NCT00187226

A Study for Image-Guided Radiation Therapy in Pediatric Brain Tumors and Side Effects

A Phase II Study of Image-Guided Radiation Therapy for Pediatric CNS Tumors and Quantification of Radiation-Related CNS Effects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 361 (actual)
• Sponsor: St. Jude Children's Research Hospital · Academic / Other
• Sex: All
• Age: 8 Months – 25 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Central Nervous System Tumors
• Brain Tumors

Interventions

Type	Name	Description
PROCEDURE	Radiation Therapy	External Beam Radiation Therapy: 54Gy administered at 1.8Gy per day for low-grade glioma, craniopharyngioma and selected ependymoma.
PROCEDURE	Radiation Therapy	External Beam Radiation Therapy: 59.4Gy administered at 1.8Gy per day for high-grade glioma and selected ependymoma.

Timeline

• Start date: 1997-06-01
• Primary completion: 2005-03-31
• Completion: 2022-02-01
• First posted: 2005-09-16
• Last updated: 2023-05-31
• Results posted: 2012-08-20

Locations

1 site across 1 country: United States