A Phase III Study of En Bloc Versus Non-En Bloc Esophagectomy in Patients With Locally Advanced Esophageal Cancer
The aim of this study is to determine the 5-year disease-free survival, overall survival,
and time to progression comparing (Arm A) transthoracic en bloc esophagectomy and (Arm B)
transhiatal or transthoracic non-en bloc esophagectomy. Randomization to the two surgical
arms will take place after the patient has given written informed consent and eligibility
has been established. Patients will be informed of their randomized arm prior to the day of
surgery. Preoperative chemotherapy may be administered at the discretion of the treating
physician. Adjuvant chemotherapy and/or radiotherapy will be prescribed at the discretion
of the treating physician. All patients will be followed for recurrence and survival for 5
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease free survival defined as the time from surgical resection to the time of recurrent disease, death from esophageal cancer, or death from any cause.
CT scans will be performed every 6 months for 5 years.
Paul C Lee, M.D.
Weill Medical College of Cornell University
United States: Institutional Review Board
|Weill Medical College of Cornell Unversity||New York, New York 10065|