Randomized Study of Pre-Operative Radio-Chemotherapy Versus Surgery Alone in Thoracic Esophageal Cancer Deemed to be Resectable
- Compare the overall survival of patients with resectable thoracic esophageal cancer
treated with neoadjuvant radio-chemotherapy and surgery versus surgery alone.
- Compare the disease-free survival of patients treated with these regimens.
- Compare the surgical mortality and morbidity of patients treated with these regimens.
- Compare the resectability of patients treated with these regimens.
- Determine the validation of new prognostic factors for survival of these patients
and/or the efficacy of this neoadjuvant treatment.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to histology (epidermoid carcinoma vs adenocarcinoma vs undifferentiated
carcinoma), stage (I vs IIA vs IIB), tumor location (above the carina vs below the carina),
and participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo radiotherapy daily 5 days a week for 5 weeks. Patients receive
fluorouracil IV continuously on days 1-4 and 29-32 and cisplatin IV on days 1 or 2 and
29 or 30 (or a lower dose on days 1-5 and 29-33). Within 4-8 weeks after completion of
radio-chemotherapy, patients undergo surgical resection.
- Arm II: Patients undergo surgical resection. Patients are followed every 4 months for 2
years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 380 patients (190 per treatment arm) will be accrued for this
study within 3 years.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
J. P. Triboulet
Centre Hospitalier Regional et Universitaire de Lille
United States: Federal Government