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A Phase II Study of Image-Guided Radiation Therapy for Pediatric CNS Tumors and Quantification of Radiation-Related CNS Effects


Phase 2
8 Months
25 Years
Not Enrolling
Both
Central Nervous System Tumors, Brain Tumors

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Trial Information

A Phase II Study of Image-Guided Radiation Therapy for Pediatric CNS Tumors and Quantification of Radiation-Related CNS Effects


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Local Tumor Control

Outcome 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.

Outcome Time Frame:

12 months after the enrollment of the last therapeutic patient

Safety Issue:

Yes

Principal Investigator

Thomas E. Merchant, D.O., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Institutional Review Board

Study ID:

RT1

NCT ID:

NCT00187226

Start Date:

June 1997

Completion Date:

March 2005

Related Keywords:

  • Central Nervous System Tumors
  • Brain Tumors
  • Brain neoplasm
  • Brain cancer
  • Neoplasm intracranial
  • Brain Neoplasms
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794