Palliation Dysphagia Cancer Oesophagus Stent+Brachytherapy Versus Brachytherapy Only

Phase 3

Terminated

• Conditions: Esophageal Neoplasm
• Interventions: Radiation: Brachytherapy; Procedure: Stent insertion

• Registration Number: NCT00653107
• Lead Sponsor: Oslo University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-04-01
• Study First Submitted QC: 2008-04-03
• Study First Posted: 2008-04-04
• Study Start: 2008-06
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-11
• Last Update Posted: 2019-05-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

Patients must fulfill all the following criteria:

1. Histologically or cytologically verified carcinoma of the oesophagus

2. Reduced ability to swallow solid food, minimum grade 1 (see page 16)

3. Age ≥ 18 years

4. Ability to understand and answer (with or without help) the study questionnaires

5. Written informed consent received

6. A Completed questionnaire received from the patient

7. One of the following criteria must be fulfilled:

   1. Advanced disease and WHO performance status ≥2
   2. Advanced disease and WHO performance status 0-1 and other therapy excluded due to medical condition
   3. Advanced disease and WHO performance status 0-1 and patient's preference
   4. Local disease and WHO performance status ≥2 and other therapy excluded due to medical condition
   5. Local disease and WHO performance status ≥2 and patient's preference

Exclusion Criteria

1. Oesophageal stent already inserted
2. Endoscopic procedures not tolerated
3. Cannot have (additional) radiation therapy
4. Tumour location not suited for stent or brachytherapy (the upper 3 cm of oesophagus or major component in the cardia)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Brachytherapy	3 fractions of brachytherapy
A	Stent insertion	Stent followed by 3 brachytherapy fractions
A	Brachytherapy	Stent followed by 3 brachytherapy fractions

Primary Outcome Measures

Name	Time	Method
Dysphagia measured with the dysphagia grading scale at week +2 after start of treatment. Pain at rest measured with ESAS at week +2 after start of treatment.	8 years

Secondary Outcome Measures

Name	Time	Method
Health related quality of life	8 years

Trial Locations

Locations (1)

Radiumhospitalet; 🇳🇴 Oslo, Norway