Combination Chemotherapy and Radiation Therapy in Treating Patients With Germ Cell Tumors in the … (NCT00293358) | Clinical Trial Compass
CompletedPhase 3
Combination Chemotherapy and Radiation Therapy in Treating Patients With Germ Cell Tumors in the Brain
Ireland, United Kingdom500 participantsStarted 1997-01
Plain-language summary
RATIONALE: Drugs used in chemotherapy, such as carboplatin, etoposide, ifosfamide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) with radiation therapy may kill more tumor cells.
PURPOSE: This phase III trial is studying combination chemotherapy followed by radiation therapy to see how well it works compared to radiation therapy alone in treating patients with germ cell tumors in the brain.
Who can participate
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:
* Clinical and radiological evidence of intracranial germ cell tumor, classified as 1 of the following:
* Germinoma
* Pure germinoma
* Germinoma with mature and/or immature teratoma
* Secreting germ cell tumor
* Elevated tumor markers in serum and/or cerebral spinal fluid as evidenced by any of the following:
* Alpha-fetoprotein \> 25 ng/mL
* β-human choriogonadotropin \> 50 IU/L
* Any tumor containing 1 of these components:
* Yolk sac tumor
* Choriocarcinoma
* Embryonal tumor
* Normal tumor markers allowed
* Diagnosis confirmed by histology or elevated serum markers
* Metastatic or nonmetastatic disease
* Two separate tumors in the suprasellar and pineal areas without evidence of metastatic disease elsewhere are considered nonmetastatic multifocal disease
* Study treatment must begin ≤ 4 weeks after diagnosis
* No pure immature or mature teratomas
* The following additional patients are eligible:
* Patients who are \> 18 years of age provided no other appropriate protocol exists
* Patients who were diagnosed \> 4 weeks ago
* Patients who are in relapse
PATIENT CHARACTERISTICS:
* Not specified
PRIOR CONCURRENT THERAPY:
* No prior treatment except surgery
* No concurrent amino glycosides or other nephrotoxic drugs during ifosfamide administration
* No concurrent growth factors
* No other concurrent chemotherapy or radiotherapy
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.