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NCT01478321 · ClinicalTrials.gov registry record · Phase 2
Efficacy of Hypofractionated XRT w/Bev. + Temozolomide for Recurrent Gliomas
A Phase 2 study, sponsored by Northwestern University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 54
- Enrollment target
NCT01478321: Clinical Trial Phase 2 study, sponsored by Northwestern University.
NCT01478321 is a Phase 2 study that was terminated before completion, run by Northwestern University. The registered enrollment target is 54 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01478321, a Phase 2 study, was terminated before completion, sponsored by Northwestern University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 54 participants
- Enrollment target
Study Summary
This phase II trial studies how well giving hypofractionated radiation therapy together with temozolomide and bevacizumab works in treating patients with high-grade glioblastoma multiforme or anaplastic glioma. Specialized radiation therapy, such as hypofractionated 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. 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. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving hypofractionated radiation therapy together with temozolomide and bevacizumab may kill more tumor cells.
Primary Outcome
Data will be analyzed using Kaplan-Meier curves. OS is defined as the time from first re-irradiation treatment until death from any cause.
Interventions
- DRUG Temozolomide
- OTHER questionnaire administration
- BIOLOGICAL bevacizumab
- RADIATION hypofractionated radiation therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2011-12-14 |
| Est. Completion | 2018-09-12 |
| Phase | Phase 2 |
Why NCT01478321 stopped before completion
NCT01478321 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower).
The record links to 0 conditions, and to 4 interventions - of which Temozolomide is the first listed.
NCT01478321 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01478321 about?
NCT01478321 is a clinical study titled "Efficacy of Hypofractionated XRT w/Bev. + Temozolomide for Recurrent Gliomas". This phase II trial studies how well giving hypofractionated radiation therapy together with temozolomide and bevacizumab works in treating patients with high-grade glioblastoma multiforme or anaplastic glioma. Specialized radiation therapy, such as hypofractionated radiation therapy, that delivers ...
What is the current status of trial NCT01478321?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 54 participants. The study started on 2011-12-14. Estimated completion is 2018-09-12.
What interventions are being tested in trial NCT01478321?
The interventions under investigation include: Temozolomide (DRUG), questionnaire administration (OTHER), bevacizumab (BIOLOGICAL), hypofractionated radiation therapy (RADIATION).
Who is sponsoring clinical trial NCT01478321?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01478321's enrollment target sits among peer trials
54 1160th of 2000 higher than 830 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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