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
  Purpose

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 Intervention Phase
Esophageal Neoplasm
Procedure: Stent insertion
Radiation: Brachytherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

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. [ Time Frame: 8 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health related quality of life [ Time Frame: 8 years ] [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: June 2008
Estimated Study Completion Date: May 2020
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Stent followed by 3 brachytherapy fractions
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
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00653107

Locations
Norway
Radiumhospitalet
Oslo, Norway, N-0310
Sponsors and Collaborators
Oslo University Hospital
Norwegian Cancer Society
Norwegian Foundation for Health and Rehabilitation
Investigators
Principal Investigator: Kristin Bjordal, PhD Radiumhospitalet. Rikshospitalet HF
  More Information

No publications provided

Responsible Party: Cecilie Delphin Amdal, MD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT00653107     History of Changes
Other Study ID Numbers: FO2007/45, S-07447a
Study First Received: April 1, 2008
Last Updated: April 12, 2012
Health Authority: Norway: Data Protection Authority
Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Oslo University Hospital:
Palliation
Cancer oesophagus
Stent
Brachytherapy
Randomized

Additional relevant MeSH terms:
Esophageal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 23, 2014