Phase 2
Completed N=202
A Study for Image-Guided Radiation Therapy in Pediatric Brain Tumors and Side Effects
Central Nervous System Tumors · brain tumor
Source: ClinicalTrials.gov NCT00187226 ↗
Enrolled (actual)
202
Serious AEs
2.0%
Results posted
Aug 2012
Primary outcomePrimary: Local Tumor Control — 0.966; 0.959; 1.000; 1.000 Proportion of patients
Summary
The purpose of the study was to determine if treating a limited volume of normal tissue surrounding the tumor or tumor bed using conformal radiation therapy would achieve similar rates of disease control compared to standard radiation therapy. The study was also conducted to examine the effect of irradiation on neurological, endocrine and cognitive function.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Local Tumor Control |
0.966; 0.959; 1.000; 1.000; 0.618; 1.000 | — |
Eligibility Criteria
Inclusion Criteria
- Age at time of irradiation is greater than or equal to 8 months and less than or equal to 25 years
- Histologically diagnosed craniopharyngioma, ependymoma, low-grade astrocytoma or high-grade glioma and radiographically diagnosed selected patients with craniopharyngioma and low-grade glioma.
- Adequate performance status, participant has an ECOG (Performance Status Score) of 0-2(0=Normal Activity; 1=Symptoms but Ambulatory; 2=Bedridden <50% of time)
- Histologic type that requires only focal irradiation.
- No prior fractionated external beam irradiation
- Informed consent signed by patient, parent, or guardian.
Data sourced from ClinicalTrials.gov (NCT00187226). 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. Informational only — not medical advice.