Role of Radiotherapy Following Oesophageal Stenting in Cancer

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

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

Study Overview

• Status: Completed
• Conditions: Oesophageal Cancer
• Intervention / Treatment: Procedure: oesophageal stenting with self expandable metal stent; Procedure: Oesophageal stent followed by 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.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110029
      • Departments of Gastrointestinal surgery, Gastroenterology, Radiation Oncology, All India Institute of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: 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 Names: External beam radiotherapy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• Schmid EU, Alberts AS, Greeff F, Terblanche AP, Schoeman L, Burger W, Shiels RA, Friediger D, Van der Hoven A, Falkson G. The value of radiotherapy or chemotherapy after intubation for advanced esophageal carcinoma--a prospective randomized trial. Radiother Oncol. 1993 Jul;28(1):27-30. doi: 10.1016/0167-8140(93)90181-7.

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: May 25, 2010
• First Submitted That Met QC Criteria: August 10, 2010
• First Posted (Estimate): August 11, 2010

Study Record Updates

• Last Update Posted (Estimate): August 11, 2010
• Last Update Submitted That Met QC Criteria: August 10, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: palliation inoperable oesophageal cancer
• Other Study ID Numbers: SEMSRT-1