CTRI/2013/09/003981
Recruiting
未知
Preoperative chemoradiation and surgery versus surgery alone in gastroesophageal junction adenocarcinoma of oesophagus â??A Randomized controlled trial
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- patients with ECOG (0,1,2) - Good performance status
- Sponsor
- not applicable
- Enrollment
- 160
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Age \< 70 years
- •2\.Adenocarcinoma
- •3\.Good performance status (Eastern Cooperative Oncology Group \[ECOG] grades 0, 1 and 2\) i.e the patient should not be spending more than 50% of his time in Bed.
- •4\.Swallowing capacity at preop or preop neoadjuvant is a minimum of oral intake (liquid or semisolid)
- •5\.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 pericardium, and no evidence of tracheobronchial fistula or tumor extension into the airway lumen.
- •6\.No evidence of distant metastasis on CECT of neck , thorax and abdomen.
Exclusion Criteria
- •1\.Patient refuses consent for the study
- •2\.Co\-morbid conditions which would preclude oesophagectomy
- •a.Poor performance status (ECOG \> 2\)
- •b.American Society of Anesthesiologists class IV
- •3\.Metastatic disease detected on evaluation
- •4\.Involvement of mediastinal structures as described in the inclusion criteria
- •5\.Carcinoma involving upper third of the esophagus.
- •6\.Previous radiotherapy or chemotherapy
Outcomes
Primary Outcomes
Not specified
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