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Clinical Trials/CTRI/2013/09/003981
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

not applicable0 sites160 target enrollmentTBD

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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

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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