Trial · NCT00304031
Radiation Therapy (RT) and Temozolomide (TMZ) in Treating Patients With Newly Diagnosed Glioblastoma or Gliosarcoma
NCT00304031, Phase 3, Completed, Radiation Therapy Oncology Group; results first posted 2014-04-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Radiation Therapy (RT) and Temozolomide (TMZ) in Treating Patients With Newly Diagnosed Glioblastoma or Gliosarcoma. Trials, record NCT00304031. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00304031
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Radiation Therapy (RT) and Temozolomide (TMZ) in Treating Patients With Newly Diagnosed Glioblastoma or Gliosarcoma
- NCT number
- NCT00304031
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,173 participants, actual
- Lead sponsor
- Radiation Therapy Oncology Group
- Conditions
- Brain and Central Nervous System Tumors
- Interventions
- Concurrent temozolomide, Concurrent radiation therapy, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle
- First posted
- 2006-03-17
- Last updated
- 2020-06-09
- Results first posted
- 2014-04-30
- Limitations and caveats
- Only participants registered after 07-12-2007 were able to participate in the quality of life / patient reported outcome study components.
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Median Overall Survival Time | From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years. | 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 occurred after 647 deaths were reported. |
| Secondary | Median Progression-free Survival (PFS) Time | From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years. | Progression is defined as greater than 25% increase in tumor area (two diameters) provided that the patient has not had his/her dose of steroids decreased since the last evaluation period. Progression-free survival time is defined as time from registration to the date of first progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method. A concomitant decrease in steroid dose will rule out a progression designation during the first 2 months after completion of radiation therapy. Analysis occurred after 647 deaths were reported. |
| Secondary | Median Overall Survival Time by MGMT Status | From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years. | Overall survival time is defined as time from 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. Tumor tissue submitted at baseline was analyzed to determine MGMT (O\[6\]-methylguanine-DNA methyltransferase) promoter methylation status (methylated / unmethylated). Analysis occurred after 647 deaths were reported. |
| Secondary | Median Progression-free Survival Time by MGMT Status | From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years. | Progression is defined as greater than 25% increase in tumor area (two diameters) provided that the patient has not had his/her dose of steroids decreased since the last evaluation period. Progression-free survival time is defined as time from registration to the date of first progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method. A concomitant decrease in steroid dose will rule out a progression designation during the first 2 months after completion of radiation therapy. Tumor tissue submitted at baseline was analyzed to determine MGMT (O\[6\]-methylguanine-DNA methyltransferase) promoter methylation status (methylated / unmethylated). Analysis occurred after 647 deaths were reported. |
| Secondary | Best Treatment Response by MGMT Status | From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years. | Response assessed using Response Evaluation Criteria in Solid Tumors (RECIST v1.0): Complete Response (CR), imaging no longer shows enhancing tumor, confirmed by a second scan ≥ 4 weeks later; Partial Response (PR), \>=50% decrease in tumor area (two diameters) with patient off all steroids, or on adrenal maintenance only; Minor Response (MR), \< 50% decrease in tumor area with patient off all steroids, or on adrenal maintenance only; Stable Disease (SD): scan shows no change with patient receiving stable/decreasing doses of steroids; Progression (P): \> 25% increase in tumor area with no decrease in steroid dose since last evaluation. Tumor tissue submitted at baseline was analyzed to determine MGMT (O\[6\]-methylguanine-DNA methyltransferase) promoter methylation status (methylated / unmethylated). Analysis occurred after 647 deaths were reported. |
| Secondary | Distribution of Highest Grade AE Reported as Possibly/Probably/Definitely Related to Protocol Treatment | From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years. | Highest grade adverse event (AE) per subject was counted. 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. Analysis occurred after 647 deaths were reported. |
| Secondary | Overall Survival Status by Progression Status at 6 Months | From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years. | Overall survival time is defined as time from registration to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. Progression is defined as greater than 25% increase in tumor area (two diameters) provided that the patient has not had his/her dose of steroids decreased since the last evaluation period. |
| Secondary | Mean MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score at Cycle 10 for Participants Without Progression After 6 Months of Adjuvant Therapy | Baseline and cycle 10 (approximately 46 weeks) | The MDASI-BT is a 28-item patient-reported outcome measure assessing symptom severity and resulting interference with daily living in brain cancer patients. All items range from 0 (not present) to 10 (as bad as you can imagine). The symptom severity score is the average of the symptom severity items, given a specified minimum numbers were completed. |
| Secondary | Mean Neurocognitive Function (NCF) Composite Score at Cycle 10 for Participants Without Progression After 6 Months of Adjuvant Therapy | Baseline and cycle 10 (approximately 46 weeks) | The NCF Composite score is the arithmetic mean of the Hopkins Verbal Learning Test - Revised (HVLT-R) (Free Recall, Delayed Recall, Delayed Recognition), Trail Making Test Part A (TMTA), Trail Making Test Part B (TMTB), and Controlled Oral Word Association (COWA) test 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. |
| Secondary | Mean EORTC QLQ-C30 Global Health Status Score at Cycle 10 for Participants Without Progression After 6 Months of Adjuvant Therapy | Baseline and cycle 10 (approximately 46 weeks) | Global Health Status is calculated from two questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire \[EORTC QLQ\]-C30. The question responses range from 1 "very poor" to 7 "excellent" such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best). |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Median Overall Survival Time | From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years. | Randomized eligible patients. | months | MEDIAN |
| SECONDARY | Median Progression-free Survival (PFS) Time | From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years. | Randomized eligible patients | months | MEDIAN |
| SECONDARY | Median Overall Survival Time by MGMT Status | From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years. | MGMT status was not available for all randomized eligible participants. Therefore, data was only available from 376/411 on the conventional arm and 384/420 on the dose-dense arm. | months | MEDIAN |
| SECONDARY | Median Progression-free Survival Time by MGMT Status | From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years. | MGMT status was not available for all randomized eligible participants. Therefore, data was only available from 376/411 on the conventional arm and 384/420 on the dose-dense arm. | months | MEDIAN |
| SECONDARY | Best Treatment Response by MGMT Status | From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years. | Per the protocol, both arms are combined to compare between MGMT status. MGMT status and treatment response was not available for all randomized eligible participants. Therefore, data was only available for 748/831 randomized eligible patients (arms combined). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Distribution of Highest Grade AE Reported as Possibly/Probably/Definitely Related to Protocol Treatment | From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years. | Randomized eligible patients with any adverse events reported as possibly/probably/definitely related to protocol treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival Status by Progression Status at 6 Months | From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years. | Per the protocol, both arms are combined to compare between 6-month progression status. Eligible pre-randomization participants with any follow-up data. | months | MEDIAN |
| SECONDARY | Mean MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score at Cycle 10 for Participants Without Progression After 6 Months of Adjuvant Therapy | Baseline and cycle 10 (approximately 46 weeks) | Cycle 10 questionnaires were not completed by all quality of life (QOL) population participants progression-free at 6 months. Therefore, only 24/96 on the conventional arm and 20/95 on the dose-dense arm had data. | score on a scale | MEAN |
| SECONDARY | Mean Neurocognitive Function (NCF) Composite Score at Cycle 10 for Participants Without Progression After 6 Months of Adjuvant Therapy | Baseline and cycle 10 (approximately 46 weeks) | Cycle 10 questionnaires were not completed by all QOL population participants progression-free at 6 months. Therefore, only 17/96 on the conventional arm and 20/95 on the dose-dense arm had data. | score on a scale | MEAN |
| SECONDARY | Mean EORTC QLQ-C30 Global Health Status Score at Cycle 10 for Participants Without Progression After 6 Months of Adjuvant Therapy | Baseline and cycle 10 (approximately 46 weeks) | Cycle 10 questionnaires were not completed by all QOL population participants progression-free at 6 months. Therefore, only 24/96 on the conventional arm and 22/95 on the dose-dense arm had data. | score on a scale | MEAN |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 outcomesResults by group101
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Median Overall Survival Time | Conventional Adjuvant TMZ | 16.6 | 95% Confidence Interval 14.9 to 18.0 | months | |
| Median Overall Survival Time | Dose-dense Adjuvant TMZ | 14.9 | 95% Confidence Interval 13.7 to 16.5 | months | |
| Median Progression-free Survival (PFS) Time | Conventional Adjuvant TMZ | 5.5 | 95% Confidence Interval 4.7 to 6.1 | months | |
| Median Progression-free Survival (PFS) Time | Dose-dense Adjuvant TMZ | 6.7 | 95% Confidence Interval 6.2 to 7.7 | months | |
| Median Overall Survival Time by MGMT Status | Conventional Adjuvant TMZ | Unmethylated MGMT | 14.6 | 95% Confidence Interval 13.2 to 16.5 | months |
| Median Overall Survival Time by MGMT Status | Dose-dense Adjuvant TMZ | Unmethylated MGMT | 13.3 | 95% Confidence Interval 12.3 to 14.3 | months |
| Median Overall Survival Time by MGMT Status | Conventional Adjuvant TMZ | Methylated MGMT | 21.4 | 95% Confidence Interval 17.6 to 29.0 | months |
| Median Overall Survival Time by MGMT Status | Dose-dense Adjuvant TMZ | Methylated MGMT | 20.2 | 95% Confidence Interval 15.4 to 25.1 | months |
| Median Progression-free Survival Time by MGMT Status | Conventional Adjuvant TMZ | Unmethylated MGMT | 5.1 | 95% Confidence Interval 4.3 to 5.7 | months |
| Median Progression-free Survival Time by MGMT Status | Dose-dense Adjuvant TMZ | Unmethylated MGMT | 6.0 | 95% Confidence Interval 5.5 to 6.5 | months |
1 to 10 of 101Source ClinicalTrials.gov
See all 101 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Concomitant RT+TMZ (Pre-randomization) | STARTED | No Adjuvant TMZ (Not Randomized) | 1,125 | |
| Concomitant RT+TMZ (Pre-randomization) | STARTED | Conventional Adjuvant TMZ | 0 | |
| Concomitant RT+TMZ (Pre-randomization) | STARTED | Dose-dense Adjuvant TMZ | 0 | |
| Concomitant RT+TMZ (Pre-randomization) | Eligible Pre-randomization Population | No Adjuvant TMZ (Not Randomized) | 1,125 | |
| Concomitant RT+TMZ (Pre-randomization) | Eligible Pre-randomization Population | Conventional Adjuvant TMZ | 0 | |
| Concomitant RT+TMZ (Pre-randomization) | Eligible Pre-randomization Population | Dose-dense Adjuvant TMZ | 0 | |
| Concomitant RT+TMZ (Pre-randomization) | Eligible Pre-randomization Follow-up | No Adjuvant TMZ (Not Randomized) | 1,120 | |
| Concomitant RT+TMZ (Pre-randomization) | Eligible Pre-randomization Follow-up | Conventional Adjuvant TMZ | 0 | |
| Concomitant RT+TMZ (Pre-randomization) | Eligible Pre-randomization Follow-up | Dose-dense Adjuvant TMZ | 0 | |
| Concomitant RT+TMZ (Pre-randomization) | COMPLETED | No Adjuvant TMZ (Not Randomized) | 833 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events789
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 | Hemoglobin | Blood and lymphatic system disorders | No Adjuvant TMZ (Not Randomized) | 69 | 285 | |
| other | Hemoglobin | Blood and lymphatic system disorders | Conventional Adjuvant TMZ | 142 | 409 | |
| other | Hemoglobin | Blood and lymphatic system disorders | Dose-dense Adjuvant TMZ | 171 | 420 | |
| other | Hearing impaired | Ear and labyrinth disorders | No Adjuvant TMZ (Not Randomized) | 8 | 285 | |
| other | Hearing impaired | Ear and labyrinth disorders | Conventional Adjuvant TMZ | 27 | 409 | |
| other | Hearing impaired | Ear and labyrinth disorders | Dose-dense Adjuvant TMZ | 20 | 420 | |
| other | Ocular/visual - Other: | Eye disorders | No Adjuvant TMZ (Not Randomized) | 16 | 285 | |
| other | Ocular/visual - Other: | Eye disorders | Conventional Adjuvant TMZ | 37 | 409 | |
| other | Ocular/visual - Other: | Eye disorders | Dose-dense Adjuvant TMZ | 27 | 420 | |
| other | Vision blurred | Eye disorders | No Adjuvant TMZ (Not Randomized) | 19 | 285 |
1 to 10 of 789Source ClinicalTrials.gov
See all 789 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | No Adjuvant TMZ (Not Randomized) | ||
| Total, all-cause mortality | Conventional Adjuvant TMZ | ||
| Total, all-cause mortality | Dose-dense Adjuvant TMZ | ||
| Total, other adverse events | No Adjuvant TMZ (Not Randomized) | 216 | 285 |
| Total, other adverse events | Conventional Adjuvant TMZ | 376 | 409 |
| Total, other adverse events | Dose-dense Adjuvant TMZ | 392 | 420 |
| Total, serious adverse events | No Adjuvant TMZ (Not Randomized) | 105 | 285 |
| Total, serious adverse events | Conventional Adjuvant TMZ | 131 | 409 |
| Total, serious adverse events | Dose-dense Adjuvant TMZ | 142 | 420 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Conventional Adjuvant TMZ vs Dose-dense Adjuvant TMZ: Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Interference Score at Cycle 4 | Trial comparisons |
| Conventional Adjuvant TMZ vs Dose-dense Adjuvant TMZ: Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score at Cycle 4 | Trial comparisons |
Tests4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
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/NCT00304031
GET https://conductscience.org/api/trials/v1/NCT00304031/registered?page=2