check_circleStudy Completed

Colorectal Neoplasms

Bayer Identifier:

19577

ClinicalTrials.gov Identifier:

NCT03386825

EudraCT Number:

Not Available

EU CT Number:

Not Available
Metastatic Colorectal cancer patients with Long-term response to regorafenib

Trial purpose

The aim of this local NIS(Non-Interventional Study) is to determine the proportion of Belgian patients with a duration of treatment(DoT) to Stivarga of 4 months or more in relation to the total population of Belgian metastatic colorectal cancer(mCRC) patients who were treated with Stivarga between the 1st of July 2015 and 31 July 2017. In addition, this study aims to describe the clinical characteristics of Belgian patients with a short- or long-term DoT to Stivarga.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - Male or female patients ≥ 18 years of age.
    - Patients who suffer from mCRC and who started treatment with Stivarga between the 1st of July 2015 and 31 July 2017.
    - Patients who already received alternative treatment options before Stivarga for the treatment of mCRC or who were not eligible for other treatment options.
    - Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 1 at start of Stivarga treatment.
    - Sufficient kidney, liver and bone marrow function start of Stivarga treatment.
    - Life expectancy ≥ 3 months at start of Stivarga treatment


  • - Patients participating in an investigational program/clinical trial with interventions outside of routine clinical practice during the observational period.

Trial summary

Enrollment Goal
76
Trial Dates
February 2018 - April 2018
Phase
Phase 4
Could I Receive a placebo
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Belgiummany locations, Belgium

Primary Outcome

  • Proportion of patients with a DoT to Stivarga of more than 4 months versus total study sample
    date_rangeTime Frame:
    Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
  • ECOG performance status (0, 1)
    ECOG: Eastern Cooperative Oncology Group
    date_rangeTime Frame:
    Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
  • Primary site of disease
    Rectum, Left-sided colon, Right-sided colon, Colon and rectum, Transverse, Unknown (in colon)
    date_rangeTime Frame:
    Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
  • Tumor resection (yes, no, unknown)
    date_rangeTime Frame:
    Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
  • Specific site of metastasis
    Lung, Liver, Bone, Extraregional nodes, Peritoneum, Multiple, Unknown
    date_rangeTime Frame:
    Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
  • KRAS mutation (yes, no, unknown)
    date_rangeTime Frame:
    Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
  • RAS mutation (yes, no, unknown)
    date_rangeTime Frame:
    Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
  • BRAF mutation (yes, no, unknown)
    date_rangeTime Frame:
    Retrospective chart review from 1-Jul-2015 to 1-Dec-2017

Secondary Outcome

  • Start date of Stivarga treatment
    date_rangeTime Frame:
    Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
  • Number of prior treatment lines for metastatic cancer larger than 3 (yes, no, unknown)
    date_rangeTime Frame:
    Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
  • Reason for discontinuation of Stivarga treatment
    progression – symptomatic, Progression – radiological, Progression - radiological + symptomatic, Progression – unknown, Intolerability, Death, other, unknown, not applicable
    date_rangeTime Frame:
    Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
  • Subsequent mCRC treatment
    Chemotherapy IV, Chemotherapy oral, Biologic therapy, Chemotherapy + biologic therapy, BSC, Other, Unknown, Not applicable
    date_rangeTime Frame:
    Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
  • Last daily Stivarga dose
    80 mg, 120 mg, 160 mg, other, unknown
    date_rangeTime Frame:
    Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
  • Duration of treatment (months)
    date_rangeTime Frame:
    Retrospective chart review from 1-Jul-2015 to 1-Dec-2017

Trial design

COLONG: Metastatic Colorectal cancer patients with Long-term response to regorafenib
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A