Status:
COMPLETED
Esophagectomy:Three-field Versus Two-field Lymphadenectomy (ECTOP-2002)
Lead Sponsor:
Fudan University
Conditions:
Esophageal Neoplasms
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-2002. Esophageal carcinoma is an aggressive disease with a poor prognosis. Surgical resection wit...
Detailed Description
Background : Esophageal carcinoma is an aggressive disease with a poor prognosis. Surgical resection with radical lymphadenectomy remains the basic method of management of this malignancy. The intern...
Eligibility Criteria
Inclusion
- Patients with histologically proven squamous cell esophageal cancer
- Patients with cT1-T3/N0-N1 mid or distal third (inferior to carina and 3cm superior to cardia ) operable esophageal lesion. Staging investigations including esophagogastroscopy, chest and abdominal CT scan, barium swallow and selective endoscopic ultrasonography showing no evidence of invading adjacent structure such as spine, bronchus, pericardium , descending aorta and without enlargement cervical and celiac nodes (diameter of short axis greater than 1.5cm) measured at CT scans.
- 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
Exclusion
- Patients with low performance status(Karnofsky score \<80%)
- Past history of malignancy
- Stage investigations indicating unresectable advanced disease(T4 or M1a,M1b)
- Patients with any other serious underlying medical condition that would impair the ability of the patient to receive or comply with protocol treatment
- Patients medically unfit for surgical resection
- Patients with pulmonary reserve inadequate to undergo thoracotomy and extensive mediastinal lymphadenectomy.
- Patients with a significant history of unstable cardiovascular disease 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.
- Significant psychiatric illness that would interfere with patient compliance
- Patients with severe hepatic cirrhosis or with serious renal disease unacceptable for surgery
- Patients considered of salvage surgery after definitive chemoradiotherapy
- Patients after neoadjuvant chemoradiotherapy
- Patients above the age of 75 years
- Patients unreliable for follow up
Key Trial Info
Start Date :
March 20 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2019
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT01807936
Start Date
March 20 2013
End Date
November 1 2019
Last Update
July 20 2023
Active Locations (1)
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1
Fudan University Cancer Center
Shanghai, Shanghai Municipality, China, 200032