650
Participants
Start Date
October 31, 2007
Primary Completion Date
December 31, 2013
Study Completion Date
December 31, 2013
Docetaxel
ARM A: Docetaxel 75 mg/m2 as an IV infusion over 1h on day 1 every 2 weeks for 4 cycles ARM B: Docetaxel 75 mg/m2 as an IV infusion over 1h on day 1 every 3 weeks for 6 cycles
Epirubicin
ARM A: Epirubicin 75 mg/m2 IV push on day 1 every 2 weeks for 4 cycles
Cyclophosphamide
ARM A: Cyclophosphamide 500 mg/m2 IV push on day 1 every 2 weeks for 4 cycles ARM B: Cyclophosphamide 600 mg/m2 IV push on day 1 every 3 weeks for 6 cycles
5-fluoruracil
ARM A: 5-fluoruracil 500 mg/m2 IV push on day 1 every 2 weeks for 4 cycles
Granulocyte-colony stimulating growth factor
rhG-CSF 5 μg/kg/d on days 3-10 after each cycle
University Hospital of Crete, Heraklion
University General Hospital of Alexandroupolis, Dep of Medical Oncology, Alexandroupoli
"IASO General Hospital of Athens, 1st Dep of Medical Oncology", Athens
"Laikon General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine", Athens
"Marika Iliadis Hospital of Athens, Dep of Medical Oncology", Athens
401 Military Hospital of Athens, Athens
Air Forces Military Hospital of Athens, Athens
State General Hospital of Larissa, Dep of Medical Oncology, Larissa
"Metaxa's Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology", Piraeus
"Theagenion Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology", Thessaloniki
Lead Sponsor
University Hospital of Crete
OTHER
Hellenic Oncology Research Group
OTHER