CTRI/2014/01/004276
Recruiting
Phase 3
Role of PET/CT in assessment of metabolic response of neoadjuvant chemoradiotherapy in patients with carcinoma esophagus
All India Institute of Medical Sciences New Delhi0 sites50 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Carcinoma esophagus patients undergoing neoadjuvant chemoradiotherapy
- Sponsor
- All India Institute of Medical Sciences New Delhi
- Enrollment
- 50
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
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 \<90°, no obliteration of the triangular fat space between the esophagus, aorta, and spine), and pericardium, and no evidence of tracheobronchial fistula or tumor extension into the airway lumen.
- •5\.No evidence of distant metastasis on CECT.
Exclusion Criteria
- •1\.Comorbid conditions which would preclude esophagectomy
- •Poor performance status (ECOG \> 2\)
- •American Society of Anesthesiologists class IV
- •2\.Metastatic disease detected on evaluation
- •3\.Involvement of mediastinal structures
- •4\.Carcinoma involving cervical esophagus
- •5\.Previous radiotherapy or chemotherapy
Outcomes
Primary Outcomes
Not specified
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