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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00187226
Other study ID # RT1
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


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
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