Status:
TERMINATED
A Phase III Study of En Bloc Versus Non-En Bloc Esophagectomy in Esophageal Cancer
Lead Sponsor:
Weill Medical College of Cornell University
Conditions:
Esophageal Neoplasms
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to test 2 different methods of surgery to remove cancer in the esophagus. This research is being done to see whether removing more tissue and lymph nodes surrounding the t...
Detailed Description
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 trans...
Eligibility Criteria
Inclusion
- Patients with cT2-T3/N0-N1-M1a-M1b(lymph node metastasis only) esophageal squamous cell and adenocarcinoma who have potentially resectable disease.
- Karnofsky performance status greater than or equal to 80%.
- Pulmonary and cardiac function must be acceptable for surgery according to institutional standards.
- Acceptable hepatic, renal and bone marrow function.
- Age 18 or older.
- Patients may receive preoperative chemotherapy and/or radiation therapy as part of their clinical care.
Exclusion
- Patients with clearly unresectable or metastatic esophageal cancer or clinical stage I esophageal cancer.
- Significant psychiatric illness that would interfere with patient compliance.
- Patients with any other serious underlying medical condition that would impair the ability of the patient to receive or comply with protocol treatment.
- Patients with a significant history of unstable cardiovascular disease (e.g., inadequately controlled hypertension, or angina; myocardial infarction within the previous 6 months; ventricular cardiac arrhythmias requiring medication; congestive heart failure that in the opinion of the treating physician should preclude the patient from protocol treatment.
- Uncontrolled diabetes mellitus or uncontrolled infection, including HIV or interstitial pneumonia or interstitial fibrosis.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00760604
Start Date
September 1 2008
End Date
April 1 2012
Last Update
August 13 2012
Active Locations (1)
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1
Weill Medical College of Cornell Unversity
New York, New York, United States, 10065