Preoperative Chemotherapy vs. Chemoradiation in Esophageal / GEJ Adenocarcinoma

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

September 30, 2015

Primary Completion Date

August 31, 2023

Study Completion Date

August 31, 2023

Conditions
Esophageal CancerAdenocarcinoma, EsophagealAdenocarcinoma, Gastroesophageal Junction
Interventions
DRUG

(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)"

OTHER

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 ."

Trial Locations (3)

R3A 1R9

Health Sciences Centre / CancerCare Manitoba, Winnipeg

N6A 5W9

London Health Sciences Centre, London

Unknown

Toronto General Hospital / Princess Margaret Hospital, Toronto

All Listed Sponsors
collaborator

CancerCare Manitoba

OTHER

collaborator

University of Toronto

OTHER

collaborator

London Health Sciences Centre

OTHER

lead

Dr. Gordon Buduhan

OTHER