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NCT00304031 · ClinicalTrials.gov registry record · Phase 3
Radiation Therapy (RT) and Temozolomide (TMZ) in Treating Patients With Newly Diagnosed Glioblastoma or Gliosarcoma
A Phase 3 study, sponsored by Radiation Therapy Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,173
- Enrollment target
NCT00304031: Completed Phase 3 study, sponsored by Radiation Therapy Oncology Group.
NCT00304031 is a Phase 3 study that has completed, run by Radiation Therapy Oncology Group. The registered enrollment target is 1,173 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00304031, a Phase 3 study, has completed, sponsored by Radiation Therapy Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,173 participants
- Enrollment target
Study Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. 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. Giving radiation therapy together with temozolomide may kill more tumor cells. It is not yet known which schedule of temozolomide when given together with radiation therapy is more effective in treating glioblastoma or gliosarcoma. PURPOSE: This randomized phase III trial is studying two different schedules of temozolomide to compare how well they work when given together with radiation therapy in treating patients with newly diagnosed glioblastoma or gliosarcoma.
Primary Outcome
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.
Interventions
- DRUG Concurrent temozolomide
- RADIATION Concurrent radiation therapy
- DRUG 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle
- DRUG 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,173 participants |
| Start Date | 2006-01 |
| Est. Completion | 2016-12 |
| Phase | Phase 3 |
What the finished NCT00304031 record still lists
NCT00304031 is an interventional study that assigns participants to a tested intervention. Its 1,173 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% higher).
The record links to 0 conditions, and to 4 interventions - of which Concurrent temozolomide is the first listed.
NCT00304031 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00304031 about?
NCT00304031 is a clinical study titled "Radiation Therapy (RT) and Temozolomide (TMZ) in Treating Patients With Newly Diagnosed Glioblastoma or Gliosarcoma". RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. 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. Giving radiation therapy together with temozolomide may...
What is the current status of trial NCT00304031?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,173 participants. The study started on 2006-01. Estimated completion is 2016-12.
What interventions are being tested in trial NCT00304031?
The interventions under investigation include: Concurrent temozolomide (DRUG), Concurrent radiation therapy (RADIATION), 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle (DRUG), 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle (DRUG).
Who is sponsoring clinical trial NCT00304031?
This trial is sponsored by Radiation Therapy Oncology Group, which has 144 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00304031's enrollment target sits among peer trials
1,173 235th of 2000 higher than 1,766 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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