A Trial to Compare Preoperative Chemoradiation and Surgery Versus Surgery Alone in Squamous Cell Carcinoma of Oesophagus

July 8, 2010 updated by: All India Institute of Medical Sciences, New Delhi

Preoperative Chemoradiation and Surgery Versus Surgery Alone in Squamous Cell Carcinoma of Oesophagus - A Randomized Controlled Trial

Carcinoma of the esophagus is the among the most common cancers in Indian population. While adenocarcinoma is more common in western countries, in India squamous cell carcinoma is the more frequent form. Surgery is the standard treatment in resectable lesions, but survival is poor. Adjuvant and neoadjuvant treatment therapy is used with an aim to improve the results. Though few randomized trials have addressed the issue of neoadjuvant chemoradiotherapy, the methodology was inhomogeneous and the populations studied were different. The investigators will be conducting a randomized controlled trial in patients with squamous cell carcinoma of the esophagus. Preoperative chemoradiation followed by surgery will be compared with surgery alone.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • India
    • Delhi
      • New Delhi, Delhi, India, 110029
        • Recruiting
        • All India Institute of Medical Sciences
        • Contact:
        • Principal Investigator:
          • Nikhil -, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age < 65 years
  2. Squamous cell carcinoma
  3. Good performance status (Eastern Cooperative Oncology Group [ECOG] grades 0, 1 and 2)
  4. Contrast enhanced computerized tomographic (CECT) scan suggesting a potentially resectable lesion. The features of resectability assessed on CECT scan will include - no evidence of infiltration of mediastinal structures such as the aorta (angle of contact <900, no obliteration of the triangular fat space between the esophagus, aorta, and spine), and pericardium20, and no evidence of tracheobronchial fistula or tumor extension into the airway lumen.
  5. No evidence of distant metastasis on CECT.

Exclusion Criteria:

  1. Patient refused consent for the study

  2. Comorbid conditions which would preclude oesophagectomy

    • Poor performance status (ECOG > 2)
    • American Society of Anesthesiologists class IV
  3. Metastatic disease detected on evaluation
  4. Involvement of mediastinal structures except
  5. Carcinoma involving cervical esophagus
  6. Previous radiotherapy or chemotherapy

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Surgery Alone
Procedure: Esophagectomy
Patient with squamous cell carcinoma of esophagus will be treated with surgery alone
Active Comparator: Neoadjuvant chemoradiation followed by surgery
Procedure: Neoadjuvant chemoradiation followed by surgery
Patient with squamous cell carcinoma of esophagus will be treated by neoadjuvant chemoradiation followed by surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resectability rate
Time Frame: 2 years
To compare the resectability rate of carcinoma esophagus between patients randomized to surgery alone and neoadjuvant chemoradiation followed by surgery
2 years
postoperative morbidity
Time Frame: 2 Years
To compare the postoperative morbidity between patients of carcinoma esophagus randomized to surgery alone versus chemoradiation followed by surgery
2 Years
operative mortality
Time Frame: 2 Years
To compare the operative mortality between patients randomized to surgery alone and neoadjuvant chemoradiation followed by surgery.
2 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early disease control
Time Frame: 2 years
To compare the early disease control in patients randomized to receive either neoadjuvant chemoradiation and surgery or surgery alone.
2 years
Treatment toxicity
Time Frame: 2 years
This study will also assess the treatment toxicity of preoperative chemoradiation
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

All India Institute of Medical Sciences, New Delhi

Investigators

  • Principal Investigator: Nikhil -, MS, All India Institute of Medical Sciences, New Delhi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Anticipated)

July 1, 2012

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

June 25, 2010

First Submitted That Met QC Criteria

June 28, 2010

First Posted (Estimate)

June 29, 2010

Study Record Updates

Last Update Posted (Estimate)

July 12, 2010

Last Update Submitted That Met QC Criteria

July 8, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IESC/T-186/2010

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Esophageal Neoplasms

Clinical Trials on Esophagectomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe