A Phase III Study of En Bloc Versus Non-En Bloc Esophagectomy in Esophageal Cancer
Stopped early · Phase 3
Conditions studied: Esophageal Neoplasms
In brief
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 tumor in the esophagus (known as transthoracic en bloc esophagectomy) offers better control of the cancer than removing less tissue and lymph nodes (known as non-en bloc esophagectomy).
Key facts
- Study ID
- NCT00760604
- Run by
- Weill Medical College of Cornell University
- People needed
- 4
- Starts
- 2008-09-01
- Expected to finish
- 2012-04-01
- Last updated by the study team
- 2012-08-13
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Weill Medical College of Cornell Unversity — New York, New York, United States
Full record on ClinicalTrials.gov
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