A Prospective Cohort Study on Active Surveillance After Neoadjuvant Chemoradiation for Oesophageal Cancer: SANO-2 Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Safety of active surveillance (including delayed surgery), measured by the number of patients with adverse events
研究概览
简要总结
A prospective cohort study on active surveillance after neoadjuvant chemoradiation for oesophageal cancer: SANO-2 study.
详细描述
An active surveillance approach after completion of neoadjuvant chemoradiotherapy for locally advanced oesophageal cancer is being investigated in the SANO (Surgery As Needed for Oesophageal cancer) trial, that completed patient inclusion in December 2020. First long term results are expected end 2023. Based on current retrospective studies and short term results of the SANO, to date there is no evidence that active surveillance is unsafe. Within the follow-up of the SANO trial, the safety of active surveillance is continuously monitored. Based on a high participation rate (>90%) in the SANO trial and on the view of the Dutch patient federation for cancer of the digestive tract (SPKS) to offer active surveillance as an alternative treatment option in a controlled setting, there is a demand for a tailored surgery approach after neoadjuvant chemoradiotherapy until results of the SANO trial are available. When patients request active surveillance outside the SANO trial, it is of the utmost importance to set up a prospective cohort study (extension study) in order to monitor safety, implementation and effectiveness of active surveillance outside the SANO trial before the final results of the SANO trail are available.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Operable patients who are planned to undergo or who recently underwent neoadjuvant chemoradiotherapy according to CROSS followed by surgical resection for histologically proven oesophageal squamous cell carcinoma or adenocarcinoma of the oesophagus or oesophago-gastric junction
- •Written, voluntary, informed consent.
排除标准
- •Non-FDG-avid tumour at baseline PET-CT scan
- •Initial treatment with endoscopic resection
- •Patients who underwent of who are planned to undergo definitive chemoradiotherapy
- •Language difficulty, dementia or altered mental status prohibiting the understanding and giving of informed consent.
结局指标
主要结局
Safety of active surveillance (including delayed surgery), measured by the number of patients with adverse events
时间窗: after the procedure/surgery and at least up to 2 years
Including: * Complications from OGD with bite-on-bite biopsies, EUS-FNA and PET-CT * Unresectable or incurable (T4b or R2) regrowth * Microscopically non-radical (R1) resection * Postoperative mortality (90 day- or in-hospital mortality) * Postoperative hospital stay of \>60 days * Postoperative complications, defined by the Esophagectomy Complications Consensus Group (ECCG) * Development of distant metastases
次要结局
- The proportion of patients in the active surveillance strategy that opted for decision counseling(at least up to 2 years)
- Regret of the decision to undergo active surveillance(at least up to 2 years)
- The proportion of patients that opted for decision counselling as well as the proportion of patients who switched from preferring active surveillance to preferring immediate surgery or vice versa.(at least up to 2 years)
- The proportion of performed FNA in case of suspected lymph nodes(after the procedure and at least up to 2 years)
- Rate of distant and locoregional relapse(at least up to 2 years)
- Progression-free survival (PFS)(From cCR until the date of first documented disease progression or date of death from any cause, whichever came first, assessed at least up to 2 years)
- Overall survival (OS)(From cCR until the date of death from any cause, assessed at least up to 2 years)
- Fear of recurrence of cancer(at least up to 2 years)
- The proportion of all performed endoscopies with at least 4 bite-on-bite biopsies taken(after the procedure and at least up to 2 years)
- Regret of the decision to undergo surgery(at least up to 2 years)
- The proportion of performed endoscopic reports which are complete(after the procedure and at least up to 2 years)
- The number of biopsies taken and quality of the biopsies(after the procedure and at least up to 2 years)
- The proportion of participating patients in the SANO-2 study who meet all eligibility criteria(after the procedure and at least up to 2 years)
- The proportion of all performed CREs performed in correct order(after the procedure and at least up to 2 years)
- The proportion of performed diagnostic modalities performed at appropriate time(after the procedure and at least up to 2 years)
研究者
Bas P. L. Wijnhoven
Principal Investigator
Erasmus Medical Center