Effect of preoperative concurrent chemoradiotherapy in patients with adenocarcinoma of esophagus
- Conditions
- Health Condition 1: null- patients with ECOG (0,1,2) - Good performance status
- Registration Number
- CTRI/2013/09/003981
- Lead Sponsor
- not applicable
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 160
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method resectability rate, postoperative morbidity and operative mortalityTimepoint: resectability rate, postoperative morbidity and operative mortality
- Secondary Outcome Measures
Name Time Method treatment compliance , early disease control (at 1 year) and assess the treatment toxicity of preoperative chemoradiation.Timepoint: till 2 years