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

NCT ID: NCT01151839

Last Updated: 2010-07-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Surgery Alone

Group Type: ACTIVE_COMPARATOR

Esophagectomy

Intervention Type: PROCEDURE

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

Neoadjuvant chemoradiation followed by surgery

Group Type: ACTIVE_COMPARATOR

Neoadjuvant chemoradiation followed by surgery

Intervention Type: PROCEDURE

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

Interventions

Esophagectomy

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

Intervention Type: PROCEDURE

Neoadjuvant chemoradiation followed by surgery

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

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

All India Institute of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

AIIMS

Principal Investigators

Nikhil -, MS

Role: PRINCIPAL_INVESTIGATOR

All India Institute of Medical Sciences

Locations

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, India

Site Status: RECRUITING

Countries

India

Central Contacts

Nikhil -, MS

Role: CONTACT

drnkhl@gmail.com

91-9654055630

Facility Contacts

Nikhil, MS

Role: primary

drnkhl@gmail.com

91-9654055630

Other Identifiers

IESC/T-186/2010

Identifier Type: -

Identifier Source: org_study_id