Role of Radiotherapy Following Oesophageal Stenting in Cancer

All India Institute of Medical Sciences84 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Oesophageal Cancer

Interventions

oesophageal stenting with self expandable metal stentPROCEDURE

oesophageal stent placement for high grade dysphagia in inoperable oesophageal cancer

Oesophageal stent followed by external beam radiotherapyPROCEDURE

30 Gy in 10 fractions over 2 weeks administered in the stent followed by EBRT group

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Departments of Gastrointestinal surgery, Gastroenterology, Radiation Oncology, All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, India

Outcomes

Primary Outcomes

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

Time frame: 1 week after intervention

Relief of dysphagia

Dysphagia grades at 3 months will be assessed in the two groups

Time frame: 3 months following intervention

Relief of dysphagia

Dysphagia grades at 5 months will be assessed in the two groups

Time frame: 5 months after intervention

Secondary Outcomes

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

Time frame: From the date of diagnosis till death

Data from ClinicalTrials.gov

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