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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

September 13, 2005
August 17, 2012
June 1997
March 2005   (final data collection date for primary outcome measure)
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.
  • To study the effects of radiation on brain growth and development on learning, thinking, hearing, and hormone production.
  • To see if Image-Guided Radiation Therapy has fewer effects than standard radiation therapy
Complete list of historical versions of study NCT00187226 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Study for Image-Guided Radiation Therapy in Pediatric Brain Tumors and Side Effects
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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Central Nervous System Tumors
  • Brain Tumors
  • Procedure: Radiation Therapy
    External Beam Radiation Therapy: 54Gy administered at 1.8Gy per day for low-grade glioma, craniopharyngioma and selected ependymoma.
  • Procedure: Radiation Therapy
    External Beam Radiation Therapy: 59.4Gy administered at 1.8Gy per day for high-grade glioma and selected ependymoma.
  • Stratum 1
    Ependymoma, craniopharyngioma, low-grade glioma
    Intervention: Procedure: Radiation Therapy
  • Stratum 2
    High-grade glioma
    Intervention: Procedure: Radiation Therapy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
202
March 2005
March 2005   (final data collection date for primary outcome measure)

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.
Both
8 Months to 25 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00187226
RT1
No
St. Jude Children's Research Hospital
St. Jude Children's Research Hospital
Not Provided
Principal Investigator: Thomas E. Merchant, D.O., Ph.D. St. Jude Children's Research Hospital
St. Jude Children's Research Hospital
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP