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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01151839

Enrollment

100

Registered

2010-06-29

Start date

2010-06-30

Completion date

Unknown

Last updated

2010-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Neoplasms

Keywords

Esophagus, squamous cell carcinoma, neoadjuvant chemoradiation

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.

Interventions

PROCEDUREEsophagectomy

Patient with squamous cell carcinoma of esophagus will be treated with surgery alone

PROCEDURENeoadjuvant chemoradiation followed by surgery

Patient with squamous cell carcinoma of esophagus will be treated by neoadjuvant chemoradiation followed by surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

India

Contacts

Primary ContactNikhil -, MS

drnkhl@gmail.com91-9654055630

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026