Status:
UNKNOWN
A Trial to Compare Preoperative Chemoradiation and Surgery Versus Surgery Alone in Squamous Cell Carcinoma of Oesophagus
Lead Sponsor:
All India Institute of Medical Sciences
Conditions:
Esophageal Neoplasms
Eligibility:
All Genders
18-65 years
Phase:
NA
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 fo...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01151839
Start Date
June 1 2010
Last Update
July 12 2010
Active Locations (1)
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1
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India, 110029