Palliation Dysphagia Cancer Oesophagus Stent+Brachytherapy Versus Brachytherapy Only (PACO)

This study has been terminated.
(The study was closed prematurely due to slow recruitment)
Sponsor:
Collaborators:
Norwegian Cancer Society
Norwegian Foundation for Health and Rehabilitation
Information provided by (Responsible Party):
Cecilie Delphin Amdal, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00653107
First received: April 1, 2008
Last updated: April 12, 2012
Last verified: April 2012

April 1, 2008
April 12, 2012
June 2008
April 2012   (final data collection date for 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00653107 on ClinicalTrials.gov Archive Site
Health related quality of life [ Time Frame: 8 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Palliation Dysphagia Cancer Oesophagus Stent+Brachytherapy Versus Brachytherapy Only
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Esophageal Neoplasm
  • 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).
  • 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).
  • Experimental: A
    Stent followed by 3 brachytherapy fractions
    Interventions:
    • Procedure: Stent insertion
    • Radiation: Brachytherapy
  • Active Comparator: B
    3 fractions of brachytherapy
    Intervention: Radiation: Brachytherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
41
May 2020
April 2012   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00653107
FO2007/45, S-07447a
No
Cecilie Delphin Amdal, Oslo University Hospital
Oslo University Hospital
  • Norwegian Cancer Society
  • Norwegian Foundation for Health and Rehabilitation
Principal Investigator: Kristin Bjordal, PhD Radiumhospitalet. Rikshospitalet HF
Oslo University Hospital
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP