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Phase II Study of Minimally Invasive Esophagectomy in Patients With High-Grade Dysplasia of the Esophagus or Stage I-III Esophageal Cancer
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 | Protocol IDs |
|---|
| Phase II | Treatment | Closed | 18 and over | ECOG-E2202
CALGB-140302, E2202, NCT00063986 |
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.
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 Chemotherapy - No more than 5 months since prior neoadjuvant chemotherapy (patients with esophageal cancer only)
Endocrine therapy 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 Performance status Life expectancy Hematopoietic Hepatic Renal - Creatinine less than 2 mg/dL
Other Expected Enrollment 105A total of 35-105 patients will be accrued for this study within 9-27 months. Outcomes Primary Outcome(s)Mortality at 30 days
Secondary Outcome(s)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 | | | |
Cancer and Leukemia Group B | | | | David Sugarbaker, MD, Protocol chair | | | Ph: 617-732-6824; 800-638-6294 |
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| 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 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.  Back to Top |
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