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Preoperative Chemoradiation and Surgery Versus Surgery Alone in Squamous Cell Carcinoma of Oesophagus - A Randomized Controlled Trial


N/A
18 Years
65 Years
Open (Enrolling)
Both
Esophageal Neoplasms

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Trial Information

Preoperative Chemoradiation and Surgery Versus Surgery Alone in Squamous Cell Carcinoma of Oesophagus - A Randomized Controlled Trial


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 <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.

5. No evidence of distant metastasis on CECT.

Exclusion Criteria:

1. Patient refused consent for the study

2. Comorbid conditions which would preclude oesophagectomy

- Poor performance status (ECOG > 2)

- American Society of Anesthesiologists class IV

3. Metastatic disease detected on evaluation

4. Involvement of mediastinal structures except

5. Carcinoma involving cervical esophagus

6. Previous radiotherapy or chemotherapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Resectability rate

Outcome Description:

To compare the resectability rate of carcinoma esophagus between patients randomized to surgery alone and neoadjuvant chemoradiation followed by surgery

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Nikhil -, MS

Investigator Role:

Principal Investigator

Investigator Affiliation:

All India Institute of Medical Sciences, New Delhi

Authority:

India: Institutional Review Board

Study ID:

IESC/T-186/2010

NCT ID:

NCT01151839

Start Date:

June 2010

Completion Date:

Related Keywords:

  • Esophageal Neoplasms
  • Esophagus
  • squamous cell carcinoma
  • neoadjuvant chemoradiation
  • Neoplasms
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Esophageal Diseases
  • Esophageal Neoplasms

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