RegoFlex EU/Real World Evidence on Stivarga Flexible Dosing in Patients With Metastatic Colorectal Cancer in Europe
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Dose at treatment end (last prescribed regorafenib dose): 40, 80, 120, or 160 mg
研究概览
简要总结
This is an observational study in which data from patients with metastatic colorectal cancer in three European countries who received STIVARGA® (regorafenib), are collected. In observational studies, only observations are made without specified advice or interventions.
Metastatic colorectal cancer (mCRC) is a cancer that starts in the large bowel or the rectum (the lowest part of the gut) and has spread to other parts of the body. Regorafenib is an anti-cancer drug that blocks several proteins called enzymes, which are involved in the development and growth of cancer. A wide range of such enzymes called tyrosine kinases are targeted.
In 2013, regorafenib was approved in Europe for doctors to prescribe to people with mCRC who have previously been treated or cannot receive other available treatments. It is known that doctors may change/reduce the amount (the dose) of regorafenib they give (flexible dosing), so that the patients better tolerate the treatment. However, little information is available on the doses of regorafenib given in France, Italy, and Belgium in usual practice.
In this study researchers want to learn more about how and in which amount regorafenib is usually given to patients with mCRC in France, Italy, and Belgium:
- at the beginning
- during, and
- at the end of the regorafenib therapy.
In addition, the study team will collect data about/if:
- the treatment duration at each treatment dose of regorafenib,
- the number of people who received reduced initial dosing of regorafenib in real word settings in France, Italy, and Belgium,
- reduced (flexible) initial dosing of regorafenib allows patients to stay longer on treatment.
To answer these questions, the researchers will look back at cases that have already happened when the study begins. The data will be collected through an online case report form. The doctors will provide case histories of mCRC patients who started regorafenib treatment in most recent 3 years and 4 months (from January 1, 2019 to Apr 30, 2022) or up until 3 months prior to the date of data collection.
Besides this data collection, no further tests or examinations are planned in this study.
There are no required visits or tests in this study.
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
- •Patients with a histopathological or cytological diagnosis of colorectal cancer and metastatic disease (stages IVA, IVB, or IVC)
- •Patients must have initiated regorafenib as monotherapy, regardless of line of therapy, from January 1, 2019 to December 31, 2021 (or up until 3 months prior to date of data collection, whichever occurs latest)
- •Aged ≥18 years at index date
排除标准
- •Patients with regorafenib treatment prior to January 1, 2019
- •Patients who have participated in a clinical trial
结局指标
主要结局
Dose at treatment end (last prescribed regorafenib dose): 40, 80, 120, or 160 mg
时间窗: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
Average dose intensity at first and subsequent cycles
时间窗: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
The sum of dose strength (mg) will be divided by the days on therapy in each cycle.
Duration of treatment (DoT)
时间窗: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
Duration of treatment: time (months) from date of initial regorafenib dose to date of last dose prior to a \>2-week gap during the follow up period.
Time to discontinuation (TTD)
时间窗: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
Time to discontinuation: time (months) from date of initial regorafenib dose to date of discontinuation (as indicated by CRF)
Time to first full dose of 160 mg
时间窗: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
Time to 1st full dose of 160 mg: time (months) from date of initial regorafenib dose to 1st full dose of 160 mg during the treatment history among patients with 40, 80, or 120 mg initial dose, overall and by initial dose.
Proportion of patients initiating a flexible regorafenib dose (40, 80, or 120 mg) versus 160 mg
时间窗: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
Time to first dose change
时间窗: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
Time to first dose change: time (months) from date of initial regorafenib dose to 1st dose increase/decrease among patients initiating a flexible regorafenib dose (40, 80, or 120 mg)
Number of cycles received
时间窗: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
Proportion of patients initiating 1, 2, 3, or more cycles
时间窗: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
The label recommended regorafenib treatment cycle is 28 days.
Proportion of patients with reasons for discontinuation
时间窗: Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)
Reasons for discontinuation includes: distant progression/relapse, local progression/relapse, patient choice to discontinue therapy, poor performance status, side effects, new primary malignancy, death, lost to follow up, coronavirus disease 2019 (COVID-19)-related and other.
次要结局
- Descriptive summary of demographics characteristics(Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest))
- Descriptive summary of K-RAS mutation status and N-RAS mutation status(Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest))
- Descriptive summary of Line of therapy (LOT) for regorafenib(Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest))
- Descriptive summary of Pre-existing comorbidities(Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest))
- Descriptive summary of Stage of disease(Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest))
- Descriptive summary of Primary tumor status(Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest))
- Descriptive summary of Number of metastatic(Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest))
- Descriptive summary of Site of metastasis(Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest))
- Descriptive summary of Eastern Cooperative Oncology Group (ECOG) performance status(Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest))
- Descriptive summary of Prior adjuvant treatment(Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest))
- Descriptive summary of Treatments prior to index date, overall and by LOT(Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest))