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NCT00841555 · ClinicalTrials.gov registry record · Phase 1
Temozolomide and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Anaplastic Astrocytoma
A Phase 1 study, sponsored by Ohio State University Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT00841555: Completed Phase 1 study, sponsored by Ohio State University Comprehensive Cancer Center.
NCT00841555 is a Phase 1 study that has completed, run by Ohio State University Comprehensive Cancer Center. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00841555, a Phase 1 study, has completed, sponsored by Ohio State University Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
RATIONALE: 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving chemotherapy together with radiation therapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of temozolomide when given together with radiation therapy in treating patients with newly diagnosed glioblastoma multiforme or anaplastic astrocytoma.
Primary Outcome
This study is designed as a phase I dose escalation trial using the Standard Method of dose escalation of three patients per dose level to determine the MTD of TMZ (up to 75 mg/m 2 /day) when TMZ is used with HIMRT for patients with glioblastoma multiforme(GBM) or Anaplastic Astrocytoma(AA)of the brain. The 3 dose levels will be evaluated using the standard method to determine if either represents an MTD based on DLT. If DLT is not observed at all doses level, the greater of the three levels wil
Interventions
- RADIATION Hypofractionated radiation therapy
- RADIATION Intensity-modulated radiation therapy
- DRUG temozolomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2009-02-13 |
| Est. Completion | 2014-11-25 |
| Phase | Phase 1 |
What the finished NCT00841555 record still lists
NCT00841555 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 3 interventions - of which Hypofractionated radiation therapy is the first listed.
NCT00841555 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00841555 about?
NCT00841555 is a clinical study titled "Temozolomide and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Anaplastic Astrocytoma". RATIONALE: 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose...
What is the current status of trial NCT00841555?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2009-02-13. Estimated completion is 2014-11-25.
What interventions are being tested in trial NCT00841555?
The interventions under investigation include: Hypofractionated radiation therapy (RADIATION), Intensity-modulated radiation therapy (RADIATION), temozolomide (DRUG).
Who is sponsoring clinical trial NCT00841555?
This trial is sponsored by Ohio State University Comprehensive Cancer Center, which has 341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00841555's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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