A Phase III Study of En Bloc Versus Non-En Bloc Esophagectomy in Esophageal Cancer

August 10, 2012 updated by: Paul C. Lee, Weill Medical College of Cornell University

A Phase III Study of En Bloc Versus Non-En Bloc Esophagectomy in Patients With Locally Advanced Esophageal Cancer

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Weill Medical College of Cornell Unversity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
En bloc esophagectomy is performed through a transthoracic approach by removing the tumor-bearing esophagus, the pericardium anteriorly, both pleural surfaces laterally, as well as the thoracic duct and all other lymphoareolar tissue wedged posteriorly between the esophagus and the spine, and en-bloc resection of all nodal groups in the middle and lower mediastinum as well as the upper abdomen.
Procedure: Esophagectomy
Comparison of en-bloc vs. non-en bloc esophagectomy
Active Comparator: B
Transhiatal esophagectomy is performed through an abdominal incision and a neck incision. The stomach is mobilized, and the left gastric vessels are transected at its origin. Celiac lymph nodes are dissected, and the intrathoracic esophagus is dissected bluntly through the hiatus and through the neck. The cervical esophagus is divided at the level of the neck. After the esophagogastrectomy is performed, a gastric tube is created. An esophagogastrostomy is then performed in the neck. If a transthoracic approach is used, dissection will be as described for the transhiatal approach.
Procedure: Esophagectomy
Comparison of en-bloc vs. non-en bloc esophagectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: CT scans will be performed every 6 months for 5 years.
CT scans will be performed every 6 months for 5 years.

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine 5-year overall and disease-specific survival in arm A and arm B
Time Frame: CT scans every 6 months for 5 years
CT scans every 6 months for 5 years
To determine the rates of local and systemic recurrence in arm A vs. arm B
Time Frame: CT scans performed every 6 months for 5 years
CT scans performed every 6 months for 5 years
To determine time to progression in arm A vs. arm B
Time Frame: CT scans every 6 months for 5 years
CT scans every 6 months for 5 years
To determine mortality and morbidity in arm A vs. arm B
Time Frame: 5 years from the date of surgical resection
5 years from the date of surgical resection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Investigators

  • Principal Investigator: Paul C Lee, M.D., Weill Medical College of Cornell University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

September 25, 2008

First Submitted That Met QC Criteria

September 25, 2008

First Posted (Estimate)

September 26, 2008

Study Record Updates

Last Update Posted (Estimate)

August 13, 2012

Last Update Submitted That Met QC Criteria

August 10, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0806009855

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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