Suspended

Comparison of Three Field and Two Field Esophagectomy for Esophageal Cancer

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What is being tested

Data Collection

Who is being recruted

Digestive System Diseases+6

+ Digestive System Neoplasms

+ Esophageal Diseases

From 18 to 70 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: January 2005
See protocol details

Summary

Principal SponsorTata Memorial Hospital
Study ContactRajesh C Mistry, MSMore contacts
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2005

Actual date on which the first participant was enrolled.

Esophageal cancer is a common health issue worldwide, often associated with a poor outlook. Surgery is the main treatment, offering the best chance for a cure and long-term survival. However, results have been disappointing despite improvements in postoperative care and surgical techniques. This study aims to compare two surgical approaches: three-field and two-field esophagectomy, focusing on the efficacy of radical lymph node dissection in improving survival and quality of life. This research is important because there's currently no clear evidence on whether three-field lymphadenectomy, a more extensive procedure, significantly improves survival over two-field lymphadenectomy. The study will include patients with biopsy-proven esophageal cancer who are deemed operable and fit for major surgery. In this prospective randomized controlled trial, participants will undergo standard staging investigations, including CT scans and endoscopic ultrasounds. They will then be randomized into two groups, undergoing either three-field or two-field esophagectomy. The study will compare overall survival, disease-free survival, and postoperative complications between the two groups. It will also evaluate short and long-term quality of life after the procedures. All surgeries will be performed under general anesthesia, either by or under the direct supervision of experienced thoracic surgeons.

Official TitleThree Field Radical Esophagectomy Versus Two Field Esophagectomy - a Prospective Trial
NCT00193817
Principal SponsorTata Memorial Hospital
Study ContactRajesh C Mistry, MSMore contacts
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

700 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesDigestive System NeoplasmsEsophageal DiseasesEsophageal NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsHead and Neck NeoplasmsNeoplasmsNeoplasms by Site

Criteria

3 inclusion criteria required to participate
Surgical plan of total transthoracic esophagectomy

Patients with staging investigations showing operability

Patients with biopsy or cytology proven (squamous or adenocarcinoma) esophageal cancer

11 exclusion criteria prevent from participating
Patients with low performance status (ECOG score>1)

Patients with pulmonary reserve inadequate to undergo thoracotomy and extensive mediastinal lymphadenectomy

Patients medically unfit for surgical resection

Staging investigations indicating advanced disease

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Tata Memorial Hospital

Mumbai, IndiaOpen Tata Memorial Hospital in Google Maps
SuspendedOne Study Center