A Phase III Study of En Bloc Versus Non-En Bloc Esophagectomy in Patients With Locally Advanced Esophageal Cancer
18 Years
85 Years
Both
Esophageal Neoplasms
Trial Information
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
years.
Inclusion Criteria:
- 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 Criteria:
- 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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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.
Outcome Time Frame:
CT scans will be performed every 6 months for 5 years.
Safety Issue:
No
Principal Investigator
Paul C Lee, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Weill Medical College of Cornell University
Authority:
United States: Institutional Review Board
Study ID:
0806009855
NCT ID:
NCT00760604
Start Date:
September 2008
Completion Date:
April 2012
Related Keywords:
- Esophageal Neoplasms
- Esophageal neoplasms
- Esophagectomy
- Neoplasms
- Esophageal Diseases
- Esophageal Neoplasms
Name | Location |
|---|---|
| Weill Medical College of Cornell Unversity | New York, New York 10065 |
