P3BEP – ANZUP

Current Clinical Trials

Phase III Accelerated BEP Trial

Testicular — Recruiting

The current gold standard practice for the treatment of germ cell tumours is the use of a chemotherapy combination called BEP which consists of three chemotherapy agents, Bleomycin, Etoposide and Cisplatin administered on a 3 weekly cycle. BEP is given with a drug called pegylated G-CSF (or pegfilgrastim) which stimulates white blood cell production. The purpose of this study is to determine whether giving the same dose of BEP on a 2-weekly schedule will be more effective than a 3-weekly schedule and will be well tolerated. The 2-weekly schedule is called ‘accelerated BEP’.

If you think this trial might be right for you, please ask your doctor.

TRIAL TITLE

Accelerated versus standard BEP chemotherapy for patients with intermediate and poor-risk metastatic germ cell tumours: a randomised phase III trial

CONSUMER TITLE

Study testing whether giving standard chemotherapy more frequently (“accelerated” treatment) improves outcomes for people with advanced testicular cancer. Participants are randomly assigned to different treatment groups.

CANCER TYPE

Testicular

TRIAL STATUS

Recruiting

PROTOCOL NUMBER

ANZUP 1302

CO-ORDINATING CENTRE

NHMRC Clinical Trials Centre

STUDY CHAIR

Prof Peter Grimison

PATIENT POPULATION

Patients aged 11 to 45 years with intermediate or poor-risk advanced germ cell tumours requiring first-line chemotherapy

RECRUITMENT TARGET

Stage 1: 150 patients Stage 2: 350 patients

ACKNOWLEDGEMENT

This investigator-initiated study is being led by ANZUP in collaboration with the NHMRC Clinical Trials, the Children’s Oncology Group, Cambridge Clinical Trials Centre and the Australian and New Zealand Children’s Haematology/Oncology Group (ANZCHOG). ANZUP receives valuable infrastructure support from the Australian Government through Cancer Australia. Special thanks also to the Clinical Trials Awards and Advisory Committee (UK) and National Cancer Institute (USA) for funding this study.