Clinical trial NCT00760604: A Phase III Study of En Bloc Versus Non-En Bloc Esophagectomy in Esophageal Cancer
Official title: A Phase III Study of En Bloc Versus Non-En Bloc Esophagectomy in Patients With Locally Advanced Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Esophageal Neoplasms
Keywords: Esophageal neoplasms
Esophagectomy
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2008-09-26
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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 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.

Primary outcomes:
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.
timeFrame: CT scans will be performed every 6 months for 5 years.
Secondary outcomes:
measure: To determine 5-year overall and disease-specific survival in arm A and arm B
timeFrame: CT scans every 6 months for 5 years
measure: To determine the rates of local and systemic recurrence in arm A vs. arm B
timeFrame: CT scans performed every 6 months for 5 years
measure: To determine time to progression in arm A vs. arm B
timeFrame: CT scans every 6 months for 5 years
measure: To determine mortality and morbidity in arm A vs. arm B
timeFrame: 5 years from the date of surgical resection
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Medical College of Cornell Unversity
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Paul C Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
References: