Metastatic Colorectal Cancer Patients With Long-term Response to Regorafenib

Colorectal Neoplasms Clinical Trial

— COLONG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03386825
• Other study ID #: 19577
• Status: Completed
• Start date: January 31, 2018
• Est. completion date: May 1, 2018

Study information

• Verified date: May 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: May 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Drug:
• Regorafenib (Stivarga, BAY73-4506)
Antineoplastic agents, protein kinase inhibitor (L01XE21)

Locations

Country	Name	City	State
Belgium	Belgium	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	ECOG performance status (0, 1)	ECOG: Eastern Cooperative Oncology Group	Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Primary	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
Primary	Tumor resection (yes, no, unknown)		Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Primary	Specific site of metastasis	Lung, Liver, Bone, Extraregional nodes, Peritoneum, Multiple, Unknown	Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Primary	KRAS mutation (yes, no, unknown)		Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Primary	RAS mutation (yes, no, unknown)		Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Primary	BRAF mutation (yes, no, unknown)		Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Secondary	Start date of Stivarga treatment		Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Secondary	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
Secondary	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
Secondary	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
Secondary	Last daily Stivarga dose	80 mg, 120 mg, 160 mg, other, unknown	Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Secondary	Duration of treatment (months)		Retrospective chart review from 1-Jul-2015 to 1-Dec-2017