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Trial record 12 of 55 for:    "Anaplastic oligoastrocytoma"

Radiation Therapy Combined With Chemotherapy in Treating Patients With Anaplastic Astrocytoma or Mixed Gliomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00004259
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : November 13, 2017
Last Update Posted : June 14, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
North Central Cancer Treatment Group
Eastern Cooperative Oncology Group
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Brain and Central Nervous System Tumors
Interventions Drug: BCNU 80mg/m2
Drug: TMZ 200mg/m2
Radiation: radiation therapy
Drug: CCNU
Drug: BCNU 150mg/m2
Drug: BCNU 200mg/m2
Drug: TMZ 150mg/m2 six 6-week cycles
Drug: TMZ 150mg/m2 six 8-week cycles
Enrollment 230
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Radiation Therapy + Temozolomide (TMZ) RT + BCNU/CCNU Pilot Arm #1: RT+TMZ+BCNU Pilot Arm #2: RT+TMZ+BCNU
Hide Arm/Group Description Radiation therapy (RT) for 6 weeks concurrent with and followed by TMZ 200mg/m2 for twelve 28-day cycles Radiation therapy for 6 weeks concurrent with and followed by BCNU 80mg/m2 or CCNU 130 mg/m2 for six 8-week cycles Radiation therapy for 6 weeks concurrent with and followed by BCNU 200mg/m2 and TMZ 150mg/m2 six 6-week cycles Radiation therapy for 6 weeks concurrent with and followed by BCNU 150mg/m2 and TMZ 150mg/m2 six 8-week cycles
Period Title: Overall Study
Started 98 103 15 14
Completed 97 99 15 14
Not Completed 1 4 0 0
Reason Not Completed
Protocol Violation             1             2             0             0
Withdrawal by Subject             0             2             0             0
Arm/Group Title Radiation Therapy + Temozolomide (TMZ) RT + BCNU/CCNU Pilot Arm #1: RT+TMZ+BCNU Pilot Arm #2: RT+TMZ+BCNU Total
Hide Arm/Group Description Radiation therapy (RT) for 6 weeks concurrent with and followed by TMZ 200mg/m2 for twelve 28-day cycles Radiation therapy for 6 weeks concurrent with and followed by BCNU 80mg/m2 or CCNU 130 mg/m2 for six 8-week cycles Radiation therapy for 6 weeks concurrent with and followed by BCNU 200mg/m2 and TMZ 150mg/m2 six 6-week cycles Radiation therapy for 6 weeks concurrent with and followed by BCNU 150mg/m2 and TMZ 150mg/m2 six 8-week cycles Total of all reporting groups
Overall Number of Baseline Participants 97 99 15 14 225
Hide Baseline Analysis Population Description
Eligible patients
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 97 participants 99 participants 15 participants 14 participants 225 participants
42
(18 to 73)
43
(19 to 80)
48
(26 to 80)
41
(25 to 74)
43
(18 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 99 participants 15 participants 14 participants 225 participants
Female
42
  43.3%
47
  47.5%
5
  33.3%
6
  42.9%
100
  44.4%
Male
55
  56.7%
52
  52.5%
10
  66.7%
8
  57.1%
125
  55.6%
1.Primary Outcome
Title (Phase III) Overall Survival (OS)
Hide Description Survival time is defined as time from randomization 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. Per the protocol, the pilot arms were not included in the Phase III analyses.
Time Frame From randomization to date of death. Patients are followed until death. Analysis occurs after 155 deaths have been reported, estimated at 5.5 years from the study opening.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible randomized patients
Arm/Group Title Radiation Therapy + Temozolomide (TMZ) RT + BCNU/CCNU
Hide Arm/Group Description:
Radiation therapy (RT) for 6 weeks concurrent with and followed by TMZ 200mg/m2 for twelve 28-day cycles
Radiation therapy for 6 weeks concurrent with and followed by BCNU 80mg/m2 or CCNU 130 mg/m2 for six 8-week cycles
Overall Number of Participants Analyzed 97 99
Median (95% Confidence Interval)
Unit of Measure: years
3.9
(3.0 to 7.0)
3.8
(2.2 to 7.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Radiation Therapy + Temozolomide (TMZ), RT + BCNU/CCNU
Comments The hypothesized median survival time was 36 months for the RT+BCNU/CCNU arm and 54 months for the RT+TMZ arm, corresponding to a hazard ratio (HR) of 0.67. A sample size of 216 evaluable patients per arm would provide 90% power with a one-sided significance level of 0.05. The final analysis was planned after 155 deaths were observed. Interim efficacy analyses were planned after 52 and 104 deaths, with an interim futility analysis planned at 128 deaths.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.36
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.67 to 1.32
Estimation Comments [Not Specified]
2.Primary Outcome
Title (Phase I) Number of Subjects With Dose Limiting Toxicities (DLT) on the Two Pilot Arms
Hide Description Adverse events were graded using CTCAE v2.0. Grade refers to the severity of the adverse event (AE). The CTCAE v2.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Dose limiting toxicity (DLT) was defined as grade 3+ pulmonary toxicity, grade 4+ thrombocytopenia (< 25,000 for 5 days), neutropenia (< 500/microl for 7 days), or neutropenia of any duration with fever requiring hospital admission after one dose reduction of 50% in BCNU. A 20% rate of grade 3+ pulmonary toxicities or a 40% rate of grade 4+ thrombocytopenia and neutropenia was considered unacceptable for a treatment arm combining RT, TMZ, and BCNU.
Time Frame From start of treatment to 3 months
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Hide Analysis Population Description
Eligible patients who started study treatment on Pilot Arms 1 and 2
Arm/Group Title Pilot Arm #1: RT+TMZ+BCNU Pilot Arm #2: RT+TMZ+BCNU
Hide Arm/Group Description:
Radiation therapy for 6 weeks concurrent with and followed by BCNU 200mg/m2 and TMZ 150mg/m2 six 6-week cycles
Radiation therapy for 6 weeks concurrent with and followed by BCNU 150mg/m2 and TMZ 150mg/m2 six 8-week cycles
Overall Number of Participants Analyzed 15 13
Measure Type: Count of Participants
Unit of Measure: Participants
Subjects with Pulmonary DLT
1
   6.7%
0
   0.0%
Subjects with Hematologic DLT
4
  26.7%
3
  23.1%
3.Secondary Outcome
Title (Phase III) Time to Tumor Progression (TTP)
Hide Description Three-year rate is reported. Progression is defined as a radiographic increase in size of the lesion by > 25%, recurrence of the study lesion, or the development of new lesions, confirmed by imaging. Time to tumor progression was estimated using the cumulative incidence function (CIF) on tumor progression, with death as a competing risk. Per the protocol, the pilot arms were not included in the Phase III analyses.
Time Frame From randomization to date of death. Patients are followed until death. Analysis occurs after 155 deaths have been reported, estimated at 5.5 years from the study opening.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible randomized patients
Arm/Group Title Radiation Therapy + Temozolomide (TMZ) RT + BCNU/CCNU
Hide Arm/Group Description:
Radiation therapy (RT) for 6 weeks concurrent with and followed by TMZ 200mg/m2 for twelve 28-day cycles
Radiation therapy for 6 weeks concurrent with and followed by BCNU 80mg/m2 or CCNU 130 mg/m2 for six 8-week cycles
Overall Number of Participants Analyzed 97 99
Median (95% Confidence Interval)
Unit of Measure: months
45.4
(35.2 to 55.0)
54.7
(44.2 to 63.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Radiation Therapy + Temozolomide (TMZ), RT + BCNU/CCNU
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.46
Comments 2-sided
Method Gray's test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.80
Confidence Interval (2-Sided) 95%
0.55 to 1.16
Estimation Comments Reference level = RT + BCNU/CCNU
4.Secondary Outcome
Title (Phase III) Number of Patients With Grade 3 or Higher Toxicity
Hide Description Adverse events were graded using CTCAE v2.0. Grade refers to the severity of the AE. The CTCAE v2.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. The number of patients with grade or higher toxicity was calculated overall and for non-hematologic toxicity only. Per the protocol, the pilot arms were not included in the Phase III analyses.
Time Frame From randomization to date of death. Patients are followed until death. Analysis occurs after 155 deaths have been reported, estimated at 5.5 years from the study opening.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible randomized patients who started study treatment
Arm/Group Title Radiation Therapy + Temozolomide (TMZ) RT + BCNU/CCNU
Hide Arm/Group Description:
Radiation therapy (RT) for 6 weeks concurrent with and followed by TMZ 200mg/m2 for twelve 28-day cycles
Radiation therapy for 6 weeks concurrent with and followed by BCNU 80mg/m2 or CCNU 130 mg/m2 for six 8-week cycles
Overall Number of Participants Analyzed 96 99
Measure Type: Number
Unit of Measure: participants
Overall toxicity 46 75
Non-hematologic toxicity 31 34
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Radiation Therapy + Temozolomide (TMZ), RT + BCNU/CCNU
Comments Overall toxicity
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments 2-sided
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Radiation Therapy + Temozolomide (TMZ), RT + BCNU/CCNU
Comments Non-hematologic toxicity
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.76
Comments 2-sided
Method Chi-squared
Comments [Not Specified]
5.Secondary Outcome
Title (Phase III) Correlation of Molecular Analyses With Overall Survival and Time to Tumor Progression
Hide Description [Not Specified]
Time Frame From randomization to date of death. Patients are followed until death. Analysis occurs after 155 deaths have been reported, estimated at 5.5 years from the study opening.
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description Eligible subjects who started study treatment and have toxicity information are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
 
Arm/Group Title Radiation Therapy + Temozolomide (TMZ) RT + BCNU/CCNU Pilot Arm #1: RT+TMZ+BCNU Pilot Arm #2: RT+TMZ+BCNU
Hide Arm/Group Description Radiation therapy (RT) for 6 weeks concurrent with and followed by TMZ 200mg/m2 for twelve 28-day cycles Radiation therapy for 6 weeks concurrent with and followed by BCNU 80mg/m2 or CCNU 130 mg/m2 for six 8-week cycles Radiation therapy for 6 weeks concurrent with and followed by BCNU 200mg/m2 and TMZ 150mg/m2 six 6-week cycles Radiation therapy for 6 weeks concurrent with and followed by BCNU 150mg/m2 and TMZ 150mg/m2 six 8-week cycles
All-Cause Mortality
Radiation Therapy + Temozolomide (TMZ) RT + BCNU/CCNU Pilot Arm #1: RT+TMZ+BCNU Pilot Arm #2: RT+TMZ+BCNU
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Radiation Therapy + Temozolomide (TMZ) RT + BCNU/CCNU Pilot Arm #1: RT+TMZ+BCNU Pilot Arm #2: RT+TMZ+BCNU
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   43/96 (44.79%)   72/99 (72.73%)   8/15 (53.33%)   11/13 (84.62%) 
Blood and lymphatic system disorders         
Febrile neutropenia * 1  1/96 (1.04%)  4/99 (4.04%)  1/15 (6.67%)  0/13 (0.00%) 
Hemoglobin decreased * 1  1/96 (1.04%)  14/99 (14.14%)  3/15 (20.00%)  0/13 (0.00%) 
Packed red blood cell transfusion * 1  2/96 (2.08%)  2/99 (2.02%)  2/15 (13.33%)  0/13 (0.00%) 
Platelet transfusion * 1  3/96 (3.13%)  10/99 (10.10%)  2/15 (13.33%)  2/13 (15.38%) 
Cardiac disorders         
Edema NOS * 1  0/96 (0.00%)  2/99 (2.02%)  0/15 (0.00%)  0/13 (0.00%) 
Myocardial ischaemia * 1  1/96 (1.04%)  1/99 (1.01%)  0/15 (0.00%)  0/13 (0.00%) 
Ear and labyrinth disorders         
Otitis externa (exc boil of meatus) NOS * 1  0/96 (0.00%)  1/99 (1.01%)  0/15 (0.00%)  0/13 (0.00%) 
Otitis media serous NOS * 1  0/96 (0.00%)  1/99 (1.01%)  0/15 (0.00%)  0/13 (0.00%) 
Eye disorders         
Late RT Toxicity:Eye NOS  2  1/96 (1.04%)  0/99 (0.00%)  0/15 (0.00%)  0/13 (0.00%) 
Gastrointestinal disorders         
Caecitis * 1  1/96 (1.04%)  0/99 (0.00%)  0/15 (0.00%)  0/13 (0.00%) 
Diarrhea NOS * 1  1/96 (1.04%)  1/99 (1.01%)  0/15 (0.00%)  0/13 (0.00%) 
Nausea * 1  1/96 (1.04%)  2/99 (2.02%)  0/15 (0.00%)  0/13 (0.00%) 
Vomiting NOS * 1  1/96 (1.04%)  2/99 (2.02%)  0/15 (0.00%)  0/13 (0.00%) 
General disorders         
Constitutional symptons-Other * 1  0/96 (0.00%)  0/99 (0.00%)  0/15 (0.00%)  1/13 (7.69%) 
Late RT Toxicity:Other NOS  2  0/96 (0.00%)  0/99 (0.00%)  0/15 (0.00%)  1/13 (7.69%) 
Pain-other * 1  1/96 (1.04%)  0/99 (0.00%)  0/15 (0.00%)  0/13 (0.00%) 
Infections and infestations         
Infection NOS * 1  0/96 (0.00%)  2/99 (2.02%)  1/15 (6.67%)  0/13 (0.00%) 
Infection with grade 3 or 4 neutropenia * 1  2/96 (2.08%)  4/99 (4.04%)  2/15 (13.33%)  2/13 (15.38%) 
Infection, Other * 1  0/96 (0.00%)  0/99 (0.00%)  1/15 (6.67%)  0/13 (0.00%) 
Investigations         
Alanine aminotransferase increased * 1  2/96 (2.08%)  0/99 (0.00%)  0/15 (0.00%)  0/13 (0.00%) 
Bilirbin-graft versus host disease * 1  0/96 (0.00%)  0/99 (0.00%)  1/15 (6.67%)  0/13 (0.00%) 
Gamma-glutamyltransferase increased * 1  1/96 (1.04%)  1/99 (1.01%)  0/15 (0.00%)  0/13 (0.00%) 
Leukopenia NOS * 1  4/96 (4.17%)  9/99 (9.09%)  3/15 (20.00%)  4/13 (30.77%) 
Lymphopenia * 1  3/96 (3.13%)  7/99 (7.07%)  0/15 (0.00%)  0/13 (0.00%) 
Neutropenia * 1  13/96 (13.54%)  43/99 (43.43%)  6/15 (40.00%)  5/13 (38.46%) 
Neutrophils/granulocytes for BMT * 1  1/96 (1.04%)  0/99 (0.00%)  0/15 (0.00%)  0/13 (0.00%) 
Platelet count decreased * 1  16/96 (16.67%)  43/99 (43.43%)  6/15 (40.00%)  9/13 (69.23%) 
Pulmonary function test NOS decreased * 1  0/96 (0.00%)  2/99 (2.02%)  0/15 (0.00%)  0/13 (0.00%) 
Weight decreased * 1  0/96 (0.00%)  0/99 (0.00%)  0/15 (0.00%)  1/13 (7.69%) 
Metabolism and nutrition disorders         
Acidosis NOS * 1  0/96 (0.00%)  1/99 (1.01%)  0/15 (0.00%)  0/13 (0.00%) 
Dehydration * 1  1/96 (1.04%)  1/99 (1.01%)  0/15 (0.00%)  0/13 (0.00%) 
Hyperglycemia NOS * 1  1/96 (1.04%)  1/99 (1.01%)  1/15 (6.67%)  0/13 (0.00%) 
Hyperkalemia * 1  0/96 (0.00%)  1/99 (1.01%)  0/15 (0.00%)  0/13 (0.00%) 
Hyperuricemia * 1  1/96 (1.04%)  0/99 (0.00%)  0/15 (0.00%)  0/13 (0.00%) 
Hypokalemia * 1  1/96 (1.04%)  1/99 (1.01%)  0/15 (0.00%)  0/13 (0.00%) 
Hyponatremia * 1  1/96 (1.04%)  2/99 (2.02%)  0/15 (0.00%)  0/13 (0.00%) 
Musculoskeletal and connective tissue disorders         
Bone pain * 1  0/96 (0.00%)  1/99 (1.01%)  0/15 (0.00%)  0/13 (0.00%) 
Nervous system disorders         
Amnesia NEC * 1  1/96 (1.04%)  1/99 (1.01%)  0/15 (0.00%)  0/13 (0.00%) 
Ataxia NEC * 1  1/96 (1.04%)  1/99 (1.01%)  0/15 (0.00%)  0/13 (0.00%) 
Cerebral ischaemia * 1  0/96 (0.00%)  1/99 (1.01%)  0/15 (0.00%)  0/13 (0.00%) 
Convulsions NOS * 1  3/96 (3.13%)  4/99 (4.04%)  0/15 (0.00%)  1/13 (7.69%) 
Depressed level of consciousness * 1  0/96 (0.00%)  1/99 (1.01%)  0/15 (0.00%)  1/13 (7.69%) 
Dizziness (exc vertigo) * 1  1/96 (1.04%)  0/99 (0.00%)  0/15 (0.00%)  1/13 (7.69%) 
Headache NOS * 1  4/96 (4.17%)  4/99 (4.04%)  0/15 (0.00%)  0/13 (0.00%) 
Hemorrhagic stroke * 1  2/96 (2.08%)  0/99 (0.00%)  0/15 (0.00%)  0/13 (0.00%) 
Late RT Toxicity:Brain NOS  2  1/96 (1.04%)  1/99 (1.01%)  0/15 (0.00%)  0/13 (0.00%) 
Peripheral motor neuropathy * 1  6/96 (6.25%)  2/99 (2.02%)  0/15 (0.00%)  1/13 (7.69%) 
Speech disorder NEC * 1  1/96 (1.04%)  2/99 (2.02%)  0/15 (0.00%)  0/13 (0.00%) 
Syncope * 1  2/96 (2.08%)  0/99 (0.00%)  0/15 (0.00%)  0/13 (0.00%) 
Vertigo NEC * 1  0/96 (0.00%)  0/99 (0.00%)  1/15 (6.67%)  0/13 (0.00%) 
Psychiatric disorders         
Depression NEC * 1  0/96 (0.00%)  1/99 (1.01%)  0/15 (0.00%)  0/13 (0.00%) 
Euphoric mood * 1  1/96 (1.04%)  0/99 (0.00%)  0/15 (0.00%)  0/13 (0.00%) 
Personality change * 1  1/96 (1.04%)  0/99 (0.00%)  0/15 (0.00%)  0/13 (0.00%) 
Renal and urinary disorders         
Renal failure NOS * 1  0/96 (0.00%)  1/99 (1.01%)  0/15 (0.00%)  0/13 (0.00%) 
Urinary incontinence * 1  0/96 (0.00%)  1/99 (1.01%)  0/15 (0.00%)  0/13 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Adult respiratory distress syndrome * 1  0/96 (0.00%)  1/99 (1.01%)  0/15 (0.00%)  0/13 (0.00%) 
Dyspnea NOS * 1  0/96 (0.00%)  3/99 (3.03%)  1/15 (6.67%)  0/13 (0.00%) 
Hypoxia * 1  0/96 (0.00%)  1/99 (1.01%)  0/15 (0.00%)  0/13 (0.00%) 
Pulmonary-other * 1  0/96 (0.00%)  2/99 (2.02%)  0/15 (0.00%)  0/13 (0.00%) 
Skin and subcutaneous tissue disorders         
Culture wound positive * 1  1/96 (1.04%)  0/99 (0.00%)  0/15 (0.00%)  0/13 (0.00%) 
Dermatitis exfoliative NOS * 1  2/96 (2.08%)  0/99 (0.00%)  1/15 (6.67%)  0/13 (0.00%) 
Erythema multiforme * 1  1/96 (1.04%)  0/99 (0.00%)  0/15 (0.00%)  0/13 (0.00%) 
Petechiae * 1  1/96 (1.04%)  0/99 (0.00%)  0/15 (0.00%)  0/13 (0.00%) 
Vascular disorders         
Hypertension NOS * 1  1/96 (1.04%)  0/99 (0.00%)  0/15 (0.00%)  0/13 (0.00%) 
Thrombosis NOS * 1  2/96 (2.08%)  2/99 (2.02%)  1/15 (6.67%)  2/13 (15.38%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (2.0)
2
Term from vocabulary, RTOG/EORTC Late Tox.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Radiation Therapy + Temozolomide (TMZ) RT + BCNU/CCNU Pilot Arm #1: RT+TMZ+BCNU Pilot Arm #2: RT+TMZ+BCNU
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   94/96 (97.92%)   95/99 (95.96%)   14/15 (93.33%)   13/13 (100.00%) 
Blood and lymphatic system disorders         
Hematologic-Other * 1  4/96 (4.17%)  5/99 (5.05%)  0/15 (0.00%)  1/13 (7.69%) 
Hemoglobin decreased * 1  32/96 (33.33%)  59/99 (59.60%)  13/15 (86.67%)  13/13 (100.00%) 
Cardiac disorders         
Edema NOS * 1  3/96 (3.13%)  6/99 (6.06%)  0/15 (0.00%)  2/13 (15.38%) 
Ear and labyrinth disorders         
Hearing impaired * 1  5/96 (5.21%)  9/99 (9.09%)  0/15 (0.00%)  1/13 (7.69%) 
Hearing-Other * 1  8/96 (8.33%)  6/99 (6.06%)  0/15 (0.00%)  1/13 (7.69%) 
Eye disorders         
Vision blurred * 1  12/96 (12.50%)  10/99 (10.10%)  2/15 (13.33%)  1/13 (7.69%) 
Gastrointestinal disorders         
Constipation * 1  37/96 (38.54%)  8/99 (8.08%)  3/15 (20.00%)  0/13 (0.00%) 
Diarrhea NOS * 1  13/96 (13.54%)  12/99 (12.12%)  1/15 (6.67%)  1/13 (7.69%) 
Dry mouth * 1  5/96 (5.21%)  5/99 (5.05%)  1/15 (6.67%)  0/13 (0.00%) 
Dyspepsia * 1  9/96 (9.38%)  5/99 (5.05%)  0/15 (0.00%)  1/13 (7.69%) 
Esophagitis NOS * 1  5/96 (5.21%)  1/99 (1.01%)  0/15 (0.00%)  0/13 (0.00%) 
Nausea * 1  75/96 (78.13%)  42/99 (42.42%)  7/15 (46.67%)  7/13 (53.85%) 
Stomatitis * 1  9/96 (9.38%)  3/99 (3.03%)  1/15 (6.67%)  0/13 (0.00%) 
Vomiting NOS * 1  34/96 (35.42%)  16/99 (16.16%)  3/15 (20.00%)  1/13 (7.69%) 
General disorders         
Fatigue * 1  78/96 (81.25%)  73/99 (73.74%)  9/15 (60.00%)  9/13 (69.23%) 
Late RT Toxicity:Other NOS  2  17/96 (17.71%)  17/99 (17.17%)  4/15 (26.67%)  3/13 (23.08%) 
Pain-other * 1  9/96 (9.38%)  11/99 (11.11%)  0/15 (0.00%)  2/13 (15.38%) 
Pyrexia * 1  2/96 (2.08%)  6/99 (6.06%)  0/15 (0.00%)  0/13 (0.00%) 
Infections and infestations         
Infection NOS * 1  10/96 (10.42%)  6/99 (6.06%)  0/15 (0.00%)  0/13 (0.00%) 
Injury, poisoning and procedural complications         
Late RT Toxicity:Skin(within RT field)NOS  2  13/96 (13.54%)  11/99 (11.11%)  3/15 (20.00%)  1/13 (7.69%) 
Investigations         
Alanine aminotransferase increased * 1  22/96 (22.92%)  21/99 (21.21%)  3/15 (20.00%)  2/13 (15.38%) 
Aspartate aminotransferase increased * 1  21/96 (21.88%)  18/99 (18.18%)  5/15 (33.33%)  1/13 (7.69%) 
Blood alkaline phosphatase NOS increased * 1  13/96 (13.54%)  18/99 (18.18%)  2/15 (13.33%)  2/13 (15.38%) 
Leukopenia NOS * 1  37/96 (38.54%)  70/99 (70.71%)  12/15 (80.00%)  10/13 (76.92%) 
Lymphopenia * 1  15/96 (15.63%)  13/99 (13.13%)  0/15 (0.00%)  0/13 (0.00%) 
Metabolic-Other * 1  5/96 (5.21%)  4/99 (4.04%)  0/15 (0.00%)  1/13 (7.69%) 
Neutropenia * 1  17/96 (17.71%)  45/99 (45.45%)  4/15 (26.67%)  2/13 (15.38%) 
Platelet count decreased * 1  44/96 (45.83%)  63/99 (63.64%)  9/15 (60.00%)  11/13 (84.62%) 
Pulmonary function test NOS decreased * 1  0/96 (0.00%)  9/99 (9.09%)  5/15 (33.33%)  3/13 (23.08%) 
Weight decreased * 1  10/96 (10.42%)  10/99 (10.10%)  2/15 (13.33%)  3/13 (23.08%) 
Metabolism and nutrition disorders         
Anorexia * 1  31/96 (32.29%)  23/99 (23.23%)  6/15 (40.00%)  3/13 (23.08%) 
Hyperglycemia NOS * 1  9/96 (9.38%)  7/99 (7.07%)  1/15 (6.67%)  1/13 (7.69%) 
Hypocalcemia * 1  7/96 (7.29%)  7/99 (7.07%)  4/15 (26.67%)  2/13 (15.38%) 
Hypokalemia * 1  6/96 (6.25%)  5/99 (5.05%)  3/15 (20.00%)  2/13 (15.38%) 
Hyponatremia * 1  3/96 (3.13%)  6/99 (6.06%)  4/15 (26.67%)  1/13 (7.69%) 
Musculoskeletal and connective tissue disorders         
Arthralgia * 1  5/96 (5.21%)  2/99 (2.02%)  1/15 (6.67%)  1/13 (7.69%) 
Muscle weakness NOS * 1  12/96 (12.50%)  5/99 (5.05%)  1/15 (6.67%)  3/13 (23.08%) 
Myalgia * 1  6/96 (6.25%)  4/99 (4.04%)  0/15 (0.00%)  0/13 (0.00%) 
Nervous system disorders         
Amnesia NEC * 1  14/96 (14.58%)  13/99 (13.13%)  2/15 (13.33%)  2/13 (15.38%) 
Ataxia NEC * 1  4/96 (4.17%)  5/99 (5.05%)  0/15 (0.00%)  2/13 (15.38%) 
Convulsions NOS * 1  13/96 (13.54%)  13/99 (13.13%)  2/15 (13.33%)  3/13 (23.08%) 
Dizziness (exc vertigo) * 1  16/96 (16.67%)  13/99 (13.13%)  0/15 (0.00%)  2/13 (15.38%) 
Headache NOS * 1  45/96 (46.88%)  31/99 (31.31%)  2/15 (13.33%)  7/13 (53.85%) 
Late RT Toxicity:Brain NOS  2  11/96 (11.46%)  14/99 (14.14%)  3/15 (20.00%)  4/13 (30.77%) 
Learning disorder NOS * 1  5/96 (5.21%)  3/99 (3.03%)  0/15 (0.00%)  0/13 (0.00%) 
Peripheral motor neuropathy * 1  11/96 (11.46%)  7/99 (7.07%)  1/15 (6.67%)  2/13 (15.38%) 
Peripheral sensory neuropathy * 1  14/96 (14.58%)  9/99 (9.09%)  1/15 (6.67%)  1/13 (7.69%) 
Speech disorder NEC * 1  8/96 (8.33%)  4/99 (4.04%)  0/15 (0.00%)  0/13 (0.00%) 
Taste disturbance * 1  14/96 (14.58%)  13/99 (13.13%)  3/15 (20.00%)  1/13 (7.69%) 
Tremor NEC * 1  7/96 (7.29%)  4/99 (4.04%)  1/15 (6.67%)  2/13 (15.38%) 
Psychiatric disorders         
Anxiety NEC * 1  12/96 (12.50%)  9/99 (9.09%)  1/15 (6.67%)  1/13 (7.69%) 
Confusion * 1  2/96 (2.08%)  10/99 (10.10%)  2/15 (13.33%)  1/13 (7.69%) 
Depression NEC * 1  12/96 (12.50%)  6/99 (6.06%)  1/15 (6.67%)  2/13 (15.38%) 
Insomnia NEC * 1  18/96 (18.75%)  8/99 (8.08%)  0/15 (0.00%)  1/13 (7.69%) 
Respiratory, thoracic and mediastinal disorders         
Cough * 1  9/96 (9.38%)  7/99 (7.07%)  0/15 (0.00%)  1/13 (7.69%) 
Dyspnea NOS * 1  7/96 (7.29%)  13/99 (13.13%)  0/15 (0.00%)  5/13 (38.46%) 
Skin and subcutaneous tissue disorders         
Alopecia * 1  56/96 (58.33%)  58/99 (58.59%)  6/15 (40.00%)  9/13 (69.23%) 
Dermatitis exfoliative NOS * 1  13/96 (13.54%)  7/99 (7.07%)  2/15 (13.33%)  0/13 (0.00%) 
Dermatitis radiation NOS * 1  17/96 (17.71%)  16/99 (16.16%)  2/15 (13.33%)  1/13 (7.69%) 
Injection site reaction NOS * 1  0/96 (0.00%)  8/99 (8.08%)  0/15 (0.00%)  2/13 (15.38%) 
Skin-Other * 1  6/96 (6.25%)  2/99 (2.02%)  0/15 (0.00%)  0/13 (0.00%) 
Vascular disorders         
Phlebitis superficial * 1  0/96 (0.00%)  5/99 (5.05%)  0/15 (0.00%)  0/13 (0.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (2.0)
2
Term from vocabulary, RTOG/EORTC Late Tox.
Accrual to the TMZ BCNU arm required an acceptable toxicity profile from a pilot arm. Treatment cessation/reduction for toxicity caused the combination arm to be dropped. Per the protocol, the pilot arms were not included in the Phase III analyses.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
Results Point of Contact
Name/Title: Wendy Seiferheld, M.S.
Organization: NRG Oncology
Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00004259     History of Changes
Other Study ID Numbers: RTOG-9813
CDR0000067512
ECOG-R9813
NCCTG-RTOG-9813
First Submitted: January 28, 2000
First Posted: January 27, 2003
Results First Submitted: May 25, 2017
Results First Posted: November 13, 2017
Last Update Posted: June 14, 2018