A Phase II Study of Image-Guided Radiation Therapy for Pediatric CNS Tumors and Quantification of Radiation-Related CNS Effects
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 361
- Locations
- 2
- Primary Endpoint
- Local Tumor Control
Study Overview
Brief 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.
Detailed Description
Radiation therapy is commonly used to treat a variety of brain tumors in children including ependymoma, craniopharyngioma and low- and high-grade glioma. The ability of the therapy to control brain tumors in children is known to depend on the tumor type, extent of resection and other clinical factors. Children who received radiation therapy on this study were evaluated for treatment failure at 12 months. In addition to the primary objective, the study was designed to explore the association between radiation dose and volume and a variety of neurological, endocrine and cognitive deficits up to 5 years after treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 8 Months to 25 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Local Tumor Control
Time Frame: 12 months after the enrollment of the last therapeutic patient
Local tumor control was determined by Magnetic Resonance Imaging (MRI) of the brain and spine performed after radiation therapy. Imaging studies were performed every 3-4 months during the first three years and then every 6 months through five years. Imaging studies demonstrating tumor progression were electronically registered to the imaging data used to plan therapy. Local failure included tumor progression within the volume that received the prescribed dose of irradiation.
Secondary Outcomes
No secondary outcomes reported