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

Completed · Phase 2

Conditions studied: Esophageal Cancer

In brief

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.

Key facts

Study ID

NCT00063986

Run by

Eastern Cooperative Oncology Group

People needed

110

Starts

2004-06-24

Expected to finish

2012-08-01

Last updated by the study team

2023-06-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.)

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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