Children's Oncology Group
This phase III trial studies how well active surveillance help doctors to monitor subjects with low risk germ cell tumors for recurrence after their tumor is removed. When the germ cell tumor has spread outside of the organ in which it developed, it is considered metastatic. Chemotherapy drugs, such as bleomycin, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The trial studies whether carboplatin or cisplatin is the preferred chemotherapy to use in treating metastatic standard risk germ cell tumors.
PRIMARY OBJECTIVES: I. To evaluate whether a strategy of complete surgical resection followed by surveillance can maintain an overall survival rate of at least 95.7% at two years for pediatric, adolescent and adult patients with stage I (low risk) malignant germ cell tumors (Stratum 2), and at least 88% for patients with all stage/grade ovarian pure immature teratoma (Stratum 1). II. To compare the event-free survival of a carboplatin versus (vs.) cisplatin-based regimen in the treatment of pediatric, adolescent and young adult patients with standard risk non-seminomatous germ cell tumors.…
Inclusion Criteria: * There is no age limit for the low risk stratum (stage I ovarian immature teratoma and stage I non-seminoma or seminoma malignant GCT \[all sites\]) * Standard risk 1: Patients must be \< 11 years of age at enrollment * Standard risk 2: Patients must be \>= 11 and \< 25 years of age at enrollment * Patients enrolling on one of the low risk arms must be newly diagnosed with a stage I germ cell tumor; for the standard risk arms, patients must be newly diagnosed with malignant germ cell tumor (stage II or higher). * Histologic confirmation of a primary extracranial germ c…
Undergo observation
Undergo a tumor biopsy
Undergo blood sample collection
Given IV
Given IV
Given IV
Undergo a CT scan
Given IV
Undergo MRI
Undergo a pulmonary function test
Ancillary studies