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)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •Advanced disease and WHO performance status ≥2
- •Advanced disease and WHO performance status 0-1 and other therapy excluded due to medical condition
- •Advanced disease and WHO performance status 0-1 and patient's preference
- •Local disease and WHO performance status ≥2 and other therapy excluded due to medical condition
- •Local disease and WHO performance status ≥2 and patient's preference
排除标准
- •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)
研究组 & 干预措施
B
3 fractions of brachytherapy
干预措施: Brachytherapy (Radiation)
A
Stent followed by 3 brachytherapy fractions
干预措施: Stent insertion (Procedure)
A
Stent followed by 3 brachytherapy fractions
干预措施: Brachytherapy (Radiation)
结局指标
主要结局
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.
时间窗: 8 years
次要结局
- Health related quality of life(8 years)
研究者
Cecilie Delphin Amdal
MD
Oslo University Hospital