A Phase II Trial of Induction Chemotherapy With Epirubicin, Oxaliplatin and Fluorouracil (EOF) Followed by Esophagogastrectomy and Post-operative Concurrent Chemoradiotherapy With Fluorouracil and Cisplatin, in Patients With Loco-regionally Advanced Adenocarcinoma of the Esophagus, Gastroesophageal Junction and Gastric Cardia
- To assess the feasibility and tolerability of induction chemotherapy comprising
epirubicin hydrochloride, oxaliplatin, and fluorouracil (EOF), followed by surgical
resection and postoperative concurrent chemoradiotherapy comprising fluorouracil and
cisplatin in patients with locoregionally advanced adenocarcinoma of the esophagus,
gastroesophageal junction, or gastric cardia.
- To determine the rate of complete and partial response to three courses of EOF
- To compare the recurrence-free and overall survival of patients treated with this
regimen vs historical controls at this institution.
- To compare patterns of failure in patients treated with this regimen vs historical
controls at this institution.
- Induction chemotherapy: Patients receive epirubicin hydrochloride IV over 3-15 minutes
and oxaliplatin IV over 2 hours on day 1 and fluorouracil IV continuously on days 1-21.
Treatment repeats every 21 days for up to 3 courses in the absence of disease
progression or unacceptable toxicity.
- Surgery: Four weeks after completion of induction chemotherapy, patients with
locoregionally confined disease (T0-4, N0-1, M0-1a) undergo transthoracic
esophagogastrectomy or total gastrectomy with Roux-en-Y esophagojejunostomy, depending
on the location and extent of the tumor at the time of surgery.
- Postoperative chemoradiotherapy: Beginning 6-10 weeks after surgery, patients undergo
radiotherapy 5 days a week for approximately 6 weeks. Patients also receive
fluorouracil IV continuously and cisplatin IV continuously over 96 hours in weeks 1 and
4 of radiotherapy.
After completion of study treatment, patients are followed every 8-12 weeks for 3 years.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Feasibility of resectability rate
Prior experience at this institution suggests a resectability rate after induction chemoradiotherapy of 85-90%, primarily based on disease extent at the time of surgery. Resectability below 75% will suggest that this induction regimen is not feasible. Similarly, prior experience suggests that post-operative chemoradiotherapy can be given to between 70-80% of resected patients. If adjuvant chemoradiotherapy cannot be given to at least 65% of the resected patients on this trial, the feasibility of this schedule will be in doubt.
David J. Adelstein, MD
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
United States: Institutional Review Board
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center||Cleveland, Ohio 44195|