COG AGCT1532

Clinical Trial Title A Randomized Phase 3 Trial of Accelerated versus Standard BEP Chemotherapy for Patients with Intermediate and Poor-risk Metastatic Germ Cell Tumors
Trial Status Open to Enrollment
Start Date 02/01/2014
Location Randall Children's Hospital at Legacy Emanuel
Trial Type Pediatric Cancer (Oncology)
Specific Condition Germ Cell Tumor
Description This purpose of this phase III trial study is to determine whether accelerated BEP (bleomycin, etoposide, cisplatin) chemotherapy is more effective than standard BEP chemotherapy in participants with intermediate and poor-risk metastatic germ cell tumors.
Eligibility Criteria

Eligible Patients

  • Age ≥ 11 years and ≤ 50 years on the date of randomization
  • Histologically or cytologically confirmed germ cell tumor (non-seminoma or seminoma); or exceptionally raised tumor markers (AFP ≥ 1000ng/mL and/or HCG ≥ 5000 IU/L) without histologic or cytologic confirmation in the rare case where pattern of metastases consistent with GCT, high tumor burden, and a need to start therapy urgently
  • Primary arising in testis, ovary, retroperitoneum, or mediastinum
  • Metastatic disease or non-testicular primary
  • Intermediate or poor prognosis as defined by IGCCC classification3 (modified with different LDH criteria for intermediate risk non-seminoma, and inclusion of ovarian primaries).

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 | NCT02582697 | Accelerated v's Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours | 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