A Phase III Study of Accelerated versus Standard Chemotherapy for Patients with Intermediate- and Poor-Risk Metastatic Germ Cell Tumors

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Phase 3 Accelerated BEP Trial: A Randomised Phase 3 Trial of Accelerated versus Standard BEP Chemotherapy for Patients with Intermediate and Poor-Risk Metastatic Germ Cell Tumours (AGCT1532) (CIRB)

Purpose

The standard treatment for poor-risk and intermediate-risk germ cell tumors (GCTs), such as testicular cancer, is chemotherapy with the drugs bleomycin, etoposide, and cisplatin (abbreviated BEP) given every three weeks. In this study, researchers want to see if giving BEP chemotherapy every two weeks is more effective for controlling tumor growth than the standard regimen in patients with metastatic intermediate-risk and poor-risk GCTs.

A prior study has already shown that this accelerated treatment schedule did not cause more side effects than the standard schedule. Patients will be randomly assigned to receive one regimen of therapy or the other. BEP is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have intermediate-risk or poor-risk GCT of the testes, ovary, retroperitoneum, or mediastinum.
  • Patients may not have received prior chemotherapy or radiation therapy for metastatic cancer.
  • In addition to patients with good physical function, this study is also open to those who are capable of only limited self-care and are confined to bed or chair for more than half of their normal waking hours.
  • This study is for patients ages 11-45.

For more information about this study and to inquire about eligibility, please contact Dr. Darren R. Feldman at 646-888-4740.

Protocol

20-111

Phase

III

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator