Fruquintinib in Patients With Metastatic Colorectal Cancer: A Prospective, Multicenter, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- iOMEDICO AG
- 入组人数
- 150
- 试验地点
- 43
- 主要终点
- Real-world disease control rate (RW DCR)
研究概览
简要总结
FRUQUENT is an observational study in Germany. The goal of the study is to evaluate how well Fruquintinib works to treat patients with metastatic colorectal cancer that have previously been treated with available standard therapies.
To this end, it will be analyzed how well patients respond to the therapy in the clinical routine. Further points of interest to the study are survival data, safety data, the use of medical care facilities, and the quality of life of patients treated with Fruquintinib.
Participants will be treated as decided by the treating physician and according to their routine practice.
FRUQUENT is accompanied by a translational research project combining real-world clinical data with foundational research to stratify patient collectives in regards to the therapeutic benefit of fruquintinib.
详细描述
FRUQUENT is a prospective, multicenter, observational study in Germany, collecting real-world data of patients with metastatic colorectal cancer (mCRC) who receive fruquintinib according to the SmPC. The goal of the study is to analyze the effectiveness of the monotherapy with fruquintinib in adult patients with mCRC that have previously been treated with available standard therapies, including fluoropyrimidine, oxaliplatin-, and irintecan-based chemotherapies, anti-VEGF agents, and, if RAS wild-type, anti-EGFR agents. Moreover, the patients must have progressed on or be intolerant to treatment with either trifluridine/tipiracil or regorafenib.
All data for FRUQUENT will be obtained in routine clinical practice, allowing for a representative evaluation of the effectiveness of fruquintinib in a real-world setting. The study aims to recruit 150 patients in 50 practices (office based, oncology outpatient-centers or hospitals) to facilitate robust data.
The companion translational research project "FRUQUENT FUTURE" aims to identify patient collectives that benefit the most from a therapy with fruquintinib. To this end, archival tumor tissue and whole blood from routine blood draws is collected. Real-world clinical data on effectiveness is correlated with biomarker profiles of tumor tissues to determine biomarkers that are indicative of a response to fruquintinib. Longitudinal monitoring of circulating tumor DNA (ctDNA) will allow for an investigation of ctDNA as an indicator of benefit and response to fruquintinib.
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
- •Aged 18 years or older.
- •Indication and decision for therapy with fruquintinib in accordance with the current German SmPC of fruquintinib as monotherapy for patients with mCRC.
- •Prior treatment with available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan based chemotherapies, anti VEGF therapy, and if RAS wild-type, anti EGFR therapy.
- •Progression on or intolerance to treatment with either trifluridine/tipiracil and/or regorafenib.
- •Other criteria according to current SmPC.
- •Signed written informed consent.* * Patients are allowed to be enrolled up to 6 weeks after their first dose of fruquintinib. These patients cannot participate in the PRO assessments.
排除标准
- •Participation in an interventional clinical trial (except follow-up) within 30 days prior to enrollment or start of treatment with fruquintinib, whatever comes first.
- •Contraindications according to current SmPC.
结局指标
主要结局
Real-world disease control rate (RW DCR)
时间窗: Start of treatment to end of treatment (avg. 6 months)
The primary objective is to assess the effectiveness of fruquintinib in routine treatment. To this end, the real-world disease control rate will be analyzed, defined as the rate of complete response, partial response, or stable disease, either radiologically documented or clinically assessed by the treating physician.
次要结局
- Evaluation of prognostic and predictive biomarkers in archival tumor tissue(Baseline)
- Treatment reality objective: Time to ECOG performance status >/= 2(From start of enrolment to end of study (max. 33 months))
- Disease characteristics objective: Date of initial diagnosis, stage of initial diagnosis, date of diagnosis of advanced disease, time to diagnosis of metastatic disease(From start of enrolment to end of recruitment (approx. 24 months))
- Longitudinal monitoring of circulating tumor DNA(Baseline to end of study)
- Best response(Start of treatment to end of treatment (avg. 6 months))
- Overall response rate (ORR)(Start of treatment to end of treatment (avg. 6 months))
- Time to treatment failure (TTF)(Start of treatment to end of treatment (avg. 6 months))
- Time to next treatment (TTNT)(Start of treatment to start of subsequent antineoplastic therapy (max. 33 months))
- Progression-free survival (PFS)(Start of treatment to disease progression or death (max. 33 months))
- Overall survival (OS)(Start of treatment to death (max. 33 months))
- Adverse events (AEs) and serious adverse events (SAEs) according to NCI CTCAE(Start of treatment until 30 days after end of fruquintinib treatment (avg. 7 months))
- Adverse drug reaction (ADR) and serious adverse drug reactions (SADR) related to fruquintinib(Start of treatment to 30 days after end of fruquintinib treatment (avg. 7 months))
- Quality of life (QoL): Absolute values over time from baseline to end of study(Baseline to (individual) end of study (max. 33 months))
- Quality of life (QoL): Change from baseline over time to end of study(Baseline to (individual) end of study (max. 33 months))
- Quality of life (QoL): Time to definitive deterioration (TTD)(Baseline to (individual) end of study (max. 33 months))
- Frequency of parameters affecting physicians' treatment decision making(Baseline)
- Fruiquintinib therapy duration(Start of treatment to end of treatment (avg. 6 months))
- Frequency of subsequent antineoplastic therapies(From date of end of fruquintinib treatment until end of study (max. 33 months))
- Frequency of treatment modifications of fruquintinib therapy(Start of treatment to end of treatment (avg. 6 months))
- Frequency of prior therapies according to type, setting and substance(Baseline)
- Duration of first subsequent therapy(From date of end of fruquintinib treatment until end of first subsequent therapy (max. 33 months))
- Frequency of hospitalizations and emergency unit visits(Start of treatment to end of treatment (avg. 6 months))
- Duration of hospitalizations(Start of treatment to end of treatment (avg. 6 months))