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

September 25, 2008
August 10, 2012
September 2008
April 2012   (final data collection date for primary outcome measure)
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 ]
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: Yes ]
Complete list of historical versions of study NCT00760604 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Phase III Study of En Bloc Versus Non-En Bloc Esophagectomy in Esophageal Cancer
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).

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Esophageal Neoplasms
Procedure: Esophagectomy
Comparison of en-bloc vs. non-en bloc esophagectomy
  • 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.
    Intervention: Procedure: 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.
    Intervention: Procedure: Esophagectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
April 2012
April 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00760604
0806009855
No
Paul C. Lee, Weill Medical College of Cornell University
Weill Medical College of Cornell University
Not Provided
Principal Investigator: Paul C Lee, M.D. Weill Medical College of Cornell University
Weill Medical College of Cornell University
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP