A Trial to Compare Preoperative Chemoradiation and Surgery Versus Surgery Alone in Squamous Cell Carcinoma of Oesophagus

Study Overview
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Brief Summary
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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.

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

Conditions
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Esophageal Neoplasms

Intervention / Treatment
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* Procedure: Esophagectomy
* Procedure: Neoadjuvant chemoradiation followed by surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Surgery Alone<br> | Procedure: Esophagectomy<br>* Patient with squamous cell carcinoma of esophagus will be treated with surgery alone<br>|
| Active Comparator: Neoadjuvant chemoradiation followed by surgery<br> | Procedure: Neoadjuvant chemoradiation followed by surgery<br>* Patient with squamous cell carcinoma of esophagus will be treated by neoadjuvant chemoradiation followed by surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resectability rate | To compare the resectability rate of carcinoma esophagus between patients randomized to surgery alone and neoadjuvant chemoradiation followed by surgery | 2 years | 
| postoperative morbidity | To compare the postoperative morbidity between patients of carcinoma esophagus randomized to surgery alone versus chemoradiation followed by surgery | 2 Years | 
| operative mortality | To compare the operative mortality between patients randomized to surgery alone and neoadjuvant chemoradiation followed by surgery. | 2 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early disease control | To compare the early disease control in patients randomized to receive either neoadjuvant chemoradiation and surgery or surgery alone. | 2 years | 
| Treatment toxicity | This study will also assess the treatment toxicity of preoperative chemoradiation | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophagus, squamous cell carcinoma, neoadjuvant chemoradiation