Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Esophagectomy: Sweet Versus Ivor-Lewis (ESVIL)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT01047111
First received: January 11, 2010
Last updated: February 26, 2013
Last verified: July 2012
  Purpose

Esophageal carcinoma is an aggressive disease with a poor prognosis. Surgical resection remains the basic method of management of this malignancy. Although different approaches have been described for the surgical resection of esophageal cancer, there is no statistical evidence based on large scale prospective randomized trials with regard to the issue that which is the optimal surgical approach for esophageal cancer. The purpose of this study is to test two different approach of transthoracic esophagectomy (Right Side Thoracotomy plus Midline Laparotomy Approach: Ivor-Lewis Procedure and Left Side Thoracotomy Approach: Sweet Procedure) in middle or lower third intrathoracic esophageal cancer. This research is being done to see whether one approach is superior than the other approach with better long-term outcome and acceptable postoperative short-term outcome or not.


Condition Intervention Phase
Esophageal Neoplasms
Procedure: Esophagectomy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase Ⅲ Study of Left Side Thoracotomy Approach (Sweet Procedure) Versus Right Side Thoracotomy Plus Midline Laparotomy Approach (Ivor-Lewis Procedure) Esophagectomy in Middle or Lower Third Intrathoracic Esophageal Cancer

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • Disease free survival [ Time Frame: Jan 2010-Jan 2016 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: Jan 2010-Jan 2016 ] [ Designated as safety issue: Yes ]
  • postoperative morbidity and mortality [ Time Frame: Jan 2010-Jan 2016 ] [ Designated as safety issue: Yes ]
  • Locoreginal recurrence and recurrence pattern [ Time Frame: Jan 2010-Jan 2016 ] [ Designated as safety issue: Yes ]
  • quality of life [ Time Frame: Jan 2010-Jan 2016 ] [ Designated as safety issue: No ]

Estimated Enrollment: 280
Study Start Date: May 2010
Estimated Study Completion Date: July 2016
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ivor-Lewis Procedure
Arm A: Esophagectomy was conducted through right side thoracotomy plus midline laparotomy approach:Ivor-Lewis Procedure.
Procedure: Esophagectomy
Esophagectomy Through Right Side Thoracotomy plus Midline Laparotomy Approach: Ivor-Lewis Procedure VS Esophagectomy Through Left Side Thoracotomy Approach: Sweet Procedure
Other Names:
  • Right side approach esophagectomy
  • Left side approach esophagectomy
Active Comparator: Sweet Procedure
Arm B: Esophagectomy was conducted through left side thoracotomy or thoracoabdominal incision: Sweet Procedure
Procedure: Esophagectomy
Esophagectomy Through Right Side Thoracotomy plus Midline Laparotomy Approach: Ivor-Lewis Procedure VS Esophagectomy Through Left Side Thoracotomy Approach: Sweet Procedure
Other Names:
  • Right side approach esophagectomy
  • Left side approach esophagectomy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01047111

Locations
China, Shanghai
Fudan University Cancer Center
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Haiquan Chen, MD Fudan University
  More Information

No publications provided

Responsible Party: Haiquan Chen MD, Fudan University Cancer Center
ClinicalTrials.gov Identifier: NCT01047111     History of Changes
Other Study ID Numbers: 201001ECFD
Study First Received: January 11, 2010
Last Updated: February 26, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Fudan University:
Esophageal Neoplasms
Esophagectomy

Additional relevant MeSH terms:
Esophageal Neoplasms
Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on November 23, 2014