Role of Radiotherapy Following Oesophageal Stenting in Cancer

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

Detailed Description
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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.

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

Conditions
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Oesophageal Cancer

Intervention / Treatment
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* Procedure: oesophageal stenting with self expandable metal stent
* Procedure: Oesophageal stent followed by external beam radiotherapy


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oesophageal stent alone<br>Patients of inoperable oesophageal cancer in this arm underwent oesophageal stenting with self expandable metal stents | Procedure: oesophageal stenting with self expandable metal stent<br>* oesophageal stent placement for high grade dysphagia in inoperable oesophageal cancer<br>* Other names: Ultraflex stent, Microvasive, Boston Scientific;|
| Active Comparator: Oesophageal stent followed by EBRT<br>Patients in this arm underwent oesophageal stenting with self expandable metal stents followed by external beam radiotherapy (30Gy/10#/2weeks) | Procedure: oesophageal stenting with self expandable metal stent<br>* oesophageal stent placement for high grade dysphagia in inoperable oesophageal cancer<br>* Other names: Ultraflex stent, Microvasive, Boston Scientific;Procedure: Oesophageal stent followed by external beam radiotherapy<br>* 30 Gy in 10 fractions over 2 weeks administered in the stent followed by EBRT group<br>* Other names: External beam radiotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relief of dysphagia | Relief of dysphagia will be assessed by stratifying the ability to swallow into the following grades. Grade 1: Difficulty in swallowing solid food Grade 2: Difficulty in swallowing semisolid food Grade 3: Difficulty in swallowing liquids Grade 4: Difficulty in swallowing even saliva The dysphagia scores will be assessed 1 week after intervention (stenting and radiotherapy)in the two groups | 1 week after intervention | 
| Relief of dysphagia | Dysphagia grades at 3 months will be assessed in the two groups | 3 months following intervention | 
| Relief of dysphagia | Dysphagia grades at 5 months will be assessed in the two groups | 5 months after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | 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 | From the date of diagnosis till death | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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palliation inoperable oesophageal cancer