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

Brain Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00187226
• Other study ID #: RT1
• Status: Completed
• Phase: Phase 2
• Start date: June 1997
• Est. completion date: February 1, 2022

Study information

• Verified date: May 2023
• Source: St. Jude Children's Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 361
• Est. completion date: February 1, 2022
• Est. primary completion date: March 31, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Months to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumors
• Central Nervous System Neoplasms
• Central Nervous System Tumors
• Neoplasms
• Nervous System Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local Tumor Control	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.	12 months after the enrollment of the last therapeutic patient

External Links

•   St. Jude Children's Research Hospital