NCT04084249进行中（未招募）不适用
Implementing Non-invasive Circulating Tumor DNA Analysis to Optimize the Operative and Postoperative Treatment for Patients With Colorectal Cancer - Intervention Trial 2
Claus Lindbjerg Andersen20 个研究点 分布在 1 个国家目标入组 359 人开始时间: 2020年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 359
- 试验地点
- 20
- 主要终点
- FCI
研究概览
简要总结
IMPROVE-IT2 is a randomized multicenter trial comparing the outcomes of ctDNA guided post-operative surveillance and standard-of-care CT-scan surveillance. The hypothesis of this study is that ctDNA guided post-operative surveillance combining ctDNA and radiological assessments could result in earlier detection of recurrent disease and identify more patients eligible for curative treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Colon or rectal cancer, tumor stage III (pT1-4N1-2,cM0) or stage II high-risk (pT4N0,cM0 and pT3N0, cM0 with risk factors)
- •Have received curative intend resection and be candidates for adjuvant chemotherapy
排除标准
- •Not treated with adjuvant chemotherapy
- •Synchronous colorectal and non-colorectal cancer diagnosed per-operative (except skin cancer other than melanoma)
- •Other cancers (excluding colorectal cancer or skin cancer other than melanoma) within 3 years from screening
- •Patients who are unlikely to comply with the protocol (e.g. uncooperative attitude), inability to return for subsequent visits) and/or otherwise considered by the Investigator to be unlikely to complete the study.
结局指标
主要结局
FCI
时间窗: 5 years
Fraction of patients with relapse receiving intended curative resection or local treatment aiming at complete tumor destruction as defined at the relevant MDT conference.
次要结局
- TTMR(2 years)
- 3yr-OS(3 years)
- CE(5 years)
- AR(3 years)
- TTCR(3 years)
- 5yr-OS(5 years)
- FCRI(3 years)
- QoL(3 years)
- IES-C(3 years)
研究者
Claus Lindbjerg Andersen
Professor
Aarhus University Hospital
研究点 (20)
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