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| ID | Type | Description | Link |
|---|---|---|---|
| S-07447a |
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The study was closed prematurely due to slow recruitment
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| Name | Class |
|---|---|
| Norwegian Cancer Society | OTHER |
| Norwegian Foundation for Health and Rehabilitation | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Stent followed by 3 brachytherapy fractions |
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| B | Active Comparator | 3 fractions of brachytherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stent insertion | 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®. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Health related quality of life | 8 years |
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Inclusion Criteria:
Patients must fulfill all the following criteria:
Histologically or cytologically verified carcinoma of the oesophagus
Reduced ability to swallow solid food, minimum grade 1 (see page 16)
Age ≥ 18 years
Ability to understand and answer (with or without help) the study questionnaires
Written informed consent received
A Completed questionnaire received from the patient
One of the following criteria must be fulfilled:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristin Bjordal, PhD | Radiumhospitalet. Rikshospitalet HF | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiumhospitalet | Oslo | N-0310 | Norway |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001918 | Brachytherapy |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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| Brachytherapy | 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). |
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| Brachytherapy | 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). |
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| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |