Study Comparing Accelerated and Standard BEP Chemotherapy for Men with Advanced Germ Cell Tumors
Sponsor: University of Sydney
ClinicalTrials ID:NCT02582697
This clinical trial is exploring whether a faster schedule of BEP chemotherapy is more effective than the standard schedule for treating men with advanced germ cell tumors that have spread and are considered intermediate or poor-risk.
Patient Parameters
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Program Overview
The study aims to find out if a faster version of BEP chemotherapy, which includes the drugs Bleomycin, Etoposide, and Cisplatin, is better than the standard version for treating men with advanced germ cell tumors. The standard treatment is given every three weeks, but the accelerated version is given every two weeks. Researchers want to see if the faster treatment can improve cure rates for patients with intermediate and poor-risk tumors, as current cure rates are lower for these groups compared to those with good-risk tumors.
Description
The standard treatment for advanced germ cell tumors is BEP chemotherapy, given every three weeks. This treatment works well for good-risk tumors, but less so for intermediate and poor-risk tumors. This study is testing a faster version of BEP, given every two weeks, to see if it can improve outcomes for these patients. The trial is being conducted by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) and aims to determine if the accelerated treatment is more effective as a first-line therapy for men with intermediate and poor-risk metastatic germ cell tumors.
Eligibility Criteria
Inclusion Criteria
- Men aged 11 to 50 years.
- Confirmed diagnosis of germ cell tumor, or very high tumor markers indicating germ cell tumor.
- Tumor started in the testis, ovary, retro-peritoneum, or mediastinum.
- Cancer has spread or is not in the testis.
- Classified as intermediate or poor prognosis based on specific criteria.
- Good bone marrow, liver, and kidney function based on blood tests.
- Able to start treatment within 14 days of joining the study.
- Willing to follow all study requirements and provide written consent.
Exclusion Criteria
- Other types of cancer, except for certain skin cancers or germ cell tumors treated over 5 years ago.
- Previous chemotherapy or radiotherapy, with some exceptions for specific cases.
- Heart or lung conditions that prevent safe treatment.
- Nerve damage or hearing issues.
- Serious infections or other illnesses that could affect treatment safety.
- Inadequate contraception; men must use two effective methods during and after treatment.
- Allergies to study drugs.
- Conditions that would make it hard to follow the study plan, such as substance abuse.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Memorial Sloan Kettering Cancer Centre | 10065 | New York | New York |
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