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

• ClinicalTrials.gov Identifier: NCT00653107
• Recruitment Status: Terminated
• First Posted: April 4, 2008
• Last Update Posted: May 14, 2019
• Sponsor: Oslo University Hospital
• Collaborators: Norwegian Cancer Society; Norwegian Foundation for Health and Rehabilitation
• Information provided by (Responsible Party): Cecilie Delphin Amdal, Oslo University Hospital

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.

Condition or disease	Intervention/treatment	Phase
Esophageal Neoplasm	Procedure: Stent insertion; Radiation: Brachytherapy	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 41 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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)
• Study Start Date: June 2008
• Actual Primary Completion Date: April 2012
• Actual Study Completion Date: April 2012

Arms and Interventions

Arm	Intervention/treatment
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).

Outcome Measures

Primary Outcome Measures :

1. 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 Measures :

1. Health related quality of life [ Time Frame: 8 years ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Cecilie Delphin Amdal, MD, Oslo University Hospital
• ClinicalTrials.gov Identifier: NCT00653107
• Other Study ID Numbers: FO2007/45; S-07447a
• First Posted: April 4, 2008
• Last Update Posted: May 14, 2019
• Last Verified: May 2019

Keywords provided by Cecilie Delphin Amdal, Oslo University Hospital:

Palliation; Cancer oesophagus; Stent; Brachytherapy; Randomized

Additional relevant MeSH terms:

Esophageal Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms