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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00187226
First received: September 13, 2005
Last updated: August 17, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Central Nervous System Tumors
Brain Tumors
Procedure: Radiation Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Image-Guided Radiation Therapy for Pediatric CNS Tumors and Quantification of Radiation-Related CNS Effects

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • Local Tumor Control [ Time Frame: 12 months after the enrollment of the last therapeutic patient ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 202
Study Start Date: June 1997
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Stratum 1
Ependymoma, craniopharyngioma, low-grade glioma
Procedure: Radiation Therapy
External Beam Radiation Therapy: 54Gy administered at 1.8Gy per day for low-grade glioma, craniopharyngioma and selected ependymoma.
Stratum 2
High-grade glioma
Procedure: Radiation Therapy
External Beam Radiation Therapy: 59.4Gy administered at 1.8Gy per day for high-grade glioma and selected ependymoma.

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.

  Eligibility

Ages Eligible for Study:   8 Months to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00187226

Locations
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Thomas E. Merchant, D.O., Ph.D. St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided by St. Jude Children's Research Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00187226     History of Changes
Other Study ID Numbers: RT1
Study First Received: September 13, 2005
Results First Received: May 4, 2012
Last Updated: August 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by St. Jude Children's Research Hospital:
Brain neoplasm
Brain cancer
Neoplasm intracranial

Additional relevant MeSH terms:
Brain Neoplasms
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on October 19, 2014