Neoadjuvant Chemoradiotherapy Followed by Surgery Versus Active Surveillance for Oesophageal Cancer (SANO-trial): a Phase-III Stepped-wedge Cluster Randomised Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 776
- 试验地点
- 2
- 主要终点
- Overall survival
研究概览
简要总结
An active surveillance approach is proposed after completion of neoadjuvant chemoradiotherapy (nCRT) for carcinoma of the oesophagus. In this SANO (i.e. Surgery As Needed for Oesophageal cancer) approach, surgical resection is offered only to patients in whom a locoregional regrowth is highly suspected or proven, without distant dissemination. Such an organ-preserving strategy can have great advantages, but is only justified if long-term survival is non-inferior to that of the current standard trimodality approach comprising neoadjuvant chemoradiotherapy followed by standard surgery. The aim of this study is to assess the (cost-)effectiveness (including non-financial costs and survival) of active surveillance for patients with squamous cell- or adenocarcinoma of the oesophagus or oesophago-gastric junction.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who underwent or are planned to undergo neoadjuvant chemoradiotherapy according to CROSS and are planned to undergo potentially curative surgical resection for histologically proven oesophageal or junctional squamous cell carcinoma or adenocarcinoma are eligible. Whenever pathology is inconclusive but a multidisciplinary expert group concludes oesophageal carcinoma because of radiologically or endosonographically highly suspected lesions, patients are eligible for the study.
- •Written, voluntary, informed consent.
排除标准
- •Language difficulty, dementia or altered mental status prohibiting the understanding and giving of informed consent and to complete quality of life questionnaires;
- •Non-FDG-avid tumour at baseline PET-CT scan;
- •Initial treatment with endoscopic resection.
结局指标
主要结局
Overall survival
时间窗: the interval between the moment of achieving cCR (i.e. the moment the patient will start the intervention) and death or last follow-up, with a minimal follow-up of two years after reaching cCR.
次要结局
未报告次要终点
研究者
Jan van Lanschot
prof. dr.
Erasmus Medical Center