Back to resultsA Study for Image-Guided Radiation Therapy in Pediatric Brain Tumors and Side Effects
Primary Purpose
Central Nervous System Tumors, Brain Tumors
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Radiation Therapy
Radiation Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Central Nervous System Tumors focused on measuring Brain neoplasm, Brain cancer, Neoplasm intracranial
Eligibility Criteria
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.
Sites / Locations
- St. Jude Children's Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Stratum 1
Stratum 2
Arm Description
Ependymoma, craniopharyngioma, low-grade glioma
High-grade glioma
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00187226
First Posted
September 13, 2005
Last Updated
May 25, 2023
Sponsor
St. Jude Children's Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00187226
Brief Title
A Study for Image-Guided Radiation Therapy in Pediatric Brain Tumors and Side Effects
Official Title
A Phase II Study of Image-Guided Radiation Therapy for Pediatric CNS Tumors and Quantification of Radiation-Related CNS Effects
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 1997 (Actual)
Primary Completion Date
March 31, 2005 (Actual)
Study Completion Date
February 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Jude Children's Research Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Nervous System Tumors, Brain Tumors
Keywords
Brain neoplasm, Brain cancer, Neoplasm intracranial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
361 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stratum 1
Arm Type
Other
Arm Description
Ependymoma, craniopharyngioma, low-grade glioma
Arm Title
Stratum 2
Arm Type
Other
Arm Description
High-grade glioma
Intervention Type
Procedure
Intervention Name(s)
Radiation Therapy
Intervention Description
External Beam Radiation Therapy: 54Gy administered at 1.8Gy per day for low-grade glioma, craniopharyngioma and selected ependymoma.
Intervention Type
Procedure
Intervention Name(s)
Radiation Therapy
Intervention Description
External Beam Radiation Therapy: 59.4Gy administered at 1.8Gy per day for high-grade glioma and selected ependymoma.
Primary Outcome Measure Information:
Title
Local Tumor Control
Description
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.
Time Frame
12 months after the enrollment of the last therapeutic patient
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Months
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas E. Merchant, D.O., Ph.D.
Organizational Affiliation
St. Jude Children's Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23245284
Citation
Netson KL, Conklin HM, Wu S, Xiong X, Merchant TE. Longitudinal investigation of adaptive functioning following conformal irradiation for pediatric craniopharyngioma and low-grade glioma. Int J Radiat Oncol Biol Phys. 2013 Apr 1;85(5):1301-6. doi: 10.1016/j.ijrobp.2012.10.031. Epub 2012 Dec 11.
Results Reference
derived
Links:
URL
http://www.stjude.org
Description
St. Jude Children's Research Hospital
Learn more about this trial
A Study for Image-Guided Radiation Therapy in Pediatric Brain Tumors and Side Effects
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