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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00063986

  Show 41 Study Locations
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 Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 21, 2014