Trial Information

A RANDOMISED, CONTROLLED TRIAL OF PRE- AND POST-OPERATIVE CHEMOTHERAPY IN PATIENTS WITH OPERABLE GASTRIC CANCER

OBJECTIVES:

- Compare the survival and quality of life of patients with resectable stage II or III
adenocarcinoma of the stomach treated with epirubicin, cisplatin, and fluorouracil
before and after resection vs resection alone.

- Determine the effect of perioperative chemotherapy on the resectability of gastric
cancer in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by center and
performance status (0 vs 1).

- Arm I: Patients undergo radical total gastrectomy or radical subtotal distal
gastrectomy, at the discretion of the surgeon, with perigastric lymph node dissection.
Patients also may undergo lymphadenectomy at the discretion of the surgeon. At the
beginning of the laparotomy, a pre-aortic, infra-colic node is sampled for staging
purposes and frozen sections are examined during surgery. Patients who are found to
have metastatic disease undergo palliative resection at the discretion of the surgeon
and postoperative chemotherapy at the discretion of the oncologist.

- Arm II: Patients receive fluorouracil (5-FU) IV continuously for 3 weeks and cisplatin
IV over 4 hours (beginning 4 hours after initiation of 5-FU infusion) and epirubicin IV
on day 1 (ECF). Treatment continues every 3 weeks for 3 courses. Within 6 weeks after
completion of course 3 and when blood counts recover, patients undergo resection as in
arm I. Beginning within 4-6 weeks after surgery, patients receive 3 additional courses
of ECF.

Quality of life is assessed at baseline, at completion of study therapy, and then every 6
months for 2 years.

Patients are followed every 6 months for 2 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study within 4 years.