Role of Radiotherapy Following Oesophageal Stenting in Cancer

This study has been completed.
Sponsor:
Information provided by:
All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT01179074
First received: May 25, 2010
Last updated: August 10, 2010
Last verified: February 2010
  Purpose

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


Condition Intervention
Oesophageal Cancer
Procedure: oesophageal stenting with self expandable metal stent
Procedure: Oesophageal stent followed by external beam radiotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Palliative Stenting With or Without Radiotherapy for Inoperable Oesophageal Carcinoma: a Randomised Trial

Resource links provided by NLM:


Further study details as provided by All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:
  • Relief of dysphagia [ Time Frame: 1 week after intervention ] [ Designated as safety issue: No ]

    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


  • Relief of dysphagia [ Time Frame: 3 months following intervention ] [ Designated as safety issue: No ]
    Dysphagia grades at 3 months will be assessed in the two groups

  • Relief of dysphagia [ Time Frame: 5 months after intervention ] [ Designated as safety issue: No ]
    Dysphagia grades at 5 months will be assessed in the two groups


Secondary Outcome Measures:
  • Survival [ Time Frame: From the date of diagnosis till death ] [ Designated as safety issue: No ]
    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


Enrollment: 84
Study Start Date: April 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Oesophageal stent alone
Patients of inoperable oesophageal cancer in this arm underwent oesophageal stenting with self expandable metal stents
Procedure: oesophageal stenting with self expandable metal stent
oesophageal stent placement for high grade dysphagia in inoperable oesophageal cancer
Other Name: Ultraflex stent, Microvasive, Boston Scientific
Active Comparator: Oesophageal stent followed by EBRT
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
oesophageal stent placement for high grade dysphagia in inoperable oesophageal cancer
Other Name: Ultraflex stent, Microvasive, Boston Scientific
Procedure: Oesophageal stent followed by external beam radiotherapy
30 Gy in 10 fractions over 2 weeks administered in the stent followed by EBRT group
Other Name: External beam radiotherapy

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01179074

Locations
India
Departments of Gastrointestinal surgery, Gastroenterology, Radiation Oncology, All India Institute of Medical Sciences
New Delhi, Delhi, India, 110029
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Investigators
Study Director: Tushar K Chattopadhyay, MS Head, Dept. G.I Surgery, All India Institute of Medical Sciences, New Delhi
  More Information

Publications:
Responsible Party: Prof. T.K.Chattopadhyay, Department of G.I.Surgery, All India Institute of Medical Sciences, New Delhi-110029
ClinicalTrials.gov Identifier: NCT01179074     History of Changes
Other Study ID Numbers: SEMSRT-1
Study First Received: May 25, 2010
Last Updated: August 10, 2010
Health Authority: India: Indian Council of Medical Research

Keywords provided by All India Institute of Medical Sciences, New Delhi:
palliation inoperable oesophageal cancer

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on September 18, 2014