ctDNA Guided Palliative Systemic Therapy Compared to Standard Care in Metastatic Cancer - The Randomized ctDNA-RECIST Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 167
- 试验地点
- 4
- 主要终点
- Compliance with protocol
研究概览
简要总结
A study investigating if analysis of circulating tumor DNA (ctDNA) can guide palliative treatment in patients with gastrointestinal cancer.
详细描述
Background:
Circulating tumor DNA, (ctDNA) has the potential to better monitor treatment efficacy compared to imaging, possibly sparing the patient for ineffective treatment and their associated toxicity an allowing for an early change of the treatment approach.
Based on multiple dataset we have defined ctDNA-RECIST - the ctDNA response evaluation criteria.
Aim: This phase II randomized trial evaluates the use of ctDNA Response Evaluation Criteria in Solid Tumors (ctDNA-RECIST) versus standard imaging-based RECIST to guide treatment decisions in patients with metastatic gastrointestinal cancers.
Design: Patients are randomized 1:1. Patients in Arm A are offered standard treatment with response evaluation according to the RECIST criteria based on imaging, and treatment pauses according to institutional guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Incurable metastatic gastrointestinal cancer
- •Indication for first or second-line systemic treatment
- •Measurable disease according to RECIST v.1.1
- •CT of chest and abdomen less than 30 days old at time of treatment initiation
- •Age at least 18 years
- •ECOG performance status 0-2
- •Clinically eligible systemic palliative treatment at investigators decision.
- •Adequate bone marrow, liver and renal function allowing systemic chemotherapy
- •Anticonception for fertile women and for male patients with a fertile partner. Intrauterine device, vasectomy of a female subject's male partner or hormonal contraceptive are acceptable
- •Written and verbally informed consent
排除标准
- •Incapacity, frailty, disability and comorbidity to a degree that according to the investigator is not compatible with combination chemotherapy
- •Other concurrent malignant tumor except non-melanoma skin cancer or carcinoma in situ cervicis uteri
- •Pregnant (positive pregnancy test) or breast-feeding women
结局指标
主要结局
Compliance with protocol
时间窗: 3 months
The fraction of participants in ARM B, who comply with the study procedures during the first 3 months after inclusion.
次要结局
- Number of treatment cycles(1 year)
- Response rate Arm A(1 year)
- ctDNA response rate Arm B(1 year)
研究者
Karen-Lise Garm Spindler
Professor
Aarhus University Hospital