COG AGCT1531

Clinical Trial Title A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors
Trial Status Open to Enrollment
Start Date 05/25/2017
Location Randall Children's Hospital at Legacy Emanuel
Trial Type Pediatric Cancer (Oncology)
Specific Condition Childhood Extracranial Germ Cell Tumor Extragonadal Embryonal Carcinoma Germ Cell Tumor Malignant Germ Cell Tumor Malignant Ovarian Teratoma
Description 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.
Eligibility Criteria

Eligible Patients

  • 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).

Please contact Legacy's Cancer and Blood Disorders at Randall Children's Hospital at Legacy Emanuel for additional study inclusion/exclusion information.

 

 
IRB Number Central IRB
Notes Study Details | NCT03067181 | Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors | ClinicalTrials.gov
Principal Investigator Jason Glover, MD
Contact Name Cancer and Blood Disorders at Randall Children's Hospital at Legacy Emanuel
Contact Phone 503-276-9300
Contact Fax 503-276-9351
Contact E-Mail childcanc@LHS.ORG