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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00063986 |
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Date of registration:
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08/07/2003 |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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Minimally Invasive Esophagectomy (MIE): A Multicenter Feasibility Study |
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Date of first enrolment:
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March 2004 |
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Target sample size:
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105 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00063986 |
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Study type:
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Interventional |
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Study design:
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Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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David J. Sugarbaker, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Dana-Farber/Brigham and Women's Cancer Center |
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Name:
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James D. Luketich, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Pittsburgh |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Esophageal Cancer
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Intervention(s)
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Procedure: laparoscopic surgery
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Procedure: thoracoscopic surgery
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Primary Outcome(s)
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Mortality at 30 days
[Time Frame: No]
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Secondary Outcome(s)
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Duration of operating time
[Time Frame: No]
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Dysphagia
[Time Frame: No]
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Effectiveness of lymph node dissection
[Time Frame: No]
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Home status (i.e., home vs resident in care facility)
[Time Frame: No]
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Length of intensive care unit stay and hospital stay
[Time Frame: No]
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Morbidity
[Time Frame: No]
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Rate of conversion to open operation
[Time Frame: No]
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Survival at 3 years
[Time Frame: No]
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Tumor recurrence
[Time Frame: No]
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Secondary ID(s)
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CALGB-140302
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CDR0000305866
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ECOG-E2202
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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