A Retrospective Non Interventional Study on First Line Treatment for Patients With BRAFV600E Mutant Metastatic Colorectal Cancer (mCRC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 274
- 试验地点
- 34
- 主要终点
- Treatment Patterns for First-line Systemic Anticancer Therapy (SACT) in BRAFV600E Mutant mCRC Patients
研究概览
简要总结
The presence of a BRAFV600E mutation is considered a marker of poor prognosis in patients with mCRC, and findings from clinical trials have largely remained inconclusive regarding the efficacy of first line treatments for BRAF-mutant mCRC patients. In the absence of targeted/specific treatment for BRAF-mutant mCRC, treatment practices can vary based on local practices and guidelines. There is, therefore, an unmet need to document the current practices for first-line treatment of BRAF-mutant mCRC, and their effectiveness and safety in a real-world setting.
This real-world, multicenter non-interventional study (NIS) will describe the treatment patterns, effectiveness and safety of current treatment regimens in BRAFV600E mutant mCRC patients in Europe, with the aim to put the clinical study findings of the ongoing Phase 2, single-arm, open label trial (ANCHOR) into context of the current treatment landscape excluding investigational therapies. Additionally, the NIS output may be used to support future health technology assessment submissions and publications.
详细描述
This retrospective, multi-center longitudinal study on BRAFV600E mutant mCRC patients will be conducted in Europe to characterize the first-line treatment patterns. All BRAFV600E mutant patients having initiated a first-line treatment for mCRC between January 1st, 2016 and December 31st, 2018 (both days inclusive) with drugs registered for mCRC in respective country will be eligible to participate. The study will not provide or recommend any treatment or procedure; all decisions regarding treatment are made at the sole discretion of the treating physician in accordance with their usual practices and all eligible patients will be considered for enrollment.
The target countries for patient enrollment will include Germany, France, Italy, United Kingdom, Spain, Belgium, Austria and the Netherlands. Approximately 300 adult patients (≥18 years) from a mix of academic and non-academic sites (up to 65 sites) will be enrolled.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Diagnosis of histologically or cytologically confirmed CRC that is metastatic and unresectable
- •Presence of BRAFV600E mutation in tumor tissue, as confirmed by a local assay
- •Initiated first-line treatment with drugs registered for mCRC in the respective country at the time of treatment between January 1st, 2016 and December 31st, 2018 (both days inclusive)
- •Provision of informed consent or non-opposition to the patient (or next of kin, if applicable) for the use of data, according to local regulations
排除标准
- •Patients will be excluded from the study if they fulfil any of the following criteria:
- •Patients with another concomitant cancer at the time of diagnosis*
- •Patients participating in interventional trials on investigational drugs at the time of initiation of first-line treatment
- •Except for non-metastatic non-melanoma skin cancers, or in situ or benign neoplasms; a cancer will be considered concomitant if it occurs within 5 years of mCRC diagnosis.
结局指标
主要结局
Treatment Patterns for First-line Systemic Anticancer Therapy (SACT) in BRAFV600E Mutant mCRC Patients
时间窗: time from treatment initiation (for mCRC) up to 31 December 2020
First-line SACT treatment patterns in BRAFV600E mutant mCRC patients described by agent or combination of agents received
Duration of Treatment for First-line Systemic Anticancer Therapy (SACT) in BRAFV600E Mutant mCRC Patients
时间窗: time from treatment initiation (for mCRC) up to 31 December 2020
First-line SACT treatment patterns in BRAFV600E mutant mCRC patients described by Duration of Treatment
Switch in mCRC First-line Systemic Anticancer Therapy (SACT) Treatment in BRAFV600E Mutant mCRC Patients
时间窗: time from treatment initiation (for mCRC) up to 31 December 2020
Switch in mCRC first-line SACT treatment in BRAFV600E mutant mCRC patients.
次要结局
- Description of BRAF Mutation Testing Procedure in Regards With the First-line Treatment in BRAFV600E Mutant mCRC Patients(from the date of the start of first-line treatment for mCRC until the end of first-line treatment up to 31 December 2020)
- Description of BRAF Mutation Testing Timing in Regards With the First-line Treatment in BRAFV600E Mutant mCRC Patients(from the date of the start of first-line treatment for mCRC until the end of first-line treatment up to 31 December 2020)
- Overall Survival (OS)(from the date of the start of first-line treatment for mCRC up to 31 December 2020)
- Demographic and Clinical Characteristics(from the date of the start of first-line treatment for mCRC up to 31 December 2020)
- Progression-free Survival (PFS)(from the date of the start of first-line treatment for mCRC up to 31 December 2020)
- Overall Response Rate (ORR)(from the date of the start of first-line treatment for mCRC until the end of first-line treatment up to 31 December 2020)
- Time to Treatment Cessation(from the date of the start of first-line treatment for mCRC until the documented disease progression up to 31 December 2020)