search
Back to results

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

Primary Purpose

Esophageal Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Minimally invasive esophagectomy (MIE)
Sponsored by
Eastern Cooperative Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring esophageal cancer, minimally invasive esophagectomy (MIE)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
  • Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
  • University of Chicago Cancer Research Center
  • Boston University Cancer Research Center
  • Hutchinson Area Health Care
  • Meeker County Memorial Hospital
  • HealthEast Cancer Care at St. John's Hospital
  • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
  • Hennepin County Medical Center - Minneapolis
  • Masonic Cancer Center at University of Minnesota
  • Regions Hospital Cancer Care Center
  • HealthEast Cancer Care at St. Joseph's Hospital
  • St. Francis Cancer Center at St. Francis Medical Center
  • HealthEast Cancer Care at Woodwinds Health Campus
  • CCOP - Missouri Valley Cancer Consortium
  • Immanuel Medical Center
  • Alegant Health Cancer Center at Bergan Mercy Medical Center
  • Creighton University Medical Center
  • Mount Sinai Medical Center
  • Mary Rutan Hospital
  • Adena Regional Medical Center
  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
  • Riverside Methodist Hospital Cancer Care
  • CCOP - Columbus
  • Grant Medical Center Cancer Care
  • Mount Carmel Health - West Hospital
  • Doctors Hospital at Ohio Health
  • Grady Memorial Hospital
  • Fairfield Medical Center
  • Strecker Cancer Center at Marietta Memorial Hospital
  • Licking Memorial Cancer Care Program at Licking Memorial Hospital
  • Mercy Medical Center
  • Community Hospital of Springfield and Clark County
  • Mount Carmel St. Ann's Cancer Center
  • Genesis - Good Samaritan Hospital
  • Geisinger Cancer Institute at Geisinger Health
  • UPMC Cancer Centers
  • Geisinger Medical Group - Scenery Park
  • Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
  • Medical City Dallas Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Minimally invasive esophagectomy (MIE)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Rate of Conversion to Open Operation
Proportion of patients who required conversion to operation will be reported.
Duration of Operating Time
The length of the operation (total of thoracic and abdominal components) is recorded.
Duration of Intensive Care Stay
Number of post-operative days in intensive care is reported.
Overall Length of Hospital Stay
The number of days patients stayed in the hospital after surgery is reported.
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.
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.
30-day Peri-operative Mortality After Neoadjuvant Therapy
Proportion of patients with neoadjuvant therapy died within 30 days of operation is reported.
Rate of Conversion to Open Operation After Neoadjuvant Therapy
Proportion of patients with neoadjuvant therapy required conversion to open operation is reported.

Full Information

First Posted
July 8, 2003
Last Updated
June 14, 2023
Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI), Cancer and Leukemia Group B
search

1. Study Identification

Unique Protocol Identification Number
NCT00063986
Brief Title
Esophagectomy in Treating Patients With High-Grade Dysplasia of the Esophagus or Stage I, Stage II, or Stage III Esophageal Cancer
Official Title
Minimally Invasive Esophagectomy (MIE): A Multicenter Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
June 24, 2004 (Actual)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI), Cancer and Leukemia Group B

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
esophageal cancer, minimally invasive esophagectomy (MIE)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James D. Luketich, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Study Chair
Facility Information:
Facility Name
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31403-3089
Country
United States
Facility Name
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-3013
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Boston University Cancer Research Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Hutchinson Area Health Care
City
Hutchinson
State/Province
Minnesota
ZIP/Postal Code
55350
Country
United States
Facility Name
Meeker County Memorial Hospital
City
Litchfield
State/Province
Minnesota
ZIP/Postal Code
55355
Country
United States
Facility Name
HealthEast Cancer Care at St. John's Hospital
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55109
Country
United States
Facility Name
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Hennepin County Medical Center - Minneapolis
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
Masonic Cancer Center at University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Regions Hospital Cancer Care Center
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
HealthEast Cancer Care at St. Joseph's Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
St. Francis Cancer Center at St. Francis Medical Center
City
Shakopee
State/Province
Minnesota
ZIP/Postal Code
55379
Country
United States
Facility Name
HealthEast Cancer Care at Woodwinds Health Campus
City
Woodbury
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
Facility Name
CCOP - Missouri Valley Cancer Consortium
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68106
Country
United States
Facility Name
Immanuel Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68122
Country
United States
Facility Name
Alegant Health Cancer Center at Bergan Mercy Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Facility Name
Creighton University Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131-2197
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Mary Rutan Hospital
City
Bellefontaine
State/Province
Ohio
ZIP/Postal Code
43311
Country
United States
Facility Name
Adena Regional Medical Center
City
Chillicothe
State/Province
Ohio
ZIP/Postal Code
45601
Country
United States
Facility Name
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States
Facility Name
Riverside Methodist Hospital Cancer Care
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214-3998
Country
United States
Facility Name
CCOP - Columbus
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Grant Medical Center Cancer Care
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Mount Carmel Health - West Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43222
Country
United States
Facility Name
Doctors Hospital at Ohio Health
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43228
Country
United States
Facility Name
Grady Memorial Hospital
City
Delaware
State/Province
Ohio
ZIP/Postal Code
43015
Country
United States
Facility Name
Fairfield Medical Center
City
Lancaster
State/Province
Ohio
ZIP/Postal Code
43130
Country
United States
Facility Name
Strecker Cancer Center at Marietta Memorial Hospital
City
Marietta
State/Province
Ohio
ZIP/Postal Code
45750
Country
United States
Facility Name
Licking Memorial Cancer Care Program at Licking Memorial Hospital
City
Newark
State/Province
Ohio
ZIP/Postal Code
43055
Country
United States
Facility Name
Mercy Medical Center
City
Springfield
State/Province
Ohio
ZIP/Postal Code
45504
Country
United States
Facility Name
Community Hospital of Springfield and Clark County
City
Springfield
State/Province
Ohio
ZIP/Postal Code
45505
Country
United States
Facility Name
Mount Carmel St. Ann's Cancer Center
City
Westerville
State/Province
Ohio
ZIP/Postal Code
43081
Country
United States
Facility Name
Genesis - Good Samaritan Hospital
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
Country
United States
Facility Name
Geisinger Cancer Institute at Geisinger Health
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822-0001
Country
United States
Facility Name
UPMC Cancer Centers
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Geisinger Medical Group - Scenery Park
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States
Facility Name
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18711
Country
United States
Facility Name
Medical City Dallas Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs