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

This study has been terminated.
(Closed due to slow patient accrual.)
Sponsor:
Information provided by (Responsible Party):
Paul C. Lee, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00760604
First received: September 25, 2008
Last updated: August 10, 2012
Last verified: August 2012
  Purpose

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).


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 En Bloc Versus Non-En Bloc Esophagectomy in Patients With Locally Advanced Esophageal Cancer

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To determine time to progression in arm A vs. arm B [ Time Frame: CT scans every 6 months for 5 years ] [ Designated as safety issue: No ]
  • To determine mortality and morbidity in arm A vs. arm B [ Time Frame: 5 years from the date of surgical resection ] [ Designated as safety issue: Yes ]

Enrollment: 4
Study Start Date: September 2008
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00760604

Locations
United States, New York
Weill Medical College of Cornell Unversity
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Paul C Lee, M.D. Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Paul C. Lee, Associate Professor of Cardiothoracic Surgery, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00760604     History of Changes
Other Study ID Numbers: 0806009855
Study First Received: September 25, 2008
Last Updated: August 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell 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 October 21, 2014