Esophagectomy in Treating Patients With High-Grade Dysplasia of the Esophagus or Stage I, Stage II, or Stage III Esophageal Cancer
NCT ID: NCT00063986
Last Updated: 2023-06-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
110 participants
INTERVENTIONAL
2004-06-24
2012-08-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Prior anti-reflux or gastric operations
* Prior right thoracotomy
* Prior major neck operation other than the removal of superficial skin lesion
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Cancer and Leukemia Group B
NETWORK
Eastern Cooperative Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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James D. Luketich, MD
Role: STUDY_CHAIR
University of Pittsburgh
Locations
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Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange, California, United States
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, 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
Boston University Cancer Research Center
Boston, Massachusetts, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, United States
Meeker County Memorial Hospital
Litchfield, Minnesota, United States
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, United States
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, United States
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States
Regions Hospital Cancer Care Center
Saint Paul, Minnesota, United States
HealthEast Cancer Care at St. Joseph's Hospital
Saint Paul, Minnesota, United States
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota, United States
HealthEast Cancer Care at Woodwinds Health Campus
Woodbury, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States
Immanuel Medical Center
Omaha, Nebraska, United States
Alegant Health Cancer Center at Bergan Mercy Medical Center
Omaha, Nebraska, United States
Creighton University Medical Center
Omaha, Nebraska, United States
Mount Sinai Medical Center
New York, New York, United States
Mary Rutan Hospital
Bellefontaine, Ohio, 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
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States
CCOP - Columbus
Columbus, Ohio, United States
Grant Medical Center Cancer Care
Columbus, Ohio, United States
Mount Carmel Health - West Hospital
Columbus, Ohio, United States
Doctors Hospital at Ohio Health
Columbus, Ohio, United States
Grady Memorial Hospital
Delaware, Ohio, United States
Fairfield Medical Center
Lancaster, Ohio, United States
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, United States
Mercy Medical Center
Springfield, Ohio, United States
Community Hospital of Springfield and Clark County
Springfield, Ohio, United States
Mount Carmel St. Ann's Cancer Center
Westerville, Ohio, United States
Genesis - Good Samaritan Hospital
Zanesville, Ohio, United States
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, United States
UPMC Cancer Centers
Pittsburgh, Pennsylvania, United States
Geisinger Medical Group - Scenery Park
State College, Pennsylvania, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States
Medical City Dallas Hospital
Dallas, Texas, United States
Countries
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Other Identifiers
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E2202
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000305866
Identifier Type: -
Identifier Source: org_study_id
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