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NCT00532948 · ClinicalTrials.gov registry record · Phase 1
A Study of Xeloda (Capecitabine) Plus Radiation Therapy in Children With Newly Diagnosed Gliomas
A Phase 1 study of Glioma, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 9
- Study locations
NCT00532948: Completed Phase 1 study of Glioma, sponsored by Hoffmann-La Roche.
NCT00532948 is a Phase 1 study of Glioma that has completed, run by Hoffmann-La Roche. The registered enrollment target is 24 participants, below the 210-participant average among 87 other Glioma trials with a reported enrollment target (89% lower). The trial reports 9 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00532948, a Phase 1 study of Glioma, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 9
- Study locations
Study Summary
This single arm study will assess the maximum tolerated dose, and dose-limiting toxicities, of Xeloda administered concurrently with radiation therapy, in children with newly diagnosed diffuse intrinsic brain stem gliomas and high grade gliomas. Xeloda will be administered twice daily, at a starting dose of 500mg/m2 bid, beginning within 24 hours of the start of radiation therapy. Subsequent dose escalations will be in increments of 30%, using a standard dose escalation schema. Post-radiation therapy with Xeloda will continue after a 2 week break. The anticipated time on study treatment is 3-12 months, and the target sample size will not exceed 30 evaluable patients.
Primary Outcome
The MTD was the dose level at which six evaluable patients had been treated and at most one patient experienced a dose limiting toxicity (DLT) and the next highest dose level was too toxic. Dose escalation occurred if 0 out of 3 or at most 1 out of 6 patients experienced DLT while being treated at a dose level; otherwise the dose was declared unsafe and thus above the MTD.
Conditions Studied
Interventions
- DRUG capecitabine [Xeloda]
Study Locations (9)
Pennsylvania
- - Philadelphia
- - Pittsburgh
California
- - San Francisco
District of Columbia
- - Washington D.C.
Illinois
- - Chicago
Massachusetts
- - Boston
North Carolina
- - Durham
Texas
- - Houston
Washington
- - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2007-05 |
| Est. Completion | 2010-10 |
| Phase | Phase 1 |
What the finished NCT00532948 record still lists
NCT00532948 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 210-participant average among 87 other Glioma trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Glioma appearing as the primary indexed condition, and to 1 intervention - of which capecitabine [Xeloda] is the first listed.
NCT00532948 lists 9 locations in 8 states (Pennsylvania, California, District of Columbia).
Frequently Asked Questions
What is clinical trial NCT00532948 about?
NCT00532948 is a clinical study titled "A Study of Xeloda (Capecitabine) Plus Radiation Therapy in Children With Newly Diagnosed Gliomas". This single arm study will assess the maximum tolerated dose, and dose-limiting toxicities, of Xeloda administered concurrently with radiation therapy, in children with newly diagnosed diffuse intrinsic brain stem gliomas and high grade gliomas. Xeloda will be administered twice daily, at a starting...
What is the current status of trial NCT00532948?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2007-05. Estimated completion is 2010-10.
What conditions does trial NCT00532948 study?
This clinical trial studies the following conditions: Glioma.
What interventions are being tested in trial NCT00532948?
The interventions under investigation include: capecitabine [Xeloda] (DRUG).
Who is sponsoring clinical trial NCT00532948?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00532948 being conducted?
This trial has 9 study locations across California, District of Columbia, Illinois, Massachusetts, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Glioma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00532948's enrollment target sits among peer trials
24 64th of 87 higher than 24 of 87 other Glioma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioma 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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