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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by All India Institute of Medical Sciences, New Delhi.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT01151839
First received: June 25, 2010
Last updated: July 8, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention
Esophageal Neoplasms
Procedure: Esophagectomy
Procedure: Neoadjuvant chemoradiation followed by surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Preoperative Chemoradiation and Surgery Versus Surgery Alone in Squamous Cell Carcinoma of Oesophagus - A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:
  • Resectability rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To compare the resectability rate of carcinoma esophagus between patients randomized to surgery alone and neoadjuvant chemoradiation followed by surgery

  • postoperative morbidity [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    To compare the postoperative morbidity between patients of carcinoma esophagus randomized to surgery alone versus chemoradiation followed by surgery

  • operative mortality [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    To compare the operative mortality between patients randomized to surgery alone and neoadjuvant chemoradiation followed by surgery.


Secondary Outcome Measures:
  • Early disease control [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To compare the early disease control in patients randomized to receive either neoadjuvant chemoradiation and surgery or surgery alone.

  • Treatment toxicity [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    This study will also assess the treatment toxicity of preoperative chemoradiation


Estimated Enrollment: 100
Study Start Date: June 2010
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01151839

Contacts
Contact: Nikhil -, MS 91-9654055630 drnkhl@gmail.com

Locations
India
All India Institute of Medical Sciences Recruiting
New Delhi, Delhi, India, 110029
Contact: Nikhil , MS    91-9654055630    drnkhl@gmail.com   
Principal Investigator: Nikhil -, MS         
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Investigators
Principal Investigator: Nikhil -, MS All India Institute of Medical Sciences, New Delhi
  More Information

No publications provided

Responsible Party: Dr. Nikhil, AIIMS
ClinicalTrials.gov Identifier: NCT01151839     History of Changes
Other Study ID Numbers: IESC/T-186/2010
Study First Received: June 25, 2010
Last Updated: July 8, 2010
Health Authority: India: Institutional Review Board

Keywords provided by All India Institute of Medical Sciences, New Delhi:
Esophagus
squamous cell carcinoma
neoadjuvant chemoradiation

Additional relevant MeSH terms:
Esophageal Neoplasms
Neoplasms
Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on August 27, 2014