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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:
National Cancer Institute (NCI)
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
History of Changes
  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:

U.S. FDA Resources

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

  Show 41 Study Locations
Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Cancer and Leukemia Group B
Investigators
Study Chair: James D. Luketich, MD University of Pittsburgh
  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: 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 Diseases
Esophageal Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
 Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on May 16, 2013