Skip to main content
OpenTrials
Completed

NCT Number: NCT01179074

Role of Radiotherapy Following Oesophageal Stenting in Cancer

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Oesophageal Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

New Delhi, National Capital Territory of Delhi, 110029, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oesophageal stenting with self expandable metal stent

Procedure

oesophageal stent placement for high grade dysphagia in inoperable oesophageal cancer

Other names: Ultraflex stent, Microvasive, Boston Scientific

Oesophageal stent followed by external beam radiotherapy

Procedure

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

Other names: External beam radiotherapy

Primary outcomes

  1. Relief of dysphagia

    Time frame: 1 week after intervention

    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

  2. Relief of dysphagia

    Time frame: 3 months following intervention

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

  3. Relief of dysphagia

    Time frame: 5 months after intervention

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

Secondary outcomes

  1. Survival

    Time frame: 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

Sponsors and collaborators

Lead sponsor

All India Institute of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Aug 11, 2010
Registry last updated
Aug 11, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.