Phase 2
N=45
A Study of Capecitabine (Xeloda®) and Concomitant Radiation Therapy in Children With Newly Diagnosed Brainstem Gliomas
Brainstem Glioma
Bottom Line
View on ClinicalTrials.gov: NCT01118377 ↗Enrolled (actual)
45
Serious AEs
52.3%
Results posted
Dec 2013
Primary outcome: Primary: Progression-free Survival — 4.9 Months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Capecitabine (Drug); Radiation therapy (Radiation)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival |
4.9 | — |
| SECONDARY Overall Survival |
10.3 | — |
| SECONDARY Percentage of Participants With a Tumor Response |
2.3 | — |
Summary
This study evaluated the effect of capecitabine and concomitant radiation therapy in children with newly diagnosed brainstem gliomas.
Eligibility Criteria
Inclusion Criteria
- Pediatric and adolescent patients ≥ 3 to 16 years of age) or Lansky Performance Score (if ≤ 16 years of age) ≥ 50% assessed within 2 weeks prior to registration to study.
- Patients must not have received any prior chemotherapy or bone marrow transplant for the treatment of brainstem glioma. Prior dexamethasone and/or surgery are allowed.
- Adequate organ function.
Exclusion Criteria
- Patients receiving any other anticancer or experimental drug therapy.
- Patients with uncontrolled infection.
- Known dihydropyrimidine dehydrogenase (DPD) deficiency.
Data sourced from ClinicalTrials.gov (NCT01118377). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.