Trial · NCT00004259
Radiation Therapy Combined With Chemotherapy in Treating Patients With Anaplastic Astrocytoma or Mixed Gliomas
NCT00004259, Phase 3, Completed, Radiation Therapy Oncology Group; results first posted 2017-11-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Radiation Therapy Combined With Chemotherapy in Treating Patients With Anaplastic Astrocytoma or Mixed Gliomas. Trials, record NCT00004259. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00004259
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Radiation Therapy Combined With Chemotherapy in Treating Patients With Anaplastic Astrocytoma or Mixed Gliomas
- NCT number
- NCT00004259
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 230 participants, actual
- Lead sponsor
- Radiation Therapy Oncology Group
- Conditions
- Brain and Central Nervous System Tumors
- Interventions
- BCNU 80mg/m2, TMZ 200mg/m2, radiation therapy, CCNU, BCNU 150mg/m2, BCNU 200mg/m2, TMZ 150mg/m2 six 6-week cycles, TMZ 150mg/m2 six 8-week cycles
- First posted
- 2003-01-27
- Last updated
- 2019-09-12
- Results first posted
- 2017-11-13
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | (Phase III) Overall Survival (OS) | 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. | 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. |
| Primary | (Phase I) Number of Subjects With Dose Limiting Toxicities (DLT) on the Two Pilot Arms | From start of treatment to 3 months | 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. |
| Secondary | (Phase III) Time to Tumor Progression (TTP) | 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. | 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. |
| Secondary | (Phase III) Number of Patients With Grade 3 or Higher Toxicity | 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. | 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. |
| Secondary | (Phase III) Survival Time by MGMT Status | 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. | 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. Tumor tissue samples were analyzed for methylation status of methyl guanine methyl transferase (MGMT), classified as methylated vs. unmethylated. |
| Secondary | (Phase III) Progression-free Survival by MGMT Status | 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. | 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. Progression-free survival time is defined as time from randomization to date of progression 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. Tumor tissue samples were analyzed for methylation status of methyl guanine methyl transferase (MGMT), classified as methylated vs. unmethylated. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | (Phase III) Overall Survival (OS) | 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. | Eligible randomized patients | years | MEDIAN |
| PRIMARY | (Phase I) Number of Subjects With Dose Limiting Toxicities (DLT) on the Two Pilot Arms | From start of treatment to 3 months | Eligible patients who started study treatment on Pilot Arms 1 and 2 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | (Phase III) Time to Tumor Progression (TTP) | 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. | Eligible randomized patients | months | MEDIAN |
| SECONDARY | (Phase III) Number of Patients With Grade 3 or Higher Toxicity | 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. | Eligible randomized patients who started study treatment | participants | NUMBER |
| SECONDARY | (Phase III) Survival Time by MGMT Status | 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. | Eligible patients with MGMT data | years | MEDIAN |
| SECONDARY | (Phase III) Progression-free Survival by MGMT Status | 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. | Eligible patients with MGMT data | years | MEDIAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| (Phase III) Overall Survival (OS) | Radiation Therapy + Temozolomide (TMZ) | 3.9 | 95% Confidence Interval 3.0 to 7.0 | years | |
| (Phase III) Overall Survival (OS) | RT + BCNU/CCNU | 3.8 | 95% Confidence Interval 2.2 to 7.0 | years | |
| (Phase I) Number of Subjects With Dose Limiting Toxicities (DLT) on the Two Pilot Arms | Pilot Arm #1: RT+TMZ+BCNU | Subjects with Pulmonary DLT | 1 | Participants | |
| (Phase I) Number of Subjects With Dose Limiting Toxicities (DLT) on the Two Pilot Arms | Pilot Arm #2: RT+TMZ+BCNU | Subjects with Pulmonary DLT | 0 | Participants | |
| (Phase I) Number of Subjects With Dose Limiting Toxicities (DLT) on the Two Pilot Arms | Pilot Arm #1: RT+TMZ+BCNU | Subjects with Hematologic DLT | 4 | Participants | |
| (Phase I) Number of Subjects With Dose Limiting Toxicities (DLT) on the Two Pilot Arms | Pilot Arm #2: RT+TMZ+BCNU | Subjects with Hematologic DLT | 3 | Participants | |
| (Phase III) Time to Tumor Progression (TTP) | Radiation Therapy + Temozolomide (TMZ) | 45.4 | 95% Confidence Interval 35.2 to 55.0 | months | |
| (Phase III) Time to Tumor Progression (TTP) | RT + BCNU/CCNU | 54.7 | 95% Confidence Interval 44.2 to 63.9 | months | |
| (Phase III) Number of Patients With Grade 3 or Higher Toxicity | Radiation Therapy + Temozolomide (TMZ) | Overall toxicity | 46 | participants | |
| (Phase III) Number of Patients With Grade 3 or Higher Toxicity | RT + BCNU/CCNU | Overall toxicity | 75 | participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Radiation Therapy + Temozolomide (TMZ) | 98 | |
| Overall Study | STARTED | RT + BCNU/CCNU | 103 | |
| Overall Study | STARTED | Pilot Arm #1: RT+TMZ+BCNU | 15 | |
| Overall Study | STARTED | Pilot Arm #2: RT+TMZ+BCNU | 14 | |
| Overall Study | COMPLETED | Radiation Therapy + Temozolomide (TMZ) | 97 | |
| Overall Study | COMPLETED | RT + BCNU/CCNU | 99 | |
| Overall Study | COMPLETED | Pilot Arm #1: RT+TMZ+BCNU | 15 | |
| Overall Study | COMPLETED | Pilot Arm #2: RT+TMZ+BCNU | 14 | |
| Overall Study | NOT COMPLETED | Radiation Therapy + Temozolomide (TMZ) | 1 | |
| Overall Study | NOT COMPLETED | RT + BCNU/CCNU | 4 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events508
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hematologic-Other | Blood and lymphatic system disorders | Radiation Therapy + Temozolomide (TMZ) | 4 | 96 | |
| other | Hematologic-Other | Blood and lymphatic system disorders | RT + BCNU/CCNU | 5 | 99 | |
| other | Hematologic-Other | Blood and lymphatic system disorders | Pilot Arm #1: RT+TMZ+BCNU | 0 | 15 | |
| other | Hematologic-Other | Blood and lymphatic system disorders | Pilot Arm #2: RT+TMZ+BCNU | 1 | 13 | |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Radiation Therapy + Temozolomide (TMZ) | 32 | 96 | |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | RT + BCNU/CCNU | 59 | 99 | |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Pilot Arm #1: RT+TMZ+BCNU | 13 | 15 | |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Pilot Arm #2: RT+TMZ+BCNU | 13 | 13 | |
| other | Edema NOS | Cardiac disorders | Radiation Therapy + Temozolomide (TMZ) | 3 | 96 | |
| other | Edema NOS | Cardiac disorders | RT + BCNU/CCNU | 6 | 99 |
1 to 10 of 508Source ClinicalTrials.gov
See all 508 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Radiation Therapy + Temozolomide (TMZ) | ||
| Total, all-cause mortality | RT + BCNU/CCNU | ||
| Total, all-cause mortality | Pilot Arm #1: RT+TMZ+BCNU | ||
| Total, all-cause mortality | Pilot Arm #2: RT+TMZ+BCNU | ||
| Total, other adverse events | Radiation Therapy + Temozolomide (TMZ) | 94 | 96 |
| Total, other adverse events | RT + BCNU/CCNU | 95 | 99 |
| Total, other adverse events | Pilot Arm #1: RT+TMZ+BCNU | 14 | 15 |
| Total, other adverse events | Pilot Arm #2: RT+TMZ+BCNU | 13 | 13 |
| Total, serious adverse events | Radiation Therapy + Temozolomide (TMZ) | 43 | 96 |
| Total, serious adverse events | RT + BCNU/CCNU | 72 | 99 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 15234047 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00004259
GET https://conductscience.org/api/trials/v1/NCT00004259/events?page=2