Phase 2
N=92
Radiation Therapy in Treating Young Patients With Gliomas
Brain Tumor · Central Nervous System Tumor
Bottom Line
View on ClinicalTrials.gov: NCT00238264 ↗Enrolled (actual)
92
Serious AEs
5.9%
Results posted
Feb 2017
Primary outcome: Primary: Marginal-failure Rate — 0 percentage of failure rate
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- radiation therapy (Radiation)
- Age
- Pediatric, Adult · 3+ yrs
- Sex
- All
- Sponsor
- Children's Oncology Group
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Marginal-failure Rate |
— | — |
| SECONDARY Progression-free Survival Probability |
77.1 | — |
| SECONDARY Event-free Survival Probability |
77.1 | — |
| SECONDARY Overall Survival Probability |
94.0 | — |
| SECONDARY Quality of Life (QOL) |
— | — |
| SECONDARY MIB-1 Labeling Index Using Immunohistochemical Techniques With the MIB-1 Antibody According to Established Methods |
3.1 | — |
| SECONDARY Correlation MIB-1 Labeling Index With PFS |
1.08 | — |
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 well radiation therapy works in treating young patients with gliomas.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT00238264). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.