Know Cancer

or
forgot password

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)


Phase 3
18 Years
N/A
Not Enrolling
Both
Esophageal Neoplasm

Thank you

Trial Information

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)


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Outcome Time Frame:

8 years

Safety Issue:

No

Principal Investigator

Kristin Bjordal, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Radiumhospitalet. Rikshospitalet HF

Authority:

Norway: Data Protection Authority

Study ID:

FO2007/45

NCT ID:

NCT00653107

Start Date:

June 2008

Completion Date:

May 2020

Related Keywords:

  • Esophageal Neoplasm
  • Palliation
  • Cancer oesophagus
  • Stent
  • Brachytherapy
  • Randomized
  • Neoplasms
  • Deglutition Disorders
  • Esophageal Diseases
  • Esophageal Neoplasms

Name

Location