Clinical trial NCT03386825: Metastatic Colorectal Cancer Patients With Long-term Response to Regorafenib
Official title: COLONG: Metastatic Colorectal Cancer Patients With Long-term Response to Regorafenib
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Neoplasms
Keywords: Metastatic Colorectal Cancer
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2017-12-29
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Belgian mCRC patients who were treated with Stivarga between the 1st of July 2015 and 31 July 2017.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Proportion of patients with a DoT to Stivarga of more than 4 months versus total study sample
timeFrame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
measure: ECOG performance status (0, 1)
timeFrame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
measure: Primary site of disease
timeFrame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
measure: Tumor resection (yes, no, unknown)
timeFrame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
measure: Specific site of metastasis
timeFrame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
measure: KRAS mutation (yes, no, unknown)
timeFrame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
measure: RAS mutation (yes, no, unknown)
timeFrame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
measure: BRAF mutation (yes, no, unknown)
timeFrame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Secondary outcomes:
measure: Start date of Stivarga treatment
timeFrame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
measure: Number of prior treatment lines for metastatic cancer larger than 3 (yes, no, unknown)
timeFrame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
measure: Reason for discontinuation of Stivarga treatment
timeFrame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
measure: Subsequent mCRC treatment
timeFrame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
measure: Last daily Stivarga dose
timeFrame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
measure: Duration of treatment (months)
timeFrame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Other outcomes:
Locations:
city: Multiple Locations
country: Belgium
facility: Belgium
Study officials:
References: