Trial Information

A Prospective Randomized Phase III Trial Comparing Trimodality Therapy (Cisplatin, 5-FU, Radiotherapy, and Surgery) to Surgery Alone for Esophageal Cancer

OBJECTIVES: I. Compare overall five-year survival rates and treatment failures in patients
receiving neoadjuvant cisplatin (CDDP) plus fluorouracil (5-FU) with concomitant
radiotherapy followed by surgical resection versus patients receiving surgery alone. II.
Assess and compare the toxicities of each approach. III. Compare the incidence and pattern
of local (gastric or esophageal bed or regional lymph nodes) and distant (supraclavicular
lymph node, liver, peritoneal carcinomatosis, or lung, brain, etc.) recurrence. IV. Evaluate
the prognostic ability of noninvasive and minimally invasive pretreatment staging with
regard to survival and recurrence. V. Evaluate the ability of preresection adjuvant
chemotherapy with concomitant radiation therapy to render tumors to lower stages. VI.
Evaluate the impact of lymph nodes on survival and recurrence.

OUTLINE: This a two arm, randomized study. Patients are stratified by: cell type of cancer
(squamous cell vs adenocarcinoma); lymph nodes (positive vs negative); and stage (invasive
vs noninvasive). Patients in arm I undergo chemotherapy and radiotherapy within 24 hours of
each other. Chemotherapy consists of cisplatin (CDDP) by bolus IV infusion over 30 minutes
on day 1 and again on day 29. Fluorouracil (5-FU) is administered by continuous IV infusion
for 4 days (on days 1-4 and 29-32) after completion of cisplatin. Radiotherapy is
administered on days 1-5, 8-12, 15-19, 22-26, and 29-33, with a boost on days 36-38. If
there is no disease progression or unresectable disease, surgery is performed within 3-8
weeks following completion of therapy. Patients in arm II undergo surgery alone no later
than 6 weeks postrandomization. Patients are followed at least every 3 months for two years,
then every 6 months for the next two years, and annually thereafter.

PROJECTED ACCRUAL: There will be 500 patients accrued into this study within 5 years.