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

All India Institute Of Medical Science (AIIMS)

Status: Unknown

Conditions: Esophageal Neoplasms

Treatments: Procedure: Esophagectomy; Procedure: Neoadjuvant chemoradiation followed by surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT01151839

IESC/T-186/2010

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Surgery Alone

Active Comparator group

Treatment:

Procedure: Esophagectomy

Neoadjuvant chemoradiation followed by surgery

Active Comparator group

Treatment:

Procedure: Neoadjuvant chemoradiation followed by surgery