Combination Chemotherapy and Radiation Therapy With or Without Methotrexate in Treating Young Pat… (NCT00278278) | Clinical Trial Compass
UnknownPhase 3
Combination Chemotherapy and Radiation Therapy With or Without Methotrexate in Treating Young Patients With Newly Diagnosed Gliomas
United States150 participantsStarted 2003-09
Plain-language summary
RATIONALE: 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. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether giving methotrexate together with combination chemotherapy and radiation therapy is more effective than combination chemotherapy and radiation therapy alone in treating gliomas.
PURPOSE: This randomized phase III trial is studying giving methotrexate together with combination chemotherapy and radiation therapy to see how well it works compared to combination chemotherapy and radiation therapy alone in treating young patients with newly diagnosed gliomas.
Who can participate
Age range
3 Years – 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:
* Newly diagnosed tumors of the brain or spinal cord, meeting one of the following criteria:
* Histologically\* confirmed diagnosis of 1 of the following high-grade gliomas:
* Glioblastoma (WHOº IV)
* Anaplastic astrocytoma (WHOº III)
* Gliosarcoma (WHOº III or IV)
* Anaplastic oligo-astrocytoma NOTE: \*Histological requirement may be waived for other types of brainstem glioma
* Radiologically proven diffuse intrinsic pontine glioma
* Second malignancy or disseminate metastases or multifocal tumors are allowed if the field of irradiation is not too large
* No diffuse metastases making craniospinal irradiation necessary
PATIENT CHARACTERISTICS:
* No cardiorespiratory insufficiency requiring medical respiration
* No low blood pressure requiring systemic catecholamines
* No severe neurological damage (e.g., coma)
* No tetraplegia without possibility to communicate
* No other poor clinical condition
* Not pregnant
* Fertile patients must use effective contraception
* No hypersensitivity to methotrexate, cisplatin, vincristine, lomustine, or ifosfamide
* No other malignancy preceding radiotherapy that does not allow further radiation
PRIOR CONCURRENT THERAPY:
* No prior chemotherapy for brain tumor
* The following prior therapies are allowed:
* Mistletoe
* H15 (extract of Boswellia serrata)
* Homeopathy therapy with dilution \> 4D
* Alternative medicine without proven efficacy
* No prior radiotherapy for brain tumor
*…
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
1
Overall survival (OS) rate at 5.5 years
Trial details
NCT IDNCT00278278
SponsorGerman Society for Pediatric Oncology and Hematology GPOH gGmbH