Esophageal NeoplasmPhase 3PACONCT00653107
Palliation Dysphagia Cancer Oesophagus Stent+Brachytherapy Versus Brachytherapy Only
A Phase 3 study testing Stent insertion and Brachytherapy in people with Esophageal Neoplasm, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Neoplasm
- What is being tested?
- Stent insertion and Brachytherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteNorway
- Study dates
- Jun 2008to Apr 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- A Completed questionnaire received from the patient
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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)
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
- Being tested
- Stent insertion, Brachytherapy
- Keywords
- Palliation, Cancer oesophagus, Stent, Brachytherapy, Randomized
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stent insertionProcedure or surgery
Self-expanding metal stents will be used. These will be of the type which the hospital at any given time uses, at present Ultraflex®.
BrachytherapyRadiation
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).
BrachytherapyRadiation
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).
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Stent followed by 3 brachytherapy fractions Receives: Procedure: Stent insertion; Radiation: Brachytherapy |
| B | Active comparator | 3 fractions of brachytherapy Receives: Radiation: Brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 years
Secondary outcomes (1)
Health related quality of life
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2008 (estimated)
- Study startJun 2008
- Primary completionApr 2012
- Study completionApr 2012
Why it stopped: The study was closed prematurely due to slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal NeoplasmStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Cancer Society, Norwegian Foundation for Health and Rehabilitation
- Responsible party
- Principal investigator, Cecilie Delphin Amdal, Oslo University Hospital
- Investigators
- Kristin Bjordal, PhD, Principal investigator, Radiumhospitalet. Rikshospitalet HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00653107
- Sponsor's protocol ID
- FO2007/45
- Other IDs
- S-07447a
- Acronym
- PACO
- Status last verified
- May 2019
- First submitted
- 1 Apr 2008
- Last updated
- 14 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00653107
- Acronym / sponsor ID
- PACO / FO2007/45
- Conditions
- Esophageal Neoplasm
- Keywords
- Palliation, Cancer oesophagus, Stent, Brachytherapy, Randomized
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was closed prematurely due to slow recruitment
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Norwegian Cancer Society, Norwegian Foundation for Health and Rehabilitation
- Study start
- Jun 2008
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 4 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: Stent insertion, Radiation: BrachytherapyStent followed by 3 brachytherapy fractions |
| B | Active comparator | Radiation: Brachytherapy3 fractions of brachytherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stent insertionSelf-expanding metal stents will be used. These will be of the type which the hospital at any given time uses, at present Ultraflex®. | Procedure or surgery | A |
| Brachytherapya 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 | A |
| Brachytherapya 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). | Radiation | B |
Primary outcome
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
1 secondary outcome
Health related quality of life
Time frame: 8 years
Results and safety
The study was stopped early (reason given: The study was closed prematurely due to slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristin Bjordal, PhD principal investigator
Radiumhospitalet. Rikshospitalet HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Stent insertion and Brachytherapy in people with Esophageal Neoplasm, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was closed prematurely due to slow recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2019.