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

NCT ID: NCT00760604

Last Updated: 2012-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2012-04-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Esophageal Neoplasms

Keywords

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Esophageal neoplasms Esophagectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Esophagectomy

Intervention Type PROCEDURE

Comparison of en-bloc vs. non-en bloc esophagectomy

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.

Group Type ACTIVE_COMPARATOR

Esophagectomy

Intervention Type PROCEDURE

Comparison of en-bloc vs. non-en bloc esophagectomy

Interventions

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Esophagectomy

Comparison of en-bloc vs. non-en bloc esophagectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Paul C. Lee

Associate Professor of Cardiothoracic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paul C Lee, M.D.

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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Weill Medical College of Cornell Unversity

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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0806009855

Identifier Type: -

Identifier Source: org_study_id