Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was closed prematurely due to slow recruitment
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Neoplasm | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brachytherapy | Radiation | — | UNRESOLVED |
| Stent insertion | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- Stent followed by 3 brachytherapy fractions
- interventionNames
- Procedure: Stent insertion
- Radiation: Brachytherapy
- type
- ACTIVE_COMPARATOR
- label
- B
- description
- 3 fractions of brachytherapy
- interventionNames
- Radiation: Brachytherapy
Primary outcomes (1)
- 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.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
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