CompletedNot Applicable

Radiation Therapy or Combination Chemotherapy in Treating Patients With Clinically or Radiologically Progressive Low-Grade Gliomas

Austria, Belgium, Croatia3,417 participantsStarted 2004-04-01

Plain-language summary

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 range

1 Day – 18 Years

Sex

ALL

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 neoplas…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Progression-free survival

Timeframe: week 24, and at 1, 3, and 5 years

Event-free survival

Timeframe: week 24 and at 1, 3, and 5 years

Overall survival

Timeframe: week 24 and at 1, 3, and 5 years

Trial details

NCT IDNCT00276640

SponsorSociete Internationale d'Oncologie Pediatrique

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-12-31

View on ClinicalTrials.gov More Primary Central Nervous System Neoplasms trials