter (C, F, L or P, R, W).; Trail Making Test (TMT) is a measure of visuospatial scanning, attention, sequencing, and speed in Part A (TMT A) and executive function in Part B (TMT B). Patients must "connect the dots" either in a numbered sequence or alternating letters and numbers. Difference between pre-treatment baseline and follow-up assessment scores determined by the reliable change (RC) index, using a 90% confidence interval to designate statistically significant change. | Baseline, 6 months, and 12 months. |
| Los Angeles |
| California |
| 90089-9181 |
| United States |
| CCOP - Christiana Care Health Services | Newark | Delaware | 19713 | United States |
| University of Florida Shands Cancer Center | Gainesville | Florida | 32610-0232 | United States |
| Baptist Cancer Institute - Jacksonville | Jacksonville | Florida | 32207 | United States |
| Integrated Community Oncology Network at Southside Cancer Center | Jacksonville | Florida | 32207 | United States |
| Mayo Clinic - Jacksonville | Jacksonville | Florida | 32224 | United States |
| Baptist Medical Center South | Jacksonville | Florida | 32258 | United States |
| Integrated Community Oncology Network | Jacksonville Beach | Florida | 32250 | United States |
| Integrated Community Oncology Network - Orange Park | Orange Park | Florida | 32073 | United States |
| Florida Cancer Center - Palatka | Palatka | Florida | 32177 | United States |
| Flagler Cancer Center | Saint Augustine | Florida | 32086 | United States |
| University of Chicago Cancer Research Center | Chicago | Illinois | 60637-1470 | United States |
| DeCesaris Cancer Institute at Anne Arundel Medical Center | Annapolis | Maryland | 21401 | United States |
| Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109-0942 | United States |
| Josephine Ford Cancer Center at Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007-3731 | United States |
| Sparrow Regional Cancer Center | Lansing | Michigan | 48912-1811 | United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| CCOP - Kansas City | Kansas City | Missouri | 64131 | United States |
| Methodist Estabrook Cancer Center | Omaha | Nebraska | 68114 | United States |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756-0002 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | United States |
| Mission Hospitals - Memorial Campus | Asheville | North Carolina | 28801 | United States |
| Summa Center for Cancer Care at Akron City Hospital | Akron | Ohio | 44309-2090 | United States |
| Aultman Cancer Center at Aultman Hospital | Canton | Ohio | 44710-1799 | United States |
| Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | 44195 | United States |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus | Ohio | 43210-1240 | United States |
| Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford | Salem | Ohio | 44460 | United States |
| Cancer Treatment Center | Wooster | Ohio | 44691 | United States |
| Rosenfeld Cancer Center at Abington Memorial Hospital | Abington | Pennsylvania | 19001 | United States |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033-0850 | United States |
| Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia | Pennsylvania | 19107-5541 | United States |
| CCOP - Upstate Carolina | Spartanburg | South Carolina | 29303 | United States |
| Rapid City Regional Hospital | Rapid City | South Dakota | 57701 | United States |
| Jon and Karen Huntsman Cancer Center at Intermountain Medical Center | Murray | Utah | 84157 | United States |
| Dixie Regional Medical Center - East Campus | St. George | Utah | 84770 | United States |
| University Cancer Center at University of Washington Medical Center | Seattle | Washington | 98195-6043 | United States |
| Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin | 54301-3526 | United States |
| St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin | 54307-3508 | United States |
| Gundersen Lutheran Center for Cancer and Blood | La Crosse | Wisconsin | 54601 | United States |
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison | Wisconsin | 53792-6164 | United States |
| Bay Area Cancer Care Center at Bay Area Medical Center | Marinette | Wisconsin | 54143 | United States |
| Medical College of Wisconsin Cancer Center | Milwaukee | Wisconsin | 53226 | United States |
| Hopital Notre-Dame du CHUM | Montreal | Quebec | H2L 4M1 | Canada |
| McGill Cancer Centre at McGill University | Montreal | Quebec | H2W 1S6 | Canada |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Eligible patients
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| ID | Title | Description |
|---|---|---|
| BG000 | Temozolomide + Radiation Therapy (RT) | Daily temozolomide plus concurrent radiotherapy followed by temozolomide |
| 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 |
|
| 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 | Overall Survival Rate at 3 Years | Survival time is defined as time from registration to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. This analysis was planned to occur when all patients had been potentially followed for at least 3 years. | Eligible patients | Posted | Number | 95% Confidence Interval | percentage of participants | Registration to 3 years |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Progression-free Survival | Progressive Disease (PD) is defined as 25% or > increase in the cross-sectional area of enhancing or non-enhancing tumor on consecutive MRI scans, or any new area(s) of tumor. Under exceptional circumstances, disease progression may be declared in the absence of an increase in tumor size based on "clinical deterioration" including the need for increasing doses of steroid and/or a worsening Karnofsky Performance Status(KPS) / Neurologic Function Score(NFS). Progression-free survival time is defined as time from registration to date of progressive disease or death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Median survival time is reported. | Eligible patients | Posted | Median | 95% Confidence Interval | years | From registration to last follow-up, up to 7.1 years. Analysis occurs after all patients have been on study for at least 3 years. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Survival and Progression-free Survival by O(6)-Methylguanine-DNA Methyltransferase (MGMT) Methylation Status | Survival time is defined as time from registration to date of death from any cause. Progressive Disease (PD) is defined as 25% or > increase in the cross-sectional area of enhancing or non-enhancing tumor on consecutive MRI scans, or any new area(s) of tumor. Under exceptional circumstances, disease progression may be declared in the absence of an increase in tumor size based on "clinical deterioration" including the need for increasing doses of steroid and/or a worsening Karnofsky Performance Status(KPS) / Neurologic Function Score(NFS). Survival and progression-free survival are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. | Eligible patients with O(6)-methylguanine-DNA methyltransferase (MGMT) status | Posted | Median | 95% Confidence Interval | years | Registration to 3 years |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Quality of Life as Measured by the Functional Assessment of Cancer Therapy Scale With Brain Module (FACT-BR) | Functional Assessment of Cancer Therapy Scale with brain module (FACT-BR): a 50-question self-report questionnaire contains the following domains (scales): Physical well-being (7 questions totalling 0-28), social/family well-being (7 questions totalling 0-28), emotional well-being (6 questions totalling 0-24), functional well-being (7 questions totalling 0-28) and brain cancer subscale which contains concerns relevant to patients with brain tumors (19 questions totalling 0-76). Each question has a value 0-4. For some questions a higher indicates better outcome and others are the opposite. The former are summed as is, the latter are reversed in value before adding, such that each domain ranges from 0 to 4 multiplied by the number of questions in the domain, with 0 indicating worst and the highest possible value indicating best outcome. The FACT-Br total (0-184) is obtained by adding all domains together if the overall question response rate is greater than 80%. | Eligible patients entered after QOL component amendment and alive at 6 and 12 months for respective post-baseline endpoints. | Posted | Median | Full Range | units on a scale | Baseline, 6 months, and 12 months. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Neurocognitive Function | Hopkins Verbal Learning Test (HVLT) is a test measuring learning memory retrieval, and memory consolidation processes.; Controlled Oral Word Association Test (COWAT) is a test of phonemic verbal fluency. The patient produces as many words as possible in 1 min. (each) for a specific letter (C, F, L or P, R, W).; Trail Making Test (TMT) is a measure of visuospatial scanning, attention, sequencing, and speed in Part A (TMT A) and executive function in Part B (TMT B). Patients must "connect the dots" either in a numbered sequence or alternating letters and numbers. Difference between pre-treatment baseline and follow-up assessment scores determined by the reliable change (RC) index, using a 90% confidence interval to designate statistically significant change. | Eligible patients entered after QOL component amendment with baseline score and alive at 6 and 12 months for respective timepoint. | Posted | Number | participants | Baseline, 6 months, and 12 months. |
|
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Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Temozolomide + Radiation Therapy (RT) | Daily temozolomide plus concurrent radiotherapy followed by temozolomide | 37 | 129 | 129 | 129 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood/bone marrow - Other: | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Atrial tachycardia | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hearing impaired | Ear and labyrinth disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dry eye NOS | Eye disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Abdominal pain NOS | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Small intestinal stricture NOS | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Vomiting NOS | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Disease progression NOS | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain - Other: | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypersensitivity NOS | Immune system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection - Other: | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infectous meningitis | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pneumonia NOS | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Urinary tract infection NOS | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fracture NOS | Injury, poisoning and procedural complications | CTCAE (3.0) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Leukopenia NOS | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Lymphopenia | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Neutrophil count | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyperglycaemia NOS | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Muscle weakness, generalized or specific area (not due to neuropathy): Extremity-lower | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Secondary Malignancy - possibly related to cancer treatment | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Convulsions NOS | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhagic stroke | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Memory impairment | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Personality change | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Uterine hemorrhage | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dermatitis exfoliative NOS | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypertension NOS | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hearing impaired | Ear and labyrinth disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Ocular/visual - Other: | Eye disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Abdominal pain NOS | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Diarrhoea NOS | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Gastrointestinal - Other: | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Vomiting NOS | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Edema: limb: | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain - Other: | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dermatitis radiation NOS | Injury, poisoning and procedural complications | CTCAE (3.0) | Non-systematic Assessment |
| |
| Radiation recall syndrome | Injury, poisoning and procedural complications | CTCAE (3.0) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Leukopenia NOS | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Lymphopenia | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Metabolic/laboratory - Other: | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Neutrophil count | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyperglycaemia NOS | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypoglycemia NOS | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Muscle weakness, generalized or specific area (not due to neuropathy): Extremity-lower | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Ataxia | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Convulsions NOS | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Memory impairment | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Neurology - Other: | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Speech disorder | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Personality change | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dermatitis exfoliative NOS | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dermatology/skin - Other: | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
Quality of life endpoint was added via an amendment while study was in progress.
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wendy Seiferheld, M.S. | NRG Oncology | seiferheldw@nrgoncology.org |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D001254 | Astrocytoma |
| D009837 | Oligodendroglioma |
| D005910 | Glioma |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077204 | Temozolomide |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013812 | Therapeutics |
Not provided
Not provided
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
Daily temozolomide plus concurrent radiotherapy followed by temozolomide
| OG002 | Temozolomide + Radiation Therapy (RT) at 12 Months | Daily temozolomide plus concurrent radiotherapy followed by temozolomide |
|
|
| Units | Counts |
|---|
| Participants |
|
|