RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This clinical trial is studying giving radiation therapy or combination chemotherapy to see how well it works in treating patients with clinically or radiologically progressive low-grade gliomas.
Who can participate
Age range1 Day ā 18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically confirmed low-grade glioma, of 1 of the following histologic subtypes:
* Pilocytic astrocytoma I° and variants
* Subependymal giant cell astrocytoma I°
* Dysembryoplastic neuroepithelial tumor I°
* Desmoplastic infantile ganglioglioma I°
* Ganglioglioma I° and II°
* Pleomorphic xanthoastrocytoma II°
* Oligodendroglioma II°
* Oligoastrocytoma II°
* Astrocytoma II°
* Fibrillary astrocytoma II°
* Protoplasmatic astrocytoma II°
* Gemistocytic astrocytoma II°
* Children with chiasmatic-hypothalamic tumors may be eligible without histological diagnosis, if neuroradiologic findings meet unequivocal criteria for the presence of a low-grade glioma
* Primary tumor localization: intracranial and/or spinal cord
* No diffuse intrinsic tumors of the pons, even if histologically an astrocytoma I° or II° is diagnosed
* Exception: pontine glioma II° in neurofibromatosis type 1 (NF1) disease allowed
* Children presenting with disseminated low-grade glioma will be eligible for the study
* All eligible patients without NF1 disease receiving chemotherapy as their first nonsurgical therapy are eligible for randomization
* Children are eligible for the trial regardless of the presence of associated genetic disease: NF1 disease will be the prominent one, all children with NF1 disease are entered into the study arm III in case of an indication for nonsurgical therapy
* Patients presenting with rare intracranial neoplasā¦
What they're measuring
1
Progression-free survival
Timeframe: week 24, and at 1, 3, and 5 years
2
Event-free survival
Timeframe: week 24 and at 1, 3, and 5 years
3
Overall survival
Timeframe: week 24 and at 1, 3, and 5 years
Trial details
NCT IDNCT00276640
SponsorSociete Internationale d'Oncologie Pediatrique