A PROSPECTIVE RANDOMISED NON SURGICAL TREATMENT OF OESOPHAGEAL CANCER WITH COMBINED CHEMOTHERAPY AND EXTERNAL BEAM IRRADIATION WITH VS WITHOUT HIGH-DOSE BRACHYTHERAPY
OBJECTIVES: I. Compare the complete local remission rate in patients with unresectable stage
I, II, or III esophageal cancer treated with chemoradiotherapy with or without endoluminal
brachytherapy. II. Compare the complete remission rate (local, locoregional, and distant) in
these patients. III. Compare the overall and disease-free survival in these patients at 2
and 5 years after therapy. IV. Compare the toxicity and quality of life experienced by these
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center, tumor stage, and chemotherapy. All patients receive fluorouracil IV
continuously over 4 days (days 1-4) and/or cisplatin on day 2 of weeks 1 and 5. External
beam radiotherapy begins on day 1 of chemotherapy and is delivered in daily fractions, 5
days per week, for 5 weeks, followed by a cone down dose administered during week 6.
Patients randomized to brachytherapy (Iridium 192, high-dose rate) are treated on weeks 11
and 12 and receive 2 additional courses of chemotherapy at weeks 9 and 14. Patients
randomized to no brachytherapy receive additional chemotherapy courses on weeks 9 and 13.
Quality of life is assessed. Patients are followed every 6 months for 2 years and then
annually for 3 years years.
PROJECTED ACCRUAL: A total of 326 patients will be accrued for this study.
Allocation: Randomized, Primary Purpose: Treatment
Jean-Pierre Gerard, MD
Centre Hospitalier Lyon Sud
United States: Federal Government