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A Trial to Compare Preoperative Chemoradiation and Surgery Versus Surgery Alone in Squamous Cell Carcinoma of Oesophagus
Conditions
Esophageal Neoplasms
Conditions: official terms
Carcinoma, Squamous Cell - Esophageal Neoplasms
Conditions: Keywords
Esophagus, squamous cell carcinoma, neoadjuvant chemoradiation
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Esophagectomy
Type: Procedure
Name: Neoadjuvant chemoradiation followed by surgery
Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 65 Years
Minimum Age: 18 Years
Gender: Both
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
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
Location
All India Institute of Medical Sciences
New Delhi, Delhi, India
Status: Recruiting
Contact: Nikhil , MS - 91-9654055630 - drnkhl@gmail.com
Start Date
June 2010
Sponsors
All India Institute of Medical Sciences, New Delhi
Source
All India Institute of Medical Sciences, New Delhi
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page