40
Participants
Start Date
April 30, 2008
Primary Completion Date
September 30, 2009
Study Completion Date
September 30, 2009
Docetaxel
Docetaxel will be given at 60 mg/m2, as a 60-minute infusion every 3 weeks for 2 cycles before chemo-radiation. Four to five weeks after completion of chemo-radiation therapy, all patients will receive two more cycles of Docetaxel 60 mg/m2.
Cisplatin
Cisplatin will be given at 60 mg/m2, as 2-hour infusion every 3 weeks for 2 cycles before chemo-radiation. Four to five weeks after completion of chemo-radiation therapy, all patients will receive two more cycles of Cisplatin at 60 mg/m2.
Capecitabine
Capecitabine will be given orally at 1800 mg/m2 days 1 through 14 divided in two daily doses before chemo-radiation. Four to five weeks after completion of chemo-radiation therapy, all patients will receive two more cycles of Capecitabine at 1800 mg/m2 days 1 through 14 (divided in two daily doses).
Radiation
At the end of the second cycle of chemotherapy and one week of rest (day 27), a total of 45 Gy (1.8 Gy fx/d) of radiotherapy will be given.
Capecitabine
Capecitabine will be administered orally during radiotherapy for radiosensitization(1650 mg/m2 per day divided in two daily doses, 5 days/week, on Monday through Friday).
University Hospital of Crete Dept of Medical Oncology, 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
401 Military Hospital of Athens, Athens
Air Forces Military Hospital of Athens, Athens
General Hospital of Larissa Dept of Medical Oncology, Larissa
"Metaxa's Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology", Piraeus
Lead Sponsor
University Hospital of Crete
OTHER
Hellenic Oncology Research Group
OTHER