Palliation Dysphagia Cancer Oesophagus Stent+Brachytherapy Versus Brachytherapy Only

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2012-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Esophageal Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Stent followed by 3 brachytherapy fractions

Group Type EXPERIMENTAL

Stent insertion

Intervention Type PROCEDURE

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

Brachytherapy

Intervention Type RADIATION

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).

B

3 fractions of brachytherapy

Group Type ACTIVE_COMPARATOR

Brachytherapy

Intervention Type RADIATION

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).

Interventions

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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®.

Intervention Type PROCEDURE

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).

Intervention Type 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).

Intervention Type RADIATION

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No