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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2005 by Tata Memorial Hospital
Sponsor:
Information provided by:
Tata Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00193817
First received: September 14, 2005
Last updated: February 6, 2006
Last verified: July 2005
  Purpose

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 Intervention Phase
Cancer of Esophagus
Procedure: Two field vs Three field lymphadenectomy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Tata Memorial Hospital:

Primary Outcome Measures:
  • Overall survival

Secondary Outcome Measures:
  • Disease-free survival
  • Quality of Life

Estimated Enrollment: 700
Study Start Date: January 2005
Estimated Study Completion Date: December 2015
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00193817     History of Changes
Other Study ID Numbers: TMH 111/IM-2004, DAECTC/Projno 5 / 2004-05
Study First Received: September 14, 2005
Last Updated: February 6, 2006
Health Authority: India: Department of Atomic Energy

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

ClinicalTrials.gov processed this record on September 18, 2014