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

Esophageal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01151839
• Other study ID #: IESC/T-186/2010
• Status: Recruiting
• Phase: N/A
• First received: June 25, 2010
• Last updated: July 8, 2010
• Start date: June 2010

Study information

• Verified date: June 2010
• Source: All India Institute of Medical Sciences, New Delhi
• Contact: Nikhil -, MS
• Phone: 91-9654055630
• Email: drnkhl[@]gmail.com
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Esophageal Neoplasms

Intervention

Procedure:
• Esophagectomy
Patient with squamous cell carcinoma of esophagus will be treated with surgery alone
• Neoadjuvant chemoradiation followed by surgery
Patient with squamous cell carcinoma of esophagus will be treated by neoadjuvant chemoradiation followed by surgery

Locations

Country	Name	City	State
India	All India Institute of Medical Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
All India Institute of Medical Sciences, New Delhi

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resectability rate	To compare the resectability rate of carcinoma esophagus between patients randomized to surgery alone and neoadjuvant chemoradiation followed by surgery	2 years	No
Primary	postoperative morbidity	To compare the postoperative morbidity between patients of carcinoma esophagus randomized to surgery alone versus chemoradiation followed by surgery	2 Years	No
Primary	operative mortality	To compare the operative mortality between patients randomized to surgery alone and neoadjuvant chemoradiation followed by surgery.	2 Years	No
Secondary	Early disease control	To compare the early disease control in patients randomized to receive either neoadjuvant chemoradiation and surgery or surgery alone.	2 years	No
Secondary	Treatment toxicity	This study will also assess the treatment toxicity of preoperative chemoradiation	2 years	No