Phase 2
N=202
A Study for Image-Guided Radiation Therapy in Pediatric Brain Tumors and Side Effects
Central Nervous System Tumors · Brain Tumors
Bottom Line
View on ClinicalTrials.gov: NCT00187226 ↗Enrolled (actual)
202
Serious AEs
2.0%
Results posted
Aug 2012
Primary outcome: Primary: Local Tumor Control — 0.966; 0.959; 1.000; 1.000 Proportion of patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Radiation Therapy (Procedure)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- St. Jude Children's Research Hospital
- Primary completion
- Mar 2005
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Local Tumor Control |
0.966; 0.959; 1.000; 1.000; 0.618; 1.000 | — |
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.
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.