Clinical trial · Interventional
A Trial to Compare Preoperative Chemoradiation and Surgery Versus Surgery Alone in Squamous Cell Carcinoma of Oesophagus
Preoperative Chemoradiation and Surgery Versus Surgery Alone in Squamous Cell Carcinoma of Oesophagus - A Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Neoplasms | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Esophagectomy | Procedure | — | UNRESOLVED |
| Neoadjuvant chemoradiation followed by surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Surgery Alone
- interventionNames
- Procedure: Esophagectomy
- type
- ACTIVE_COMPARATOR
- label
- Neoadjuvant chemoradiation followed by surgery
- interventionNames
- Procedure: Neoadjuvant chemoradiation followed by surgery
Primary outcomes (3)
- measure
- Resectability rate
- timeFrame
- 2 years
- description
- To compare the resectability rate of carcinoma esophagus between patients randomized to surgery alone and neoadjuvant chemoradiation followed by surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
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