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 States302 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 range21 Years
SexALL
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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…