Randomised phase II trial testing efficacy of intra-tumoural hydrogen peroxide as a radiation sensitiser in patients with locally advanced or recurrent breast cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 184
- 试验地点
- 4
- 主要终点
- To test efficacy
研究概览
简要总结
This study is multi-centre, non-blinded, randomised trial with two groups comparing radiotherapy (RT) plus/minus radiation sensitizer.
Patients with poorly controlled symptoms of primary or recurrent locally advanced breast cancer requiring high dose RT for lifetime control of moderate or severe morbidities will be enrolled in the study.
Randomisation: Treatment allocation will be in a 1:1 ratio of RT alone versus same RT + KORTUC. Randomisation is performed by an interactive response technology (IRT) system.
Planned sample size globally is 184 subjects (92 in each randomised group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient age 18 years and over.
- •Primary locally advanced breast cancer, or locally recurrent breast cancer with/without metastases Radical/high dose palliative RT required for lifetime control of local morbidities.
- •Patient physically and mentally fit for radical/high dose palliative RT.
- •Target tumour accessible for intra-tumoural injection.
- •Patient suitable/compliant with MRI protocol At least one tumour diameter ≥30mm and ≤150mm measurable by ultrasound, MRI, CT or PET-CT Patients with predicted life expectancy of 12 months or more.
- •Negative pregnancy test before start of RT in women of child bearing potential and an ability/ willingness to protect against pregnancy from consent and for 3 months post-RT.
- •Documented informed consent obtained.
排除标准
- •Prior RT to the target area.
- •Maximum diameter of target tumour 150mm measurable by ultrasound, MRI, CT or PET-CT.
- •Anatomical location and/or extent of disease difficult to access for safe intra-tumoural drug injections, for example by virtue of contiguous major blood vessels and/or brachial plexus.
- •Concomitant chemotherapy or biological therapy except Herceptin, Pertuzumab and Denosumab (all endocrine therapies and bisphosphonates are allowed concomitantly; other cytotoxics and biological therapies apart from those mentioned above should be stopped 3 weeks prior to RT).
- •Pregnancy or nursing.
- •Hypersensitivity to any of the KORTUC ingredients.
结局指标
主要结局
To test efficacy
时间窗: Complete tumour response based on best response assessed by contrast enhanced MRI, according to criteria | outlined in protocol, performed up to and including 12 months post-RT.
次要结局
- To further characterise efficacy & safety(Overall survival at 6,12&24 months)