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NCT01118377 · ClinicalTrials.gov registry record · Phase 2
A Study of Capecitabine (Xeloda®) and Concomitant Radiation Therapy in Children With Newly Diagnosed Brainstem Gliomas
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
NCT01118377: Completed Phase 2 study, sponsored by Hoffmann-La Roche.
NCT01118377 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 45 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01118377, a Phase 2 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
Study Summary
This study evaluated the effect of capecitabine and concomitant radiation therapy in children with newly diagnosed brainstem gliomas.
Primary Outcome
Progression-free survival was defined as the time from the initiation of treatment to the earliest date of failure (disease progression, death from any cause, or a second malignancy) or to the last assessment date for patients who did not fail. Disease progression was defined as progressive neurologic abnormalities or worsening neurologic status not explained by causes unrelated to tumor progression (eg, anticonvulsant or corticosteroid toxicity, electrolyte disturbances, sepsis, hyperglycemia,
Interventions
- DRUG Capecitabine
- RADIATION Radiation therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2007-05 |
| Est. Completion | 2013-04 |
| Phase | Phase 2 |
What the finished NCT01118377 record still lists
NCT01118377 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower).
The record links to 0 conditions, and to 2 interventions - of which Capecitabine is the first listed.
NCT01118377 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01118377 about?
NCT01118377 is a clinical study titled "A Study of Capecitabine (Xeloda®) and Concomitant Radiation Therapy in Children With Newly Diagnosed Brainstem Gliomas". This study evaluated the effect of capecitabine and concomitant radiation therapy in children with newly diagnosed brainstem gliomas.
What is the current status of trial NCT01118377?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2007-05. Estimated completion is 2013-04.
What interventions are being tested in trial NCT01118377?
The interventions under investigation include: Capecitabine (DRUG), Radiation therapy (RADIATION).
Who is sponsoring clinical trial NCT01118377?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01118377's enrollment target sits among peer trials
45 1296th of 2000 higher than 679 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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