A Phase 3 interventional study of bleomycin sulfate and carboplatin in Childhood Germ Cell Tumor, Extragonadal Germ Cell Tumor and Ovarian Cancer, sponsored by Children's Cancer and Leukaemia Group. Status unknown at 20 sites in 2 countries. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2013-09-17.
Sponsored by Children's Cancer and Leukaemia Group · Phase 3, Interventional, and Treatment
RATIONALE: Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. 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. Giving combination chemotherapy after surgery may kill any remaining tumor cells.
PURPOSE: This phase III trial is studying how well observation and/or combination chemotherapy works after surgery or biopsy in treating young patients with extracranial germ cell tumors.
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients who have not had prior biopsy or surgical resection undergo biopsy (if feasible) or surgical resection. Patients with mature or immature teratoma undergo observation. These patients who relapse (i.e., tumor regrowth) may undergo further surgical resection unless tumor markers are significantly elevated. If the tumor markers are significantly elevated, these patients proceed to JEB chemotherapy according to risk group. Patients with all other malignant germ cell tumors are assigned to 1 of 3 treatment groups according to risk.
PROJECTED ACCRUAL: A total of 105 patients will be accrued for this study.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 105 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Children's Cancer and Leukaemia Group is the lead sponsor of 44 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically* proven extracranial malignant germ cell tumor (GCT), including mature/immature teratoma, with or without elevated alpha-fetoprotein (AFP) or human chorionic gonadotropin (HCG) levels
Patients with relapsed or progressive extracranial malignant GCT allowed if previously treated with carboplatin, etoposide, and bleomycin (JEB) chemotherapy
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Event-free survival
Continuation of treatment
Development of common and follow-up strategies
Registration of all cases of mature and immature teratoma
This study is status unknown, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.
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Children's Cancer and Leukaemia Group