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Palliation Dysphagia Cancer Oesophagus Stent+Brachytherapy Versus Brachytherapy Only

NCT00653107 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2019-05-14

No results posted yet for this study

Summary

We wish to improve the swallowing function of patients with advanced cancer of the oesophagus, by carrying out a randomised clinical study in which we compare primary stenting followed by brachytherapy in the stent, 8 G x 3 with standard brachytherapy 8 Gy x 3.

The aim of the study is to investigate whether patients who receive a stent followed by brachytherapy have a better swallowing function without more pain at week +2,compared to patients who receive brachytherapy alone.

Conditions

  • Esophageal Neoplasm

Interventions

PROCEDURE

Stent insertion

Self-expanding metal stents will be used. These will be of the type which the hospital at any given time uses, at present Ultraflex®.

RADIATION

Brachytherapy

a flexible applicator (with a diameter adapted to the stent's diameter) will be introduced into the oesophagus, so the applicator will be lying in the middle of the lumen of the stent. Thereafter, the flexible applicator is connected to a MicroSelectron afterloading device (Iridium-192), and the treatment is given with a high dose rate (\> 12 Gy/h).

RADIATION

Brachytherapy

a flexible applicator will be introduced into the oesophagus. The flexible applicator is connected to a MicroSelectron afterloading device (Iridium-192), and the treatment is given with a high dose rate (\> 12 Gy/h).

Sponsors & Collaborators

  • Norwegian Cancer Society

    collaborator OTHER

  • Norwegian Foundation for Health and Rehabilitation

    collaborator OTHER

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Kristin Bjordal, PhD · Radiumhospitalet. Rikshospitalet HF

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00653107 on ClinicalTrials.gov