Role of Radiotherapy Following Oesophageal Stenting in Cancer

Not Applicable

Completed

• Conditions: Oesophageal Cancer
• Interventions: Procedure: oesophageal stenting with self expandable metal stent; Procedure: Oesophageal stent followed by external beam radiotherapy

• Registration Number: NCT01179074
• Lead Sponsor: All India Institute of Medical Sciences, New Delhi

Brief 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.

Study Timeline

• Study Start: 2007-04
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2010-02
• Study First Submitted: 2010-05-25
• Study First Submitted QC: 2010-08-10
• Last Update Submitted: 2010-08-10
• Study First Posted: 2010-08-11
• Last Update Posted: 2010-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Oesophageal cancer patients with locally advanced unresectable cancer (such as invasion of tracheo-bronchial tree, aorta, pulmonary vascular structures, etc),
• Metastatic disease, and co-morbid conditions precluding major surgical procedure (such as severe cardiopulmonary, hepatic and renal diseases) with grade 3 and 4 dysphagia, were included in the trial.

Exclusion Criteria

• Patients with carcinoma of the cervical oesophagus and those who had already received prior radiotherapy, chemotherapy, or any other modality of treatment were excluded

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oesophageal stent alone	oesophageal stenting with self expandable metal stent	Patients of inoperable oesophageal cancer in this arm underwent oesophageal stenting with self expandable metal stents
Oesophageal stent followed by EBRT	oesophageal stenting with self expandable metal stent	Patients in this arm underwent oesophageal stenting with self expandable metal stents followed by external beam radiotherapy (30Gy/10#/2weeks)
Oesophageal stent followed by EBRT	Oesophageal stent followed by external beam radiotherapy	Patients in this arm underwent oesophageal stenting with self expandable metal stents followed by external beam radiotherapy (30Gy/10#/2weeks)

Primary Outcome Measures

Name	Time	Method
Relief of dysphagia	5 months after intervention	Dysphagia grades at 5 months will be assessed in the two groups

Secondary Outcome Measures

Name	Time	Method
Survival	From the date of diagnosis till death	Patients will be followed up at baseline, 1 week after oesophageal stenting, 1 week after completion of radiotherapy and 2 monthly thereafter till their death

Trial Locations

Locations (1)

Departments of Gastrointestinal surgery, Gastroenterology, Radiation Oncology, All India Institute of Medical Sciences; 🇮🇳 New Delhi, Delhi, India