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

This study has been completed.
Sponsor:
Collaborators:
Cancer and Leukemia Group B
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00063986
First received: July 8, 2003
Last updated: February 7, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Esophageal Cancer
Procedure: Minimally invasive esophagectomy (MIE)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Minimally Invasive Esophagectomy (MIE): A Multicenter Feasibility Study

Resource links provided by NLM:


Further study details as provided by Eastern Cooperative Oncology Group:

Primary Outcome Measures:
  • Peri-operative Mortality at 30 Days [ Time Frame: Assessed at 30 days from surgery ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Assessed at surgery ] [ Designated as safety issue: No ]
    Proportion of patients who required conversion to operation will be reported.

  • Duration of Operating Time [ Time Frame: Assessed at surgery ] [ Designated as safety issue: No ]
    The length of the operation (total of thoracic and abdominal components) is recorded.

  • Duration of Intensive Care Stay [ Time Frame: Assessed after surgery until patients are out of intensive care ] [ Designated as safety issue: No ]
    Number of post-operative days in intensive care is reported.

  • Overall Length of Hospital Stay [ Time Frame: Assessed after surgery until patients are out of hospital ] [ Designated as safety issue: No ]
    The number of days patients stayed in the hospital after surgery is reported.

  • Total Number of Lymph Nodes Dissected [ Time Frame: Assessed at surgery ] [ Designated as safety issue: No ]
    The total number of lymph nodes dissected is reported to assess the effectiveness of lymph node dissection by MIE.

  • 3-year Survival Rate [ Time Frame: Assessed at 3 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: Assessed at 30 days after surgery ] [ Designated as safety issue: Yes ]
    Proportion of patients with neoadjuvant therapy died within 30 days of operation is reported.

  • Rate of Conversion to Open Operation After Neoadjuvant Therapy [ Time Frame: Assessed at surgery ] [ Designated as safety issue: No ]
    Proportion of patients with neoadjuvant therapy required conversion to open operation is reported.


Enrollment: 110
Study Start Date: March 2004
Study Completion Date: August 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00063986

  Hide Study Locations
Locations
United States, California
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange, California, United States, 92868
United States, Georgia
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States, 31403-3089
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Massachusetts
Boston University Cancer Research Center
Boston, Massachusetts, United States, 02118
United States, Minnesota
Hutchinson Area Health Care
Hutchinson, Minnesota, United States, 55350
Meeker County Memorial Hospital
Lichfield, Minnesota, United States, 55355
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, United States, 55109
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55415
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States, 55455
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
HealthEast Cancer Care at St. Joseph's Hospital
Saint Paul, Minnesota, United States, 55102
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota, United States, 55379
Regions Hospital Cancer Care Center
St. Paul, Minnesota, United States, 55101
HealthEast Cancer Care at Woodwinds Health Campus
Woodbury, Minnesota, United States, 55125
United States, Nebraska
Alegant Health Cancer Center at Bergan Mercy Medical Center
Omaha, Nebraska, United States, 68124
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
Creighton University Medical Center
Omaha, Nebraska, United States, 68131-2197
Immanuel Medical Center
Omaha, Nebraska, United States, 68122
United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029
United States, Ohio
Mary Rutan Hospital
Bellefontaine, Ohio, United States, 43311
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
CCOP - Columbus
Columbus, Ohio, United States, 43215
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210-1240
Doctors Hospital at Ohio Health
Columbus, Ohio, United States, 43228
Mount Carmel Health - West Hospital
Columbus, Ohio, United States, 43222
Grant Medical Center Cancer Care
Columbus, Ohio, United States, 43215
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States, 43214-3998
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, United States, 43055
Community Hospital of Springfield and Clark County
Springfield, Ohio, United States, 45505
Mercy Medical Center
Springfield, Ohio, United States, 45504
Mount Carmel St. Ann's Cancer Center
Westerville, Ohio, United States, 43081
Genesis - Good Samaritan Hospital
Zanesville, Ohio, United States, 43701
United States, Pennsylvania
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, United States, 17822-0001
UPMC Cancer Centers
Pittsburgh, Pennsylvania, United States, 15232
Geisinger Medical Group - Scenery Park
State College, Pennsylvania, United States, 16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States, 18711
United States, Texas
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Cancer and Leukemia Group B
Investigators
Study Chair: James D. Luketich, MD University of Pittsburgh
  More Information

Additional Information:
No publications provided

Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00063986     History of Changes
Other Study ID Numbers: CDR0000305866, U10CA021115, E2202
Study First Received: July 8, 2003
Results First Received: November 29, 2012
Last Updated: February 7, 2013
Health Authority: United States: Federal Government

Keywords provided by Eastern Cooperative Oncology Group:
esophageal cancer
minimally invasive esophagectomy (MIE)

Additional relevant MeSH terms:
Esophageal Diseases
Esophageal Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on May 22, 2013