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

Not Applicable

• Conditions: Esophageal Neoplasms
• Interventions: Procedure: Esophagectomy; Procedure: Neoadjuvant chemoradiation followed by surgery

• Registration Number: NCT01151839
• Lead Sponsor: All India Institute of Medical Sciences, New Delhi

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-06
• Study Start: 2010-06
• Study First Submitted: 2010-06-25
• Study First Submitted QC: 2010-06-28
• Study First Posted: 2010-06-29
• Last Update Submitted: 2010-07-08
• Last Update Posted: 2010-07-12
• Primary Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgery Alone	Esophagectomy	-
Neoadjuvant chemoradiation followed by surgery	Neoadjuvant chemoradiation followed by surgery	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

All India Institute of Medical Sciences; 🇮🇳 New Delhi, Delhi, India