- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00187226
A Study for Image-Guided Radiation Therapy in Pediatric Brain Tumors and Side Effects
May 25, 2023 updated by: St. Jude Children's Research Hospital
A Phase II Study of Image-Guided Radiation Therapy for Pediatric CNS Tumors and Quantification of Radiation-Related CNS Effects
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
361
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tennessee
-
Memphis, Tennessee, United States, 38105
- St. Jude Children's Research Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 months to 25 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Stratum 1
Ependymoma, craniopharyngioma, low-grade glioma
|
External Beam Radiation Therapy: 54Gy administered at 1.8Gy per day for low-grade glioma, craniopharyngioma and selected ependymoma.
External Beam Radiation Therapy: 59.4Gy administered at 1.8Gy per day for high-grade glioma and selected ependymoma.
|
Other: Stratum 2
High-grade glioma
|
External Beam Radiation Therapy: 54Gy administered at 1.8Gy per day for low-grade glioma, craniopharyngioma and selected ependymoma.
External Beam Radiation Therapy: 59.4Gy administered at 1.8Gy per day for high-grade glioma and selected ependymoma.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Local Tumor Control
Time Frame: 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.
|
12 months after the enrollment of the last therapeutic patient
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Thomas E. Merchant, D.O., Ph.D., St. Jude Children's Research Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 1997
Primary Completion (Actual)
March 31, 2005
Study Completion (Actual)
February 1, 2022
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimated)
September 16, 2005
Study Record Updates
Last Update Posted (Actual)
May 31, 2023
Last Update Submitted That Met QC Criteria
May 25, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RT1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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