Palliation Dysphagia Cancer Oesophagus Stent+Brachytherapy Versus Brachytherapy Only (PACO)
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ClinicalTrials.gov Identifier: NCT00653107 |
Recruitment Status :
Terminated
(The study was closed prematurely due to slow recruitment)
First Posted : April 4, 2008
Last Update Posted : May 14, 2019
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Esophageal Neoplasm | Procedure: Stent insertion Radiation: Brachytherapy | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 41 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Palliation of Dysphagia in Patients With Advanced Cancer of the Oesophagus by Comparing Stent Followed by 3 Courses of Brachytherapy With 3 Courses of Brachytherapy Only. A Randomised Phase III Study (PACO) |
Study Start Date : | June 2008 |
Actual Primary Completion Date : | April 2012 |
Actual Study Completion Date : | April 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: A
Stent followed by 3 brachytherapy fractions
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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). |
Active Comparator: B
3 fractions of brachytherapy
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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). |
- 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. [ Time Frame: 8 years ]
- Health related quality of life [ Time Frame: 8 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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One of the following criteria must be fulfilled:
- Advanced disease and WHO performance status ≥2
- Advanced disease and WHO performance status 0-1 and other therapy excluded due to medical condition
- Advanced disease and WHO performance status 0-1 and patient's preference
- Local disease and WHO performance status ≥2 and other therapy excluded due to medical condition
- Local disease and WHO performance status ≥2 and patient's preference
Exclusion Criteria:
- Oesophageal stent already inserted
- Endoscopic procedures not tolerated
- Cannot have (additional) radiation therapy
- Tumour location not suited for stent or brachytherapy (the upper 3 cm of oesophagus or major component in the cardia)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00653107
Norway | |
Radiumhospitalet | |
Oslo, Norway, N-0310 |
Principal Investigator: | Kristin Bjordal, PhD | Radiumhospitalet. Rikshospitalet HF |
Responsible Party: | Cecilie Delphin Amdal, MD, Oslo University Hospital |
ClinicalTrials.gov Identifier: | NCT00653107 |
Other Study ID Numbers: |
FO2007/45 S-07447a |
First Posted: | April 4, 2008 Key Record Dates |
Last Update Posted: | May 14, 2019 |
Last Verified: | May 2019 |
Palliation Cancer oesophagus Stent Brachytherapy Randomized |
Esophageal Neoplasms Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms |
Digestive System Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms |