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

NCT01151839 | Unknown

• 1 other identifier: IESC/T-186/2010
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Esophageal Neoplasms

Keywords

Esophagus; squamous cell carcinoma; neoadjuvant chemoradiation

Outcome Measures

Primary Outcomes (3)

• Resectability rate

  To compare the resectability rate of carcinoma esophagus between patients randomized to surgery alone and neoadjuvant chemoradiation followed by surgery

  2 years

• postoperative morbidity

  To compare the postoperative morbidity between patients of carcinoma esophagus randomized to surgery alone versus chemoradiation followed by surgery

  2 Years

• operative mortality

  To compare the operative mortality between patients randomized to surgery alone and neoadjuvant chemoradiation followed by surgery.

  2 Years

Secondary Outcomes (2)

• Early disease control

  2 years

• Treatment toxicity

  2 years

Study Arms (2)

Surgery Alone

ACTIVE COMPARATOR

Procedure: Esophagectomy

Neoadjuvant chemoradiation followed by surgery

ACTIVE COMPARATOR

Procedure: Neoadjuvant chemoradiation followed by surgery

Interventions

Esophagectomy PROCEDURE

Patient with squamous cell carcinoma of esophagus will be treated with surgery alone

Surgery Alone

Neoadjuvant chemoradiation followed by surgery PROCEDURE

Patient with squamous cell carcinoma of esophagus will be treated by neoadjuvant chemoradiation followed by surgery

Neoadjuvant chemoradiation followed by surgery

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \< 65 years
• Squamous cell carcinoma
• Good performance status (Eastern Cooperative Oncology Group \[ECOG\] grades 0, 1 and 2)
• 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.
• No evidence of distant metastasis on CECT.

You may not qualify if:

• Patient refused consent for the study
• Comorbid conditions which would preclude oesophagectomy
• Poor performance status (ECOG \> 2)
• American Society of Anesthesiologists class IV
• Metastatic disease detected on evaluation
• Involvement of mediastinal structures except
• Carcinoma involving cervical esophagus
• Previous radiotherapy or chemotherapy

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (1)

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110029, India

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms; Carcinoma, Squamous Cell

Interventions

Esophagectomy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Nikhil -, MS

  All India Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nikhil -, MS

CONTACT

91-9654055630; drnkhl@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 25, 2010
• First Posted: June 29, 2010
• Study Start: June 1, 2010
• Primary Completion: July 1, 2012
• Last Updated: July 12, 2010

Record last verified: 2010-06

Locations

IN (1)