NCT01179074

Role of Radiotherapy Following Oesophageal Stenting in Cancer

Palliative Stenting With or Without Radiotherapy for Inoperable Oesophageal Carcinoma: a Randomised Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: All India Institute of Medical Sciences · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

To assess the benefits of oesophageal stenting and external beam radiotherapy over oesophageal stenting alone in patients with inoperable oesophageal cancer

Detailed description

A majority of patients with oesophageal cancer present with inoperable disease and require rapid and long lasting palliation of dysphagia. STUDY AIM: To compare dysphagia relief in patients treated with oesophageal stenting and external beam radiotherapy (EBRT), versus oesophageal stenting alone and to assess overall survival, treatment related complications, and quality of life in the two groups. PATIENTS AND METHODS: Patients with inoperable oesophageal cancer with high grade dysphagia to be randomised to receive oesophageal stenting alone (Group I), versus a combination of stenting followed by EBRT (Group II). Dysphagia relief, treatment related complications, overall survival, and quality of life to be assessed in the two groups.

Conditions

• Oesophageal Cancer

Interventions

Type	Name	Description
PROCEDURE	oesophageal stenting with self expandable metal stent	oesophageal stent placement for high grade dysphagia in inoperable oesophageal cancer
PROCEDURE	Oesophageal stent followed by external beam radiotherapy	30 Gy in 10 fractions over 2 weeks administered in the stent followed by EBRT group

Timeline

• Start date: 2007-04-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2010-08-11
• Last updated: 2010-08-11

Locations

1 site across 1 country: India