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

Phase 2

Completed

• Conditions: Brain Tumors; Central Nervous System Tumors
• Interventions: Procedure: Radiation Therapy

• Registration Number: NCT00187226
• Lead Sponsor: St. Jude Children's Research Hospital

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 Timeline

• Study Start: 1997-06
• Primary Completion: 2005-03-31
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Results First Submitted: 2012-05-04
• Results First Submitted QC: 2012-08-17
• Results First Posted: 2012-08-20
• Study Completion: 2022-02-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-25
• Last Update Posted: 2023-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 361

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stratum 1	Radiation Therapy	Ependymoma, craniopharyngioma, low-grade glioma
Stratum 2	Radiation Therapy	High-grade glioma

Primary Outcome Measures

Name	Time	Method
Local Tumor Control	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.

Trial Locations

Locations (1)

St. Jude Children's Research Hospital; 🇺🇸 Memphis, Tennessee, United States