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
Nabil Adra, MD
Primary Investigator
Sandeep Batra, MD
Primary Investigator
Overview
The purpose of this study is to determine if accelerated BEP will be more effective but not significantly more toxic than standard BEP.
Description
The purpose of this study is to determine if accelerated BEP (Bleomycin, Etoposide, cisPlatin) is superior to standard BEP as first-line chemotherapy for intermediate and poor-risk metastatic GCTs.
Eligibility
You may be eligible for this study if you meet the following criteria:
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Conditions:
Germ Cell Tumor
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Age: Between 11 Years - 45 Years
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Gender: All
Inclusion Criteria
In order to be eligible to take part in this trial, patients must meet the following criteria:
- Age greater than/equal to 11 years and less than or equal to 45 years on the date of randomisation
- Histologically or cytologically confirmed germ cell tumour (non-seminoma or seminoma); or exceptionally raised tumour markers (AFP greater than/equal to 1000ng/mL and/or HCG greater than/equal to 5000 IU/L) without histologic or cytologic confirmation in the rare case where pattern of metastases consistent with GCT, high tumour burden, and a need to start therapy urgently.
For a full list of participation criteria, please visit clinicaltrials.gov.
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