29
Participants
Start Date
September 30, 2015
Primary Completion Date
August 31, 2023
Study Completion Date
August 31, 2023
(Epirubicin Cisplatin 5-Fluorouracil / Xeloda) OR 5-Fluorouracil Leucovorin Oxaliplatin Docetaxel
"NEOADJUVANT CHEMOTHERAPY (OPTION of CHEMO REGIMEN 1 or 2)~1\) FLOT - Four x 14 day cycles FLOT preoperatively and 4 cycles postoperatively (within 4-10 weeks after surgery): 5-Fluorouracil 2600 mg/m², day 1 IV every 14 days Leucovorin 200 mg/m², day 1, IV., every 14 days Oxaliplatin 85 mg/m², day 1, IV, every 14 days Docetaxel 50mg/m2, day 1, IV, every 14 days~2\) ECF / ECX - Three x 21-day cycles ECF preoperatively and 3 cycles postoperatively (within 4-10 weeks after surgery): Epirubicin (50 mg/m²,mg per square meter of body-surface area) by intravenous bolus on day 1 IV Cisplatin: 60 mg/m², mg per square meter intravenously with hydration on day 1 IV 5-Fluorouracil: 200 mg/m², mg per square meter daily for 21 days by continuous IV infusion 5-FU may be substituted with Capecitabine (Xeloda) 625mg/m2, PO BID (ECX)"
Carboplatin paclitaxel plus concurrent radiotherapy
"5 cycles carboplatin and paclitaxel given on days 1, 8, 15, 22 and 29 preoperatively:~* paclitaxel: 50 mg / m2 IV over 1 hour~* carboplatin: dosed to an area under the curve of 2, by Calvert formula, as a 1 hour IV infusion~Radiation Therapy Concurrent radiation therapy will begin within 24 hours of initiation of chemotherapy for patients randomized to chemoradiation treatment.~1\. Dose specifications:~1. Phase 1: Total radiation prescription dose 45 Gy given in 25 fractions of 1.8 Gy per fraction, 5 fractions / week, one treatment / day, starting on the first day of first cycle of chemotherapy. This total radiation dose option is acceptable if boost dose is not possible due to clinical reasons or dosimetric constraints.~2. Phase 2: (GTV only) Boost is not mandatory and up to the discretion of radiation oncologist. Total radiation prescription dose 5.4 Gy given in 3 fractions of 1.8 Gy per fraction, 5 fractions / week, one treatment ."
Health Sciences Centre / CancerCare Manitoba, Winnipeg
London Health Sciences Centre, London
Toronto General Hospital / Princess Margaret Hospital, Toronto
Collaborators (2)
CancerCare Manitoba
OTHER
University of Toronto
OTHER
London Health Sciences Centre
OTHER
Dr. Gordon Buduhan
OTHER