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Three Field Radical Esophagectomy Versus Two Field Esophagectomy - a Prospective Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00193817
Recruitment Status : Unknown
Verified July 2005 by Tata Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : September 19, 2005
Last Update Posted : February 7, 2006
Information provided by:
Tata Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Cancer of Esophagus Procedure: Two field vs Three field lymphadenectomy Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2005
Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Overall survival

Secondary Outcome Measures :
  1. Disease-free survival
  2. Quality of Life

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with biopsy or cytology proven (squamous or adenocarcinoma) esophageal cancer
  • Patients with staging investigations showing operability
  • Surgical plan of total transthoracic esophagectomy

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00193817

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Contact: Rajesh C Mistry, MS 91-22-2417 7000 ext 7277
Contact: C S Pramesh, MS 91-22-2417000 ext 7070

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Tata Memorial Hospital Recruiting
Mumbai, Maharashtra, India, 400012
Contact: Rajesh C Mistry, MS    91 22 24177000 ext 7277   
Contact: C S Pramesh, MS    91 22 24177000 ext 7070   
Principal Investigator: Rajesh C Mistry, MS         
Sub-Investigator: C S Pramesh, MS, FRCS         
Sponsors and Collaborators
Tata Memorial Hospital
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Principal Investigator: Rajesh C Mistry, MS Tata Memorial Hospital
Principal Investigator: C S Pramesh, MS, FRCS Tata Memorial Hospital

Layout table for additonal information Identifier: NCT00193817    
Other Study ID Numbers: TMH 111/IM-2004
DAECTC/Projno 5 / 2004-05
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: February 7, 2006
Last Verified: July 2005
Keywords provided by Tata Memorial Hospital:
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases