Back to resultsA Trial to Compare Preoperative Chemoradiation and Surgery Versus Surgery Alone in Squamous Cell Carcinoma of Oesophagus
Primary Purpose
Esophageal Neoplasms
Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Esophagectomy
Neoadjuvant chemoradiation followed by surgery
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Neoplasms focused on measuring Esophagus, squamous cell carcinoma, neoadjuvant chemoradiation
Eligibility Criteria
Inclusion Criteria:
- Age < 65 years
- Squamous cell carcinoma
- Good performance status (Eastern Cooperative Oncology Group [ECOG] grades 0, 1 and 2)
- 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.
- No evidence of distant metastasis on CECT.
Exclusion Criteria:
- Patient refused consent for the study
Comorbid conditions which would preclude oesophagectomy
- Poor performance status (ECOG > 2)
- American Society of Anesthesiologists class IV
- Metastatic disease detected on evaluation
- Involvement of mediastinal structures except
- Carcinoma involving cervical esophagus
- Previous radiotherapy or chemotherapy
Sites / Locations
- All India Institute of Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Surgery Alone
Neoadjuvant chemoradiation followed by surgery
Arm Description
Outcomes
Primary Outcome Measures
Resectability rate
To compare the resectability rate of carcinoma esophagus between patients randomized to surgery alone and neoadjuvant chemoradiation followed by surgery
postoperative morbidity
To compare the postoperative morbidity between patients of carcinoma esophagus randomized to surgery alone versus chemoradiation followed by surgery
operative mortality
To compare the operative mortality between patients randomized to surgery alone and neoadjuvant chemoradiation followed by surgery.
Secondary Outcome Measures
Early disease control
To compare the early disease control in patients randomized to receive either neoadjuvant chemoradiation and surgery or surgery alone.
Treatment toxicity
This study will also assess the treatment toxicity of preoperative chemoradiation
Full Information
NCT ID
NCT01151839
First Posted
June 25, 2010
Last Updated
July 8, 2010
Sponsor
All India Institute of Medical Sciences, New Delhi
1. Study Identification
Unique Protocol Identification Number
NCT01151839
Brief Title
A Trial to Compare Preoperative Chemoradiation and Surgery Versus Surgery Alone in Squamous Cell Carcinoma of Oesophagus
Official Title
Preoperative Chemoradiation and Surgery Versus Surgery Alone in Squamous Cell Carcinoma of Oesophagus - A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
June 2010 (undefined)
Primary Completion Date
July 2012 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
All India Institute of Medical Sciences, New Delhi
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Neoplasms
Keywords
Esophagus, squamous cell carcinoma, neoadjuvant chemoradiation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Surgery Alone
Arm Type
Active Comparator
Arm Title
Neoadjuvant chemoradiation followed by surgery
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Esophagectomy
Intervention Description
Patient with squamous cell carcinoma of esophagus will be treated with surgery alone
Intervention Type
Procedure
Intervention Name(s)
Neoadjuvant chemoradiation followed by surgery
Intervention Description
Patient with squamous cell carcinoma of esophagus will be treated by neoadjuvant chemoradiation followed by surgery
Primary Outcome Measure Information:
Title
Resectability rate
Description
To compare the resectability rate of carcinoma esophagus between patients randomized to surgery alone and neoadjuvant chemoradiation followed by surgery
Time Frame
2 years
Title
postoperative morbidity
Description
To compare the postoperative morbidity between patients of carcinoma esophagus randomized to surgery alone versus chemoradiation followed by surgery
Time Frame
2 Years
Title
operative mortality
Description
To compare the operative mortality between patients randomized to surgery alone and neoadjuvant chemoradiation followed by surgery.
Time Frame
2 Years
Secondary Outcome Measure Information:
Title
Early disease control
Description
To compare the early disease control in patients randomized to receive either neoadjuvant chemoradiation and surgery or surgery alone.
Time Frame
2 years
Title
Treatment toxicity
Description
This study will also assess the treatment toxicity of preoperative chemoradiation
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age < 65 years
Squamous cell carcinoma
Good performance status (Eastern Cooperative Oncology Group [ECOG] grades 0, 1 and 2)
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.
No evidence of distant metastasis on CECT.
Exclusion Criteria:
Patient refused consent for the study
Comorbid conditions which would preclude oesophagectomy
Poor performance status (ECOG > 2)
American Society of Anesthesiologists class IV
Metastatic disease detected on evaluation
Involvement of mediastinal structures except
Carcinoma involving cervical esophagus
Previous radiotherapy or chemotherapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nikhil -, MS
Phone
91-9654055630
Email
drnkhl@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nikhil -, MS
Organizational Affiliation
All India Institute of Medical Sciences, New Delhi
Official's Role
Principal Investigator
Facility Information:
Facility Name
All India Institute of Medical Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110029
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nikhil, MS
Phone
91-9654055630
Email
drnkhl@gmail.com
First Name & Middle Initial & Last Name & Degree
Nikhil -, MS
12. IPD Sharing Statement
Learn more about this trial
A Trial to Compare Preoperative Chemoradiation and Surgery Versus Surgery Alone in Squamous Cell Carcinoma of Oesophagus
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