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

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ClinicalTrials.gov 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
Sponsor:
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

  Show Detailed Description

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

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U.S. FDA Resources




Primary Outcome Measures :
  1. Overall survival

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


Information from the National Library of Medicine

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

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 ClinicalTrials.gov identifier (NCT number): NCT00193817


Contacts
Contact: Rajesh C Mistry, MS 91-22-2417 7000 ext 7277 mistryrc@tmcmail.org
Contact: C S Pramesh, MS 91-22-2417000 ext 7070 cspramesh@vsnl.net

Locations
India
Tata Memorial Hospital Recruiting
Mumbai, Maharashtra, India, 400012
Contact: Rajesh C Mistry, MS    91 22 24177000 ext 7277    mistryrc@tmcmail.org   
Contact: C S Pramesh, MS    91 22 24177000 ext 7070    cspramesh@vsnl.net   
Principal Investigator: Rajesh C Mistry, MS         
Sub-Investigator: C S Pramesh, MS, FRCS         
Sponsors and Collaborators
Tata Memorial Hospital
Investigators
Principal Investigator: Rajesh C Mistry, MS Tata Memorial Hospital
Principal Investigator: C S Pramesh, MS, FRCS Tata Memorial Hospital

ClinicalTrials.gov Identifier: NCT00193817     History of Changes
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:
Cancer
Esophagus
Lymphadenectomy

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases