Back to resultsPalliation Dysphagia Cancer Oesophagus Stent+Brachytherapy Versus Brachytherapy Only (PACO)
Primary Purpose
Esophageal Neoplasm
Status
Terminated
Phase
Phase 3
Locations
Norway
Study Type
Interventional
Intervention
Stent insertion
Brachytherapy
Brachytherapy
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Neoplasm focused on measuring Palliation, Cancer oesophagus, Stent, Brachytherapy, Randomized
Eligibility Criteria
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:
- 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)
Sites / Locations
- Radiumhospitalet
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A
B
Arm Description
Stent followed by 3 brachytherapy fractions
3 fractions of brachytherapy
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Health related quality of life
Full Information
NCT ID
NCT00653107
First Posted
April 1, 2008
Last Updated
May 11, 2019
Sponsor
Oslo University Hospital
Collaborators
Norwegian Cancer Society, Norwegian Foundation for Health and Rehabilitation
1. Study Identification
Unique Protocol Identification Number
NCT00653107
Brief Title
Palliation Dysphagia Cancer Oesophagus Stent+Brachytherapy Versus Brachytherapy Only
Acronym
PACO
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 Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Why Stopped
The study was closed prematurely due to slow recruitment
Study Start Date
June 2008 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Norwegian Cancer Society, Norwegian Foundation for Health and Rehabilitation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Neoplasm
Keywords
Palliation, Cancer oesophagus, Stent, Brachytherapy, Randomized
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Stent followed by 3 brachytherapy fractions
Arm Title
B
Arm Type
Active Comparator
Arm Description
3 fractions of brachytherapy
Intervention Type
Procedure
Intervention Name(s)
Stent insertion
Intervention Description
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
Radiation
Intervention Name(s)
Brachytherapy
Intervention Description
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
Intervention Name(s)
Brachytherapy
Intervention Description
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).
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Health related quality of life
Time Frame
8 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin Bjordal, PhD
Organizational Affiliation
Radiumhospitalet. Rikshospitalet HF
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radiumhospitalet
City
Oslo
ZIP/Postal Code
N-0310
Country
Norway
12. IPD Sharing Statement
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Palliation Dysphagia Cancer Oesophagus Stent+Brachytherapy Versus Brachytherapy Only
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