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

Sponsor:	Eastern Cooperative Oncology Group
Collaborators:	National Cancer Institute (NCI) Cancer and Leukemia Group B
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00063986

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: laparoscopic surgery Procedure: thoracoscopic surgery	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Minimally Invasive Esophagectomy (MIE): A Multicenter Feasibility Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders Surgery

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Mortality at 30 days [ Designated as safety issue: No ]

Secondary Outcome Measures:

Morbidity [ Designated as safety issue: No ]
Rate of conversion to open operation [ Designated as safety issue: No ]
Effectiveness of lymph node dissection [ Designated as safety issue: No ]
Duration of operating time [ Designated as safety issue: No ]
Length of intensive care unit stay and hospital stay [ Designated as safety issue: No ]
Survival at 3 years [ Designated as safety issue: No ]
Tumor recurrence [ Designated as safety issue: No ]
Dysphagia [ Designated as safety issue: No ]
Home status (i.e., home vs resident in care facility) [ Designated as safety issue: No ]

Estimated Enrollment:	105
Study Start Date:	March 2004
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

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.

PROJECTED ACCRUAL: A total of 35-105 patients will be accrued for this study within 9-27 months.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

One of the following diagnoses:
- Histologically confirmed esophageal cancer
  - Stages I-III (T1-3, N0-1)
  - No M1 disease
- High-grade dysplasia of the esophagus
Must have a requirement for esophagectomy and be considered an appropriate candidate
Stomach must be available for conduit (no cancer extending into the stomach more than 20%)

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-2

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Creatinine less than 2 mg/dL

Other

Prior malignancy allowed

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

No more than 5 months since prior neoadjuvant chemotherapy (patients with esophageal cancer only)

Endocrine therapy

Not specified

Radiotherapy

No more than 5 months since prior neoadjuvant radiotherapy (patients with esophageal cancer only)

Surgery

See Disease Characteristics
No prior anti-reflux or gastric operations
No prior right thoracotomy
No 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

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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
HealthEast Cancer Care at St. Joseph's Hospital
Saint Paul, Minnesota, United States, 55102
HealthEast Cancer Care at Woodwinds Health Campus
Woodbury, Minnesota, United States, 55125
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55415
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, United States, 55109
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States, 55455
Meeker County Memorial Hospital
Lichfield, Minnesota, United States, 55355
Regions Hospital Cancer Care Center
St. Paul, Minnesota, United States, 55101
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota, United States, 55379
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
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
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210-1240
CCOP - Columbus
Columbus, Ohio, United States, 43215
Community Hospital of Springfield and Clark County
Springfield, Ohio, United States, 45505
Doctors Hospital at Ohio Health
Columbus, Ohio, United States, 43228
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
Mary Rutan Hospital
Bellefontaine, Ohio, United States, 43311
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Grant Medical Center Cancer Care
Columbus, Ohio, United States, 43215
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, United States, 43055
Genesis - Good Samaritan Hospital
Zanesville, Ohio, United States, 43701
Mercy Medical Center
Springfield, Ohio, United States, 45504
Mount Carmel Health - West Hospital
Columbus, Ohio, United States, 43222
Mount Carmel St. Ann's Cancer Center
Westerville, Ohio, United States, 43081
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States, 43214-3998
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
United States, Pennsylvania
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States, 18711
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, United States, 17822-0001
Geisinger Medical Group - Scenery Park
State College, Pennsylvania, United States, 16801
UPMC Cancer Centers
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
Medical City Dallas Hospital
Dallas, Texas, United States, 75230

Sponsors and Collaborators

Eastern Cooperative Oncology Group

National Cancer Institute (NCI)

Cancer and Leukemia Group B

Investigators

Study Chair:	James D. Luketich, MD	UPMC Cancer Centers
Study Chair:	David J. Sugarbaker, MD	Dana-Farber/Brigham and Women's Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	ECOG Group Chair's Office ( Robert L. Comis )
Study ID Numbers:	CDR0000305866, ECOG-E2202, CALGB-140302
Study First Received:	July 8, 2003
Last Updated:	April 14, 2009
ClinicalTrials.gov Identifier:	NCT00063986 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I esophageal cancer
stage II esophageal cancer
stage III esophageal cancer

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases

Head and Neck Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Esophageal Diseases

ClinicalTrials.gov processed this record on November 25, 2009