Three Field Radical Esophagectomy Versus Two Field Esophagectomy - a Prospective Trial
2 other identifiers
interventional
700
1 country
1
Brief Summary
Surgery is the standard treatment for esophageal (food pipe) cancer. Esophageal cancer is known to spread to the lymph nodes (glands) adjacent to the esophagus. The extent of lymph nodes that need to be removed along with removal of the esophagus is a controversial topic. The basic surgery will remain the same i.e., the foodpipe in the chest will be removed and a new substitute will be created from the stomach and joined to the foodpipe in the neck. This will involve incisions in the chest, abdomen and neck. We intend to compare two types of lymphadenectomy (removal of lymph nodes) - the two field lymphadenectomy, whereby the lymph nodes in the abdomen and the lower half of the chest will be removed and three field lymphadenectomy, wherein lymph nodes in the abdomen, the whole chest and the lower neck will be removed. Both these procedures are practised widely worldwide and there is no definite scientific evidence showing the superiority of either of them. We are conducting this study to see whether one of these procedures is superior to the other. Seven hundred patients are expected to participate in this study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2005
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 14, 2005
CompletedFirst Posted
Study publicly available on registry
September 19, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFebruary 7, 2006
July 1, 2005
September 14, 2005
February 6, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
Secondary Outcomes (2)
Disease-free survival
Quality of Life
Interventions
Eligibility Criteria
You may qualify if:
- Patients with biopsy or cytology proven (squamous or adenocarcinoma) esophageal cancer
- Patients with staging investigations showing operability
- Surgical plan of total transthoracic esophagectomy
You may not qualify if:
- Patients with low performance status (ECOG score\>1)
- Past history of malignancy
- Staging investigations indicating advanced disease
- Patients medically unfit for surgical resection
- Patients with pulmonary reserve inadequate to undergo thoracotomy and extensive mediastinal lymphadenectomy
- Patients considered for salvage surgery after definitive (radical)chemoradiotherapy
- Patients with supracarinal lymph node enlargement on CT scan and/or EUS
- Patients intraoperatively detected to have grossly enlarged supracarinal lymph nodes
- Patients with Siewert's type III CO junction growths
- Patients above the age of 70 years
- Patients unreliable for follow up
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tata Memorial Hospital
Mumbai, Maharashtra, 400012, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rajesh C Mistry, MS
Tata Memorial Hospital
- PRINCIPAL INVESTIGATOR
C S Pramesh, MS, FRCS
Tata Memorial Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
September 14, 2005
First Posted
September 19, 2005
Study Start
January 1, 2005
Study Completion
December 1, 2015
Last Updated
February 7, 2006
Record last verified: 2005-07