Trial · NCT00482677
Radiation Therapy With or Without Temozolomide in Treating Older Patients With Newly Diagnosed Glioblastoma Multiforme
NCT00482677, Phase 3, Completed, Canadian Cancer Trials Group; results first posted 2018-01-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Radiation Therapy With or Without Temozolomide in Treating Older Patients With Newly Diagnosed Glioblastoma Multiforme. Trials, record NCT00482677. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00482677
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Radiation Therapy With or Without Temozolomide in Treating Older Patients With Newly Diagnosed Glioblastoma Multiforme
- NCT number
- NCT00482677
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 562 participants, actual
- Lead sponsor
- Canadian Cancer Trials Group
- Conditions
- Brain and Central Nervous System Tumors
- Interventions
- temozolomide, DNA methylation analysis, quality-of-life assessment, Radiation
- First posted
- 2007-06-05
- Last updated
- 2023-08-22
- Results first posted
- 2018-01-23
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | 7 years | Time from date of randomization to the date of death of any causes, or censored at last known alive date. |
| Secondary | Progression-free Survival | 7 years | Time from date of randomization to the date of disease progression or death whichever came first, or censored at last disease assessment date. |
| Secondary | Adverse Events | 7 years | Evaluated according to CTCAE V3.0 |
| Secondary | Methylation Status of the O6-methylguanine-DNA Methyltransferase Promoter | 7 years | Overall survival for patients by Methylation status of the O6-methylguanine-DNA methyltransferase promoter |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | 7 years | Months | MEDIAN | |
| SECONDARY | Progression-free Survival | 7 years | Months | MEDIAN | |
| SECONDARY | Adverse Events | 7 years | |||
| SECONDARY | Methylation Status of the O6-methylguanine-DNA Methyltransferase Promoter | 7 years | Patients with MGMT promoter methylated. | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Temozolomide | 9.33 | 95% Confidence Interval 8.31 to 10.25 | Months | |
| Overall Survival | Radiation | 7.62 | 95% Confidence Interval 6.97 to 8.38 | Months | |
| Progression-free Survival | Temozolomide | 5.29 | 95% Confidence Interval 4.60 to 6.21 | Months | |
| Progression-free Survival | Radiation | 3.94 | 95% Confidence Interval 3.52 to 4.34 | Months | |
| Methylation Status of the O6-methylguanine-DNA Methyltransferase Promoter | Temozolomide | 13.47 | 95% Confidence Interval 10.25 to 15.31 | Months | |
| Methylation Status of the O6-methylguanine-DNA Methyltransferase Promoter | Radiation | 7.69 | 95% Confidence Interval 5.82 to 10.68 | Months |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Temozolomide | 281 | |
| Overall Study | STARTED | Radiation | 281 | |
| Overall Study | COMPLETED | Temozolomide | 281 | |
| Overall Study | COMPLETED | Radiation | 281 | |
| Overall Study | NOT COMPLETED | Temozolomide | 0 | |
| Overall Study | NOT COMPLETED | Radiation | 0 |
Source ClinicalTrials.gov
Adverse events362
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 | Hearing (without monitoring program) | Ear and labyrinth disorders | Temozolomide | 15 | 271 | |
| other | Hearing (without monitoring program) | Ear and labyrinth disorders | Radiation | 14 | 271 | |
| other | Blurred vision | Eye disorders | Temozolomide | 15 | 271 | |
| other | Blurred vision | Eye disorders | Radiation | 21 | 271 | |
| other | Constipation | Gastrointestinal disorders | Temozolomide | 74 | 271 | |
| other | Constipation | Gastrointestinal disorders | Radiation | 29 | 271 | |
| other | Diarrhea | Gastrointestinal disorders | Temozolomide | 19 | 271 | |
| other | Diarrhea | Gastrointestinal disorders | Radiation | 5 | 271 | |
| other | Dysphagia | Gastrointestinal disorders | Temozolomide | 20 | 271 | |
| other | Dysphagia | Gastrointestinal disorders | Radiation | 18 | 271 |
1 to 10 of 362Source ClinicalTrials.gov
See all 362 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Temozolomide | ||
| Total, all-cause mortality | Radiation | ||
| Total, other adverse events | Temozolomide | 260 | 271 |
| Total, other adverse events | Radiation | 256 | 271 |
| Total, serious adverse events | Temozolomide | 158 | 271 |
| Total, serious adverse events | Radiation | 135 | 271 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Temozolomide vs Radiation: serious adverse events |
Source Trial comparisons
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/NCT00482677
GET https://conductscience.org/api/trials/v1/NCT00482677/events?page=2