Palliation Dysphagia Cancer Oesophagus Stent+Brachytherapy Versus Brachytherapy Only - Full Text View

Sponsors and Collaborators:	Rikshospitalet HF Norwegian Cancer Society
Information provided by:	Rikshospitalet HF
ClinicalTrials.gov Identifier:	NCT00653107

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
Neoplasms of the Oesophagus	Procedure: Stent insertion Radiation: Brachytherapy	Phase III

MedlinePlus related topics: Cancer Esophageal Cancer Swallowing Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
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)

Further study details as provided by Rikshospitalet HF:

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 ]

Estimated Enrollment:	90
Study Start Date:	May 2008
Estimated Study Completion Date:	May 2020
Estimated Primary Completion Date:	April 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental 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).
B: Active Comparator 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).

Arms

Assigned Interventions

A: Experimental

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).

B: Active Comparator

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:

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:
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:

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)

Contacts and Locations

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

Contacts

Contact: Cecilie D Amdal, MD

+4722934000

cecilie.delphin.amdal@radiumhospitalet.no

Locations

Norway
Radiumhospitalet
Oslo, Norway, N-0310

Sponsors and Collaborators

Rikshospitalet HF

Norwegian Cancer Society

Investigators

Principal Investigator:

Kristin Bjordal, PhD

Radiumhospitalet. Rikshospitalet HF

More Information

Responsible Party:	Rikshospitalet-Radiumhospitalet HF ( Division head Sigbjørn Smeland MD PhD )
Study ID Numbers:	FO2007/45, S-07447a
Study First Received:	April 1, 2008
Last Updated:	April 3, 2008
ClinicalTrials.gov Identifier:	NCT00653107
Health Authority:	Norway: Data Inspectorate; Norway: The National Committees for Research Ethics in Norway

Keywords provided by Rikshospitalet HF:

Palliation
Cancer oesophagus
Stent
Brachytherapy
Randomized

Study placed in the following topic categories:

Deglutition Disorders
Digestive System Diseases
Digestive System Neoplasms
Esophageal disorder
Gastrointestinal Diseases

Head and Neck Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Esophageal Diseases
Esophageal neoplasm

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009