Esophagectomy:Three-field Versus Two-field Lymphadenectomy (ECTOP-2002)

NCT01807936 | Completed

• 1 other identifier: 2VS3E
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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 with radical lymphadenectomy remains the basic method of management of this malignancy. Lymph node metastasis is one of the most important factors in predicting the prognosis of patients with esophageal carcinoma, but the extent of lymph node dissection is still in debate, and there is no statistical evidence based on large scale prospective randomized trials with regard to the issue that which is the optimal extent of lymphadenectomy for esophageal cancer. The purpose of this study is to test two different extents of lymphadenectomy (Cervical-thoracic-upper abdominal three-field lymphadenectomy and Thoracic-upper abdominal two -field lymphadenectomy) in middle or lower third intrathoracic esophageal cancer. This research is being done to see whether one extent of lymphadenectomy is superior than the other with better long-term outcome and acceptable postoperative short-term outcome or not.

Conditions

Esophageal Neoplasms

Keywords

Esophageal Neoplasms; lymphadenectomy

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Participants will be seen at regular interval of 3 months the first year and every 6 months until death or the 3rd year.

  3 years.

Secondary Outcomes (1)

• Disease free survival

  3 years

Other Outcomes (2)

• postoperative morbidity and mortality

  an average of 2 weeks

• locoregional recurrence and recurrence pattern

  3 years

Study Arms (2)

Three-field lymphadenectomy

EXPERIMENTAL

Cervical-thoracic-upper abdominal three-field lymphadenectomy

Procedure: Lymphadenectomy

Two -field lymphadenectomy

NO INTERVENTION

Thoracic-upper abdominal two -field lymphadenectomy

Interventions

Lymphadenectomy PROCEDURE

Three-field lymphadenectomy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

• Li B, Hu H, Zhang Y, Zhang J, Miao L, Ma L, Luo X, Zhang Y, Ye T, Li H, Li Y, Shen L, Zhao K, Fan M, Zhu Z, Wang J, Xu J, Deng Y, Lu Q, Li H, Zhang Y, Pan Y, Liu S, Hu H, Shao L, Sun Y, Xiang J, Chen H. Three-field versus two-field lymphadenectomy in transthoracic oesophagectomy for oesophageal squamous cell carcinoma: short-term outcomes of a randomized clinical trial. Br J Surg. 2020 May;107(6):647-654. doi: 10.1002/bjs.11497. Epub 2020 Feb 28.

  PMID: 32108326 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Lymph Node Excision

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Haiquan Chen, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fudan University cancer hospital, Fudan University cancer hospital

Study Record Dates

• First Submitted: March 6, 2013
• First Posted: March 8, 2013
• Study Start: March 20, 2013
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2019
• Last Updated: July 20, 2023

Record last verified: 2023-07

Locations

CN (1)