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

Study of Accelerated vs. Standard Chemotherapy for Metastatic Germ Cell Tumors

Recruiting
11 years - 45 years
All
1 Location

Brief description of study.

The purpose of this study is to determine if accelerated BEP will be more effective but not significantly more toxic than standard BEP.

Detailed description of study

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 of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Germ Cell Tumor
  • Age: 11 years - 45 years
  • 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.

Updated on 19 Feb 2024. Study ID: 1902750740 (1808832730) (PHO-COG-AGCT1532)

This study investigates the effectiveness of an accelerated chemotherapy regimen compared to the standard regimen for treating metastatic germ cell tumors (GCTs). Germ cell tumors are a type of cancer that begins in the cells that form sperm or eggs. The study aims to see if the accelerated treatment is more effective without being more toxic than the standard treatment.

Participants will be randomly assigned to one of two study arms. One arm will receive the accelerated chemotherapy regimen, while the other will receive the standard regimen. Chemotherapy involves using drugs to kill cancer cells, and the study will monitor the effectiveness and side effects of each treatment.

  • Who can participate: Participants must be between 11 and 45 years old. They must have a confirmed diagnosis of germ cell tumor or certain high tumor marker levels indicating GCT.
  • Study details: Participants will be assigned to either an accelerated or standard chemotherapy regimen. The study will compare the effectiveness and side effects of the two regimens.

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