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

Esophageal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00760604
• Other study ID #: 0806009855
• Status: Terminated
• Phase: Phase 3
• First received: September 25, 2008
• Last updated: August 10, 2012
• Start date: September 2008
• Est. completion date: April 2012

Study information

• Verified date: August 2012
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Neoplasms

Intervention

Procedure:
• Esophagectomy
Comparison of en-bloc vs. non-en bloc esophagectomy

Locations

Country	Name	City	State
United States	Weill Medical College of Cornell Unversity	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		CT scans will be performed every 6 months for 5 years.	No
Secondary	To determine 5-year overall and disease-specific survival in arm A and arm B		CT scans every 6 months for 5 years	No
Secondary	To determine the rates of local and systemic recurrence in arm A vs. arm B		CT scans performed every 6 months for 5 years	No
Secondary	To determine time to progression in arm A vs. arm B		CT scans every 6 months for 5 years	No
Secondary	To determine mortality and morbidity in arm A vs. arm B		5 years from the date of surgical resection	Yes