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

Tracking Information

First Received Date ^ICMJE

July 8, 2003

Last Updated Date

April 14, 2009

Start Date ^ICMJE

March 2004

Estimated Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Mortality at 30 days [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Mortality at 30 days

Change History

Complete list of historical versions of study NCT00063986 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Morbidity [ Designated as safety issue: No ]
Rate of conversion to open operation [ Designated as safety issue: No ]
Effectiveness of lymph node dissection [ Designated as safety issue: No ]
Duration of operating time [ Designated as safety issue: No ]
Length of intensive care unit stay and hospital stay [ Designated as safety issue: No ]
Survival at 3 years [ Designated as safety issue: No ]
Tumor recurrence [ Designated as safety issue: No ]
Dysphagia [ Designated as safety issue: No ]
Home status (i.e., home vs resident in care facility) [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

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)

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Minimally Invasive Esophagectomy (MIE): A Multicenter Feasibility Study

Brief 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.

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.

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

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label

Condition ^ICMJE

Esophageal Cancer

Intervention ^ICMJE

Procedure: laparoscopic surgery
Procedure: thoracoscopic surgery

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

105

Completion Date

Estimated Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00063986

Responsible Party

Robert L. Comis, ECOG Group Chair's Office

Study ID Numbers ^ICMJE

CDR0000305866, ECOG-E2202, CALGB-140302

Study Sponsor ^ICMJE

Eastern Cooperative Oncology Group

Collaborators ^ICMJE

National Cancer Institute (NCI)
Cancer and Leukemia Group B

Investigators ^ICMJE

Study Chair:	James D. Luketich, MD	UPMC Cancer Centers
Study Chair:	David J. Sugarbaker, MD	Dana-Farber/Brigham and Women's Cancer Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP