Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00187226
Recruitment Status : Active, not recruiting
First Posted : September 16, 2005
Results First Posted : August 20, 2012
Last Update Posted : June 3, 2021
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 16, 2005
Results First Submitted Date  ICMJE May 4, 2012
Results First Posted Date  ICMJE August 20, 2012
Last Update Posted Date June 3, 2021
Actual Study Start Date  ICMJE June 1997
Actual Primary Completion Date March 31, 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 17, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • To see if Image-Guided Radiation Therapy has fewer effects than standard radiation therapy
  • To study the effects of radiation on brain growth and development on learning, thinking, hearing, and hormone production.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study for Image-Guided Radiation Therapy in Pediatric Brain Tumors and Side Effects
Official Title  ICMJE A Phase II Study of Image-Guided Radiation Therapy for Pediatric CNS Tumors and Quantification of Radiation-Related CNS Effects
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Central Nervous System Tumors
  • Brain Tumors
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Stratum 1
    Ependymoma, craniopharyngioma, low-grade glioma
    Intervention: Procedure: Radiation Therapy
  • Stratum 2
    High-grade glioma
    Intervention: Procedure: Radiation Therapy
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 17, 2012)
202
Original Enrollment  ICMJE
 (submitted: September 13, 2005)
100
Estimated Study Completion Date  ICMJE February 2022
Actual Primary Completion Date March 31, 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Months to 25 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00187226
Other Study ID Numbers  ICMJE RT1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party St. Jude Children's Research Hospital
Study Sponsor  ICMJE St. Jude Children's Research Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thomas E. Merchant, D.O., Ph.D. St. Jude Children's Research Hospital
PRS Account St. Jude Children's Research Hospital
Verification Date May 2021

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