Surgery and Combination Chemotherapy in Treating Children With Extracranial Germ Cell Tumors (NCT00053352) | Clinical Trial Compass
CompletedPhase 3
Surgery and Combination Chemotherapy in Treating Children With Extracranial Germ Cell Tumors
United States, Australia, Canada302 participantsStarted 2003-11-03
Plain-language summary
This phase III trial is studying surgery followed by combination chemotherapy to see how well it works in treating children with germ cell tumors that are not located in the head. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, and giving them after surgery, may kill any remaining tumor cells following surgery. It is not yet known whether combination chemotherapy is effective in decreasing the recurrence of childhood germ cell tumors.
Who can participate
Age range
21 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.
Inclusion Criteria:
* Extracranial germ cell tumor that contains 1 of the following malignant histologies: NOTE: Mixed germ cell tumors that include mature/immature teratoma are eligible provided 1 of the 3 histologies listed above is also present in the tumor.
* Yolk sac tumor
* Embryonal carcinoma
* Choriocarcinoma
* Low-risk disease (closed to accrual as of 01/20/10)
* Stage I gonadal tumors (ovarian and testicular)
* Must have undergone complete surgical and radiologic staging to exclude the possibility of \> stage I disease
* Intermediate-risk disease
* Stage II, III, or IV malignant testicular GCT
* Stage II or III malignant ovarian GCT
* Stage I or II malignant extragonadal GCT
* Previously stage I gonadal patients who have relapsed on the low-risk (observation) stratum of this study(closed to accrual as of 01/20/10)
* Patients with immature teratoma or mature teratoma who relapse with a malignant component
* No patients with any of the following diagnoses:
* Stage IV ovarian and stage III-IV extragonadal GCT
* Intracranial GCT
* Pure mature or immature teratoma, pure dysgerminoma, or seminoma
* Patients with a non-germ cell component in their GCT (e.g., primitive neuroectodermal tumors or rhabdomyosarcoma)
* Alpha-fetoprotein and beta human chorionic gonadotropin tumor markers known
* If \> 5 days have elapsed from the time of obtaining original markers, tumor markers must be repeated before enrollment of low-risk patients and befor…
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.