Clinical Trials

Radiation Therapy in Treating Young Patients With Gliomas

Location:

Trial status:

Inactive

Why is this study being done?

OBJECTIVES:

Primary

- Determine the marginal-failure rate in young patients with low-grade gliomas treated with reduced-field conformal radiotherapy.

Secondary

- Determine the progression-free survival, event-free survival, and overall survival rates of young patients treated with this regimen.

- Determine quality of life of patients treated with this regimen.

- Correlate MIB-1 labeling index with progression-free survival and overall survival of these patients.

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.

Who is eligible to participate?

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:

- Fibrillary astrocytoma

- Gemistocytic astrocytoma

- Subependymal giant cell astrocytoma

- Pleomorphic xanthoastrocytoma

- 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

- Any location in the brain

- 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)

- Prior chemotherapy optional (for patients ≥ 10 years of age)

- No type-1 neurofibromatosis

- No evidence of leptomeningeal dissemination

PATIENT CHARACTERISTICS:

Age

- 3 to 20

Performance status

- ECOG 0-2 OR

- Karnofsky 50-100% (for patients > 16 years of age) OR

- Lansky 50-100% (for patients ≤ 16 years of age)

Life expectancy

- At least 1 year

Hematopoietic

- Absolute neutrophil count ≥ 1,000/mm^3

- Platelet count ≥ 100,000/mm^3 (transfusion independent)

- Hemoglobin ≥ 10.0 g/dL (transfusions allowed)

Hepatic

- Not specified

Renal

- Not specified

Other

- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception

- Not in status epilepticus, coma, or requiring assisted ventilation prior to study entry

- Patients with a seizure disorder are eligible provided they are on anticonvulsants AND disease is well controlled

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- See Disease Characteristics

- Recovered from prior chemotherapy

- No concurrent chemotherapy

Endocrine therapy

- Concurrent dexamethasone allowed provided patient has been on a stable dose for ≥ 2 weeks prior to study entry

- Concurrent dexamethasone allowed for symptoms of increased intracranial pressure

Radiotherapy

- No prior radiotherapy

Surgery

- See Disease Characteristics

Other

- No other concurrent anticancer therapy

Last updated: 08/03/2012

NCT ID:

NCT00238264