Three Field Radical Esophagectomy Versus Two Field Esophagectomy - a Prospective Trial
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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 |
- Overall survival
- 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 |
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| 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 |
| 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 | |
| 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 May 16, 2013