NCT03386825

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 29, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

January 31, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

May 15, 2018

Status Verified

May 1, 2018

Enrollment Period

3 months

First QC Date

December 22, 2017

Last Update Submit

May 14, 2018

Conditions

Colorectal Neoplasms

Keywords

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (8)

  • Proportion of patients with a DoT to Stivarga of more than 4 months versus total study sample

    Retrospective chart review from 1-Jul-2015 to 1-Dec-2017

  • ECOG performance status (0, 1)

    ECOG: Eastern Cooperative Oncology Group

    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)

    Retrospective chart review from 1-Jul-2015 to 1-Dec-2017

  • Tumor resection (yes, no, unknown)

    Retrospective chart review from 1-Jul-2015 to 1-Dec-2017

  • Specific site of metastasis

    Lung, Liver, Bone, Extraregional nodes, Peritoneum, Multiple, Unknown

    Retrospective chart review from 1-Jul-2015 to 1-Dec-2017

  • KRAS mutation (yes, no, unknown)

    Retrospective chart review from 1-Jul-2015 to 1-Dec-2017

  • RAS mutation (yes, no, unknown)

    Retrospective chart review from 1-Jul-2015 to 1-Dec-2017

  • BRAF mutation (yes, no, unknown)

    Retrospective chart review from 1-Jul-2015 to 1-Dec-2017

Secondary Outcomes (6)

  • Start date of Stivarga treatment

    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)

    Retrospective chart review from 1-Jul-2015 to 1-Dec-2017

  • Reason for discontinuation of Stivarga treatment

    Retrospective chart review from 1-Jul-2015 to 1-Dec-2017

  • Subsequent mCRC treatment

    Retrospective chart review from 1-Jul-2015 to 1-Dec-2017

  • Last daily Stivarga dose

    Retrospective chart review from 1-Jul-2015 to 1-Dec-2017

  • +1 more secondary outcomes

Study Arms (3)

Regorafenib_DoT<4 months

DoT \< 4 months

Drug: Regorafenib (Stivarga, BAY73-4506)

Regorafenib_4 months ≤ DoT < 12 months

4 months ≤ DoT \< 12 months

Drug: Regorafenib (Stivarga, BAY73-4506)

Regorafenib_DoT ≥ 12 months

DoT ≥ 12 months

Drug: Regorafenib (Stivarga, BAY73-4506)

Interventions

Regorafenib (Stivarga, BAY73-4506)DRUG

Antineoplastic agents, protein kinase inhibitor (L01XE21)

Regorafenib_4 months ≤ DoT < 12 monthsRegorafenib_DoT ≥ 12 monthsRegorafenib_DoT<4 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Belgian mCRC patients who were treated with Stivarga between the 1st of July 2015 and 31 July 2017.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Belgium

Multiple Locations, Belgium

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

regorafenib

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2017

First Posted

December 29, 2017

Study Start

January 31, 2018

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

May 15, 2018

Record last verified: 2018-05

Locations

BE(1)