Trial Information

A PROSPECTIVE RANDOMISED TRIAL OF INDUCTION CHEMOTHERAPY WITH 5-FU CONTINUOUS IV INFUSION AND CISPLATIN VERSUS SURGERY IN RESECTABLE ADENOCARCINOMA OF THE LOW THIRD OF THE ESOPHAGUS AND CARDIOESOPHAGEAL JUNCTION

OBJECTIVES:

- Compare survival in patients with operable adenocarcinoma of the lower third of the
esophagus or the cardia treated with fluorouracil/cisplatin vs. no chemotherapy prior
to surgical resection.

- Assess whether neoadjuvant fluorouracil/cisplatin increases tumor resectability.

OUTLINE: This study is randomized for neoadjuvant chemotherapy. Patients are stratified by
performance status, tumor location, and randomizing center.

Patients randomized to no neoadjuvant chemotherapy undergo resection of the tumor with
adequate margins and resection of regional lymph nodes (R2 with at least 8 nodal groups
recommended).

Patients randomized to neoadjuvant chemotherapy receive fluorouracil and cisplatin at 3-4
week intervals; fluorouracil is given by continuous intravenous infusion for 5 days and
cisplatin is given on the first 2 days of fluorouracil administration. Tumor response is
assessed after 2 courses; responding patients with no serious toxicity receive a third
course. Surgery, as above, is initiated 4-6 weeks after the second or third course of
chemotherapy. Upon recovery (within 3-6 weeks), patients who responded to neoadjuvant
chemotherapy receive 3-4 additional courses of postoperative chemotherapy (maximum total of
6 courses). Patients whose best response was stable disease are assessed for postoperative
radiotherapy.

Patients on either arm with positive resection margins, positive lymph nodes, or equivocal
complete resection are referred for postoperative radiotherapy. Further therapy for patients
with incomplete resection is at the discretion of the physician.

Patients are followed every 3-4 months for at least 5 years.

PROJECTED ACCRUAL: A total of 250 patients will be entered.