A Phase II Study of Conformal Radiotherapy In Patients With Low-Grade Gliomas
A Phase II Study of Conformal Radiotherapy In Patients With Low-Grade Gliomas
RATIONALE: Specialized radiation therapy that delivers radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: This phase II trial is studying how well radiation therapy works in treating young patients with gliomas.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients undergo reduced-field conformal radiotherapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline or 6 weeks after completion of study treatment and then at 2 and 5 years (closed as of 10/27/2010).
After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
DISEASE CHARACTERISTICS:
Histologically confirmed* low-grade glioma, including any of the following:
Juvenile pilocytic astrocytoma (JPA) or pleomorphic JPA
Diffuse astrocytoma, including any of the following subtypes:
Low-grade oligoastrocytoma
Low-grade oligodendroglioma
Low-grade glioma not otherwise specified NOTE: *Patients with chiasmatic lesions who have contiguous extension of tumor into other regions of the visual pathway by CT scan or MRI are eligible without histopathologic confirmation; repeat biopsy required for patients with recurrent tumors that enhance but whose initial tumor did not
Measurable disease by radiography
Meets any of the following criteria:
Progressive nonresectable disease
Patients with a less than gross total resection are eligible provided they are symptomatic from their tumor OR the risk from neurologic impairment with progression is high enough to warrant immediate treatment
Has undergone biopsy only
Must have received ≥ 1 course of prior chemotherapy (for patients < 10 years of age)
No type-1 neurofibromatosis
No evidence of leptomeningeal dissemination
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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