Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI ECOG-E2202 CALGB-140302, E2202, NCT00063986

Objectives

1. 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.
2. Determine the complications associated with this procedure in these patients.
3. Determine the rate at which conversion to open operation is required in patients undergoing this procedure.
4. Determine the length of the operation, duration of intensive care unit stay, and length of hospital stay in patients undergoing this procedure.
5. Determine feasibility and conversion rate of MIE after neoadjuvant therapy.
6. Assess the effectiveness of lymph node dissection by MIE by recording the total number of lymph nodes dissected.
7. Assess outcomes at follow-up to three years.

Entry Criteria

Disease Characteristics:

• One of the following diagnoses:
  • Histologically confirmed esophageal cancer
    • Stages I-III (T1-3, N0-1)
    • No M1 disease
  • High-grade dysplasia of the esophagus



• Must have a requirement for esophagectomy and be considered an appropriate candidate



• Stomach must be available for conduit (no cancer extending into the stomach more than 20%)

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• No more than 5 months since prior neoadjuvant chemotherapy (patients with esophageal cancer only)

Endocrine therapy

• Not specified

Radiotherapy

• No more than 5 months since prior neoadjuvant radiotherapy (patients with esophageal cancer only)

Surgery

• See Disease Characteristics
• No prior anti-reflux or gastric operations
• No prior right thoracotomy
• No prior major neck operation other than the removal of superficial skin lesion

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Creatinine less than 2 mg/dL

Other

• Prior malignancy allowed

Expected Enrollment

A total of 35-105 patients will be accrued for this study within 9-27 months.

Outcomes

Mortality at 30 days

Morbidity
Rate of conversion to open operation
Effectiveness of lymph node dissection
Duration of operating time
Length of intensive care unit stay and hospital stay
Survival at 3 years
Tumor recurrence
Dysphagia
Home status (i.e., home vs resident in care facility)

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.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

James Luketich, MD, Protocol chair		Ph: 412-647-7555

Cancer and Leukemia Group B

David Sugarbaker, MD, Protocol chair		Ph: 617-732-6824; 800-638-6294

Registry Information
Official Title		Minimally Invasive Esophagectomy (MIE): A Multicenter Feasibility Study
Trial Start Date		2004-03-03
Trial Completion Date		2009-02-28 (estimated)
Registered in ClinicalTrials.gov		NCT00063986
Date Submitted to PDQ		2003-05-14
Information Last Verified		2008-10-22
NCI Grant/Contract Number		CA31946

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