Metastatic Colorectal Cancer Patients With Long-term Response to Regorafenib (COLONG)

COLONG: Metastatic Colorectal Cancer Patients With Long-term Response to Regorafenib

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Neoplasms
• Intervention / Treatment: Drug: Regorafenib (Stivarga, BAY73-4506)

• Study Type: Observational
• Enrollment (Actual): 76

Contacts and Locations

Study Locations

• Belgium
  • Multiple Locations, Belgium
    • Belgium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Regorafenib_DoT<4 months; DoT < 4 months	Drug: Regorafenib (Stivarga, BAY73-4506); Antineoplastic agents, protein kinase inhibitor (L01XE21)
Regorafenib_4 months ≤ DoT < 12 months; 4 months ≤ DoT < 12 months	Drug: Regorafenib (Stivarga, BAY73-4506); Antineoplastic agents, protein kinase inhibitor (L01XE21)
Regorafenib_DoT ≥ 12 months; DoT ≥ 12 months	Drug: Regorafenib (Stivarga, BAY73-4506); Antineoplastic agents, protein kinase inhibitor (L01XE21)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	progression - symptomatic, Progression - radiological, Progression - radiological + symptomatic, Progression - unknown, Intolerability, Death, other, unknown, not applicable	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	Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Last daily Stivarga dose	80 mg, 120 mg, 160 mg, other, unknown	Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Duration of treatment (months)		Retrospective chart review from 1-Jul-2015 to 1-Dec-2017

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2018
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: December 22, 2017
• First Submitted That Met QC Criteria: December 22, 2017
• First Posted (Actual): December 29, 2017

Study Record Updates

• Last Update Posted (Actual): May 15, 2018
• Last Update Submitted That Met QC Criteria: May 14, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Metastatic Colorectal Cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 19577

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No