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

University of Oslo (UIO)

Status and phase: Terminated; Phase 3

Conditions: Esophageal Neoplasm

Treatments: Procedure: Stent insertion; Radiation: Brachytherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00653107

FO2007/45

S-07447a

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

A

Experimental group

Description:

Stent followed by 3 brachytherapy fractions

Treatment:

Radiation: Brachytherapy

Procedure: Stent insertion

Radiation: Brachytherapy

B

Active Comparator group

Description:

3 fractions of brachytherapy

Treatment:

Radiation: Brachytherapy

Radiation: Brachytherapy