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Trial Title:
A Trial to Compare Preoperative Chemoradiation and Surgery Versus Surgery Alone in Squamous Cell Carcinoma of Oesophagus
NCT ID:
NCT01151839
Condition:
Esophageal Neoplasms
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Neoplasms
Esophageal Squamous Cell Carcinoma
Conditions: Keywords:
Esophagus
squamous cell carcinoma
neoadjuvant chemoradiation
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Esophagectomy
Description:
Patient with squamous cell carcinoma of esophagus will be treated with surgery alone
Arm group label:
Surgery Alone
Intervention type:
Procedure
Intervention name:
Neoadjuvant chemoradiation followed by surgery
Description:
Patient with squamous cell carcinoma of esophagus will be treated by neoadjuvant
chemoradiation followed by surgery
Arm group label:
Neoadjuvant chemoradiation followed by surgery
Summary:
Carcinoma of the esophagus is the among the most common cancers in Indian population.
While adenocarcinoma is more common in western countries, in India squamous cell
carcinoma is the more frequent form. Surgery is the standard treatment in resectable
lesions, but survival is poor. Adjuvant and neoadjuvant treatment therapy is used with an
aim to improve the results. Though few randomized trials have addressed the issue of
neoadjuvant chemoradiotherapy, the methodology was inhomogeneous and the populations
studied were different. The investigators will be conducting a randomized controlled
trial in patients with squamous cell carcinoma of the esophagus. Preoperative
chemoradiation followed by surgery will be compared with surgery alone.
Criteria for 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 <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
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
All India Institute of Medical Sciences
Address:
City:
New Delhi
Zip:
110029
Country:
India
Status:
Recruiting
Contact:
Last name:
Nikhil, MS
Phone:
91-9654055630
Email:
drnkhl@gmail.com
Investigator:
Last name:
Nikhil -, MS
Email:
Principal Investigator
Start date:
June 2010
Lead sponsor:
Agency:
All India Institute of Medical Sciences, New Delhi
Agency class:
Other
Source:
All India Institute of Medical Sciences, New Delhi
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01151839
