Esophagectomy in Treating Patients With High-Grade Dysplasia of the Esophagus or Stage I, Stage II, or Stage III Esophageal Cancer

Esophageal Cancer Clinical Trial

Official title:

Minimally Invasive Esophagectomy (MIE): A Multicenter Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00063986
• Other study ID #: CDR0000305866
• Secondary ID: U10CA021115E2202
• Status: Completed
• Phase: Phase 2
• Start date: June 24, 2004
• Est. completion date: August 2012

Study information

• Verified date: June 2023
• Source: Eastern Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Laparoscopic-assisted surgery and video-assisted thoracoscopy are less invasive types of surgery for esophageal cancer that may have fewer side effects and improve recovery.

PURPOSE: This phase II trial is studying how well laparoscopic-assisted surgery and video-assisted thoracoscopy work in treating patients who are undergoing esophagectomy for high-grade dysplasia of the esophagus or stage I, stage II, or stage III esophageal cancer.

Description:

OBJECTIVES:

• Determine the feasibility of performing minimally invasive esophagectomy (MIE), in terms of 30-day mortality, in patients with high-grade dysplasia of the esophagus or stage I-III esophageal cancer.

• Determine the complications associated with this procedure in these patients.

• Determine the rate at which conversion to open operation is required in patients undergoing this procedure.

• Determine the length of the operation, duration of intensive care unit stay, and length of hospital stay in patients undergoing this procedure.

• Determine feasibility and conversion rate of MIE after neoadjuvant therapy.

• Assess the effectiveness of lymph node dissection by MIE by recording the total number of lymph nodes dissected.

• Assess outcomes at follow-up to three years.

OUTLINE: This is a multicenter study.

Patients undergo minimally invasive esophagectomy comprising video-assisted thoracoscopy to mobilize the thoracic esophagus in combination with laparoscopy to complete the esophagectomy and a neck incision to mobilize the cervical esophagus. Mortality at 30 days is assessed.

Patients are followed every 3 months for 2 years and then every 6 months for 1 year.

ACTUAL ACCRUAL: A total of 110 patients were accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: August 2012
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

INCLUSION CRITERIA:

DISEASE CHARACTERISTICS:

• High grade dysplasia of the esophagus who would undergo esophagectomy OR esophageal cancer at stage T1-T3, N0-N1 who require esophagectomy (patients with M1 disease and/or bulky lymph node involvement were excluded).

• Pathological confirmation of a diagnosis of cancer or high-grade dysplasia of the esophagus by biopsy.

• Computerized tomography (CT) scan of chest and abdomen within 6 weeks prior to registration

• Stomach must be available for conduit

• Age of 18 and over

• ECOG performance status of 0-2

• Creatinine less than 2 mg/dL

• Patients with esophageal cancer who would be treated with neoadjuvant chemotherapy and/or radiation were eligible. If patients were registered prior to receiving neoadjuvant chemotherapy they were allowed up to 5 months to complete therapy and any restaging that was necessary before operation was performed.

• The patient was considered an appropriate candidate for surgery based on preoperative clinical staging and physiological factors prior to registration as documented in the surgical plan. Pre-operative staging should include:

• Endoscopic ultrasound (EUS)

• Positron emission tomography (PET) scan and/or laparoscopic staging (Laparoscopic staging could be performed on the day of resection. Additional evaluation was recommended if the PET scan suggested distant metastatic disease.)

EXCLUSION CRITERIA:

• Cancer extending into the stomach more than 20%

• Prior anti-reflux or gastric operations

• Prior right thoracotomy

• Prior major neck operation other than the removal of superficial skin lesion

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Procedure:
• Minimally invasive esophagectomy (MIE)
Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.

Locations

Country	Name	City	State
United States	Mary Rutan Hospital	Bellefontaine	Ohio
United States	Boston University Cancer Research Center	Boston	Massachusetts
United States	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Adena Regional Medical Center	Chillicothe	Ohio
United States	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center	Columbus	Ohio
United States	CCOP - Columbus	Columbus	Ohio
United States	Doctors Hospital at Ohio Health	Columbus	Ohio
United States	Grant Medical Center Cancer Care	Columbus	Ohio
United States	Mount Carmel Health - West Hospital	Columbus	Ohio
United States	Riverside Methodist Hospital Cancer Care	Columbus	Ohio
United States	Medical City Dallas Hospital	Dallas	Texas
United States	Geisinger Cancer Institute at Geisinger Health	Danville	Pennsylvania
United States	Grady Memorial Hospital	Delaware	Ohio
United States	Hutchinson Area Health Care	Hutchinson	Minnesota
United States	Fairfield Medical Center	Lancaster	Ohio
United States	Meeker County Memorial Hospital	Litchfield	Minnesota
United States	HealthEast Cancer Care at St. John's Hospital	Maplewood	Minnesota
United States	Strecker Cancer Center at Marietta Memorial Hospital	Marietta	Ohio
United States	Hennepin County Medical Center - Minneapolis	Minneapolis	Minnesota
United States	Masonic Cancer Center at University of Minnesota	Minneapolis	Minnesota
United States	Virginia Piper Cancer Institute at Abbott - Northwestern Hospital	Minneapolis	Minnesota
United States	Mount Sinai Medical Center	New York	New York
United States	Licking Memorial Cancer Care Program at Licking Memorial Hospital	Newark	Ohio
United States	Alegant Health Cancer Center at Bergan Mercy Medical Center	Omaha	Nebraska
United States	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska
United States	Creighton University Medical Center	Omaha	Nebraska
United States	Immanuel Medical Center	Omaha	Nebraska
United States	Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center	Orange	California
United States	UPMC Cancer Centers	Pittsburgh	Pennsylvania
United States	HealthEast Cancer Care at St. Joseph's Hospital	Saint Paul	Minnesota
United States	Regions Hospital Cancer Care Center	Saint Paul	Minnesota
United States	Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center	Savannah	Georgia
United States	St. Francis Cancer Center at St. Francis Medical Center	Shakopee	Minnesota
United States	Community Hospital of Springfield and Clark County	Springfield	Ohio
United States	Mercy Medical Center	Springfield	Ohio
United States	Geisinger Medical Group - Scenery Park	State College	Pennsylvania
United States	Mount Carmel St. Ann's Cancer Center	Westerville	Ohio
United States	Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center	Wilkes-Barre	Pennsylvania
United States	HealthEast Cancer Care at Woodwinds Health Campus	Woodbury	Minnesota
United States	Genesis - Good Samaritan Hospital	Zanesville	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Eastern Cooperative Oncology Group	Cancer and Leukemia Group B, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peri-operative Mortality at 30 Days	The primary endpoint is 30-day peri-operative mortality rate. Proportion of patients died within 30 days of surgery will be reported.	Assessed at 30 days from surgery
Secondary	Rate of Conversion to Open Operation	Proportion of patients who required conversion to operation will be reported.	Assessed at surgery
Secondary	Duration of Operating Time	The length of the operation (total of thoracic and abdominal components) is recorded.	Assessed at surgery
Secondary	Duration of Intensive Care Stay	Number of post-operative days in intensive care is reported.	Assessed after surgery until patients are out of intensive care
Secondary	Overall Length of Hospital Stay	The number of days patients stayed in the hospital after surgery is reported.	Assessed after surgery until patients are out of hospital
Secondary	Total Number of Lymph Nodes Dissected	The total number of lymph nodes dissected is reported to assess the effectiveness of lymph node dissection by MIE.	Assessed at surgery
Secondary	3-year Survival Rate	Patients are followed for survival for 3 years from registration. Overall survival is defined as the time from operation to death.	Assessed at 3 years
Secondary	30-day Peri-operative Mortality After Neoadjuvant Therapy	Proportion of patients with neoadjuvant therapy died within 30 days of operation is reported.	Assessed at 30 days after surgery
Secondary	Rate of Conversion to Open Operation After Neoadjuvant Therapy	Proportion of patients with neoadjuvant therapy required conversion to open operation is reported.	Assessed at surgery