Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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.

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

Eligibility 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%)

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

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Eastern Cooperative Oncology Group

James D. Luketich

Study Chair

David J. Sugarbaker

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00063986
Information obtained from ClinicalTrials.gov on December 14, 2011

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