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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery Alone | Active Comparator |
| |
| Neoadjuvant chemoradiation followed by surgery | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esophagectomy | Procedure | Patient with squamous cell carcinoma of esophagus will be treated with surgery alone |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Patient refused consent for the study
Comorbid conditions which would preclude oesophagectomy
Metastatic disease detected on evaluation
Involvement of mediastinal structures except
Carcinoma involving cervical esophagus
Previous radiotherapy or chemotherapy
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nikhil -, MS | Contact | 91-9654055630 | drnkhl@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Nikhil -, MS | All India Institute of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| All India Institute of Medical Sciences | Recruiting | New Delhi | National Capital Territory of Delhi | 110029 | India |
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| Neoadjuvant chemoradiation followed by surgery | Procedure | Patient with squamous cell carcinoma of esophagus will be treated by neoadjuvant chemoradiation followed by surgery |
|
| 2 years |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |
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| ID | Term |
|---|---|
| D016629 | Esophagectomy |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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