Clinical trial · Interventional
Radiation Therapy in Treating Young Patients With Gliomas
A Phase II Study of Conformal Radiotherapy In Patients With Low-Grade Gliomas
NCT00238264CI-TRIAL-00039918completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
| Central Nervous System Tumor | Central Nervous System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (radiotherapy)
- description
- Patients undergo reduced-field conformal radiation therapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- Marginal-failure Rate
- timeFrame
- Up to 5 years
- description
- Patients who do not recur as well as those with either central or distant recurrence would be treatment successes for this endpoint. Monitoring will be based on a Bayesian rule, with binomial likelihood and a Beta on the parameter p, the proportion of failures that are marginal failures.
Secondary outcomes (6)
- measure
- Progression-free Survival Probability
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 20 Years
Show eligibility criteria text
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 therapyReferences
Publications (1)
- RESULTUlin K, Urie MM, Cherlow JM. Results of a multi-institutional benchmark test for cranial CT/MR image registration. Int J Radiat Oncol Biol Phys. 2010 Aug 1;77(5):1584-9. doi: 10.1016/j.ijrobp.2009.10.017. Epub 2010 Apr 8. PMID 20381270