Spots Global Cancer Trial Database for Accelerated v's Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours
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Trial Identification
Brief Title: Accelerated v's Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours
Official Title: Phase 3 Accelerated BEP: A Randomised Phase 3 Trial of Accelerated Versus Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours
Study ID: NCT02582697
Conditions
Study Description
Brief Summary: The purpose of this study is to determine whether accelerated BEP chemotherapy is more effective than standard BEP chemotherapy in males with intermediate and poor-risk metastatic germ cell tumours.
Detailed Description: Bleomycin, Etoposide, Cisplatin (BEP) administered 3-weekly x 4 remains standard 1st line chemotherapy for intermediate- and poor-risk metastatic germ cell tumours (GCTs). Cure rates are over 90% for good-risk disease, 85% with intermediate-risk, and about 70% for poor-risk disease. Previous strategies to improve first-line chemotherapy have failed to improve cure rates and were more toxic than BEP. New strategies are needed for patients with intermediate and poor-risk disease. BEP is accelerated by cycling Cisplatin and etoposide 2-weekly instead of 3-weekly. The Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) is conducting a trial comparing accelerated BEP with standard BEP. The aim of this study is to determine if accelerated BEP is superior to standard BEP as first-line chemotherapy for intermediate and poor risk metastatic GCTs.
Eligibility
Minimum Age: 11 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Memorial Sloan Kettering Cancer Centre, New York, New York, United States
Calvary Mater Newcastle, Newcastle, New South Wales, Australia
Royal North Shore Hospital, St Leonards, New South Wales, Australia
Prince of Wales Hospital, Sydney, New South Wales, Australia
Chris O'Brien Lifehouse, Sydney, New South Wales, Australia
Macquarie Cancer Clinical Trials, Sydney, New South Wales, Australia
Concord Repatriation General Hospital, Sydney, New South Wales, Australia
Westmead Hospital, Sydney, New South Wales, Australia
Nepean Hospital, Sydney, New South Wales, Australia
Tweed Hospital, Tweed Heads, New South Wales, Australia
SAN Clinical Trials Unit, Wahroonga, New South Wales, Australia
Royal Brisbane & Women's Hospital, Brisbane, Queensland, Australia
Queensland Children's Hospital, South Brisbane, Queensland, Australia
Princess Alexandra, Woolloongabba, Queensland, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Flinders Medical Centre, Bedford Park, South Australia, Australia
Royal Hobart Hospital, Hobart, Tasmania, Australia
Box Hill Hospital, Box Hill, Victoria, Australia
Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia
Austin Health, Heidelberg, Victoria, Australia
Sunshine Hospital, St Albans, Victoria, Australia
Border Medical Oncology, Wodonga, Victoria, Australia
Fiona Stanley Hospital, Murdoch, Western Australia, Australia
Starship Children's Hospital, Grafton, Auckland, New Zealand
Auckland Hospital, Grafton, Auckland, New Zealand
Palmerston North Hospital, Roslyn, Palmerston North, New Zealand
Christchurch Hospital, Christchurch, , New Zealand
Dunedin Hospital, Dunedin, , New Zealand
Contact Details
Name: Peter Grimison
Affiliation: Chris O'Brien Lifehouse
Role: STUDY_CHAIR
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