Status:
COMPLETED
Radiation Therapy in Treating Young Patients With Gliomas
Lead Sponsor:
Children's Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain Tumor
Central Nervous System Tumor
Eligibility:
All Genders
3-20 years
Phase:
PHASE2
Brief Summary
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 w...
Detailed Description
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 sur...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2018
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00238264
Start Date
November 1 2006
End Date
December 31 2018
Last Update
August 7 2019
Active Locations (145)
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1
UAB Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
2
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016-7710
3
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
4
Southern California Permanente Medical Group
Downey, California, United States, 90027