Esophageal Cancer Clinical Trial

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

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.

View Full Description

Full 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.

View Eligibility Criteria

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

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Estimated Enrollment:

110

Study ID:

NCT00063986

Recruitment Status:

Completed

Sponsor:

Eastern Cooperative Oncology Group

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 40 Locations for this study

See Locations Near You

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

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Estimated Enrollment:

110

Study ID:

NCT00063986

Recruitment Status:

Completed

Sponsor:


Eastern Cooperative Oncology Group

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.