check_circleStudy Completed

Metastatic colorectal cancer

Bayer Identifier:

22124

ClinicalTrials.gov Identifier:

NCT05551039

EudraCT Number:

Not Available

EU CT Number:

Not Available
An observational study, called RegoFlex EU, to learn more about the use of Stivarga at reduced doses as recommended (flexible dosing) to treat people with metastatic colorectal cancer in real world settings in Europe

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - 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
  • - Patients with regorafenib treatment prior to January 1, 2019
    - Patients who have participated in a clinical trial

Trial summary

Enrollment Goal
300
Trial Dates
August 2022 - January 2023
Phase
N/A
Could I Receive a placebo
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locationsWhippany, 07981, United States

Primary Outcome

  • Proportion of patients initiating a flexible regorafenib dose (40, 80, or 120 mg) versus 160 mg
    date_rangeTime Frame:
    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)
  • Dose at treatment end (last prescribed regorafenib dose): 40, 80, 120, or 160 mg
    date_rangeTime Frame:
    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
    The sum of dose strength (mg) will be divided by the days on therapy in each cycle.
    date_rangeTime Frame:
    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 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)
    date_rangeTime Frame:
    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 full dose of 160 mg
    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.
    date_rangeTime Frame:
    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)
  • Number of cycles received
    date_rangeTime Frame:
    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
    The label recommended regorafenib treatment cycle is 28 days.
    date_rangeTime Frame:
    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 (DoT)
    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.
    date_rangeTime Frame:
    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 (TTD)
    Time to discontinuation: time (months) from date of initial regorafenib dose to date of discontinuation (as indicated by CRF)
    date_rangeTime Frame:
    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 with reasons for discontinuation
    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.
    date_rangeTime Frame:
    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)

Secondary Outcome

  • Descriptive summary of demographics characteristics
    Demographic characteristics includes: age, sex, index year (calendar year of regorafenib treatment initiation date), race, alive or deceased at time of data collection, primary cause of death (for deceased patients only).
    date_rangeTime Frame:
    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
    Stage of disease includes: Stage IVA; Stage IVB and Stage IVC
    date_rangeTime Frame:
    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
    ECOG scale scores are: 0, 1, 2, 3, 4 and Unknow. The higher score means worse performance status.
    date_rangeTime Frame:
    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
    Primary tumor status includes: Local recurrence; Resected and Unresected
    date_rangeTime Frame:
    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
    Number of metastatic includes: 1, 2 and ≥3
    date_rangeTime Frame:
    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
    Site of metastasis includes: Bone, Liver, Lung, Lymph node, Peritoneum and Other.
    date_rangeTime Frame:
    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
    K-RAS mutation status and N-RAS mutation status includes: Wild type, Mutated and Unknown.
    date_rangeTime Frame:
    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
    Line of therapy (LOT) for regorafenib includes: 2nd, 3rd, 4th and 5th or higher.
    date_rangeTime Frame:
    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
    Prior adjuvant treatment includes: No and Yes.
    date_rangeTime Frame:
    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
    Treatments includes: Fluorouracil, Capecitabine, Irinotecan, Leucovorin, Mitomycin, Oxaliplatin, Anti-EGFR monoclonal antibody snf Anti-VEGF monoclonal antibody.
    date_rangeTime Frame:
    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
    Pre-existing comorbidities: Asthma, Atrial fibrillation, Auto-immune disease, Cardiac dysfunction, Chronic obstructive pulmonary disease, COVID-19, Diabetes, Hepatitis C, AIDS/HIV, Human papillomavirus, Liver dysfunction, Parkinson’s, Peripheral neuropathy, Renal dysfunction, Thrombocytopenia, Venous thromboembolism, Other and None.
    date_rangeTime Frame:
    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)

Trial design

RegoFlex EU/Real World Evidence on Stivarga Flexible Dosing in Patients with Metastatic Colorectal Cancer in Europe
Trial Type
Observational
Intervention Type
Other
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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