500
Participants
Start Date
February 28, 2014
Primary Completion Date
December 31, 2029
Study Completion Date
December 31, 2029
Bleomycin (active name: Bleomycin Sulfate)
"Standard Arm: Bleomycin 30,000 international units IV weekly for 3 doses (eg. days 1, 8 and 15 or days 2, 9 and 16 of a 21-day cycle) for 4 cycles.~Accelerated Arm: Bleomycin 30,000 international units IV weekly for 2 doses (eg. days 1 and 8 or days 2 and 9 of a 14-day cycle) for 4 cycles. Followed by Bleomycin 30,000 international units IV weekly for 4 doses."
Etoposide
"Standard Arm: Etoposide 100 mg/m2 IV on days 1, 2, 3, 4, 5 of a 21-day cycle for 4 cycles.~Accelerated Arm: 100 mg/m2 IV on days 1, 2, 3, 4, 5 of a 14-day cycle for 4 cycles."
Cisplatin
"Standard Arm: Cisplatin 20 mg/m2 IV on days 1, 2, 3, 4, 5 of a 21-day cycle for 4 cycles.~Accelerated Arm: Cisplatin 20 mg/m2 IV on days 1, 2, 3, 4, 5 of a 14-day cycle for 4 cycles."
Pegylated G-CSF (Pegfilgrastim)
Standard Arm: 6 mg SCI on day 6 of a 21-day cycle for 4 cycles. Accelerated Arm: 6 mg SCI on day 6 of a 14-day cycle for 4 cycles.
Filgrastim
"Standard Arm: 10 mcg/kg/day on day6, until post-nadir absolute neutrophil count ≥ 1.0 x 10\^9/L, of a 21-day cycle for 4 cycles.~Accelerated Arm: 10 mcg/kg/day on day 6, until post-nadir absolute neutrophil count ≥ 1.0 x 10\^9/L, of a 14-day cycle for 4 cycles."
RECRUITING
Starship Children's Hospital, Grafton
RECRUITING
Auckland Hospital, Grafton
RECRUITING
Prince of Wales Hospital, Sydney
RECRUITING
Chris O'Brien Lifehouse, Sydney
RECRUITING
Royal North Shore Hospital, St Leonards
RECRUITING
SAN Clinical Trials Unit, Wahroonga
RECRUITING
Macquarie Cancer Clinical Trials, Sydney
RECRUITING
Concord Repatriation General Hospital, Sydney
WITHDRAWN
Westmead Hospital, Sydney
RECRUITING
Calvary Mater Newcastle, Newcastle
RECRUITING
Tweed Hospital, Tweed Heads
RECRUITING
Nepean Hospital, Sydney
RECRUITING
Peter MacCallum Cancer Centre, East Melbourne
WITHDRAWN
Sunshine Hospital, St Albans
RECRUITING
Austin Health, Heidelberg
RECRUITING
Box Hill Hospital, Box Hill
RECRUITING
Border Medical Oncology, Wodonga
RECRUITING
Royal Brisbane & Women's Hospital, Brisbane
RECRUITING
Queensland Children's Hospital, South Brisbane
RECRUITING
Princess Alexandra, Woolloongabba
RECRUITING
Palmerston North Hospital, Roslyn
RECRUITING
Royal Adelaide Hospital, Adelaide
ACTIVE_NOT_RECRUITING
Flinders Medical Centre, Bedford Park
RECRUITING
Fiona Stanley Hospital, Murdoch
RECRUITING
Royal Hobart Hospital, Hobart
RECRUITING
Christchurch Hospital, Christchurch
WITHDRAWN
Dunedin Hospital, Dunedin
RECRUITING
Memorial Sloan Kettering Cancer Centre, New York
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
OTHER
Cambridge University Hospitals NHS Foundation Trust
OTHER
Cancer Trials Ireland
NETWORK
Children's Oncology Group
NETWORK
Dana-Farber Cancer Institute
OTHER
University of Southern California
OTHER
University of Sydney
OTHER