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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

361 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-06-30

Study Completion Date

2022-02-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Central Nervous System Tumors Brain Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stratum 1

Ependymoma, craniopharyngioma, low-grade glioma

Group Type OTHER

Radiation Therapy

Intervention Type PROCEDURE

External Beam Radiation Therapy: 54Gy administered at 1.8Gy per day for low-grade glioma, craniopharyngioma and selected ependymoma.

Stratum 2

High-grade glioma

Group Type OTHER

Radiation Therapy

Intervention Type PROCEDURE

External Beam Radiation Therapy: 59.4Gy administered at 1.8Gy per day for high-grade glioma and selected ependymoma.

Interventions

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Radiation Therapy

External Beam Radiation Therapy: 54Gy administered at 1.8Gy per day for low-grade glioma, craniopharyngioma and selected ependymoma.

Intervention Type PROCEDURE

Radiation Therapy

External Beam Radiation Therapy: 59.4Gy administered at 1.8Gy per day for high-grade glioma and selected ependymoma.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

8 Months

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No