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
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 |
Verified date | May 2023 |
Source | St. Jude Children's Research Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | St. Jude Children's Research Hospital | Memphis | Tennessee |
Lead Sponsor | Collaborator |
---|---|
St. Jude Children's Research Hospital |
United States,
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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