Regorafenib in Taiwan Metastatic Colorectal Cancer (mCRC) Patients

Investigate the Real-life Treatment Outcome of Regorafenib in Treating mCRC Patients

Regorafenib is currently the standard of care for refractory mCRC patients. Pivotal studies of regorafenib have proven the efficacy and safety, with a 28-day cycle (21 days on, 7 days off) and 160 mg dose given once daily.

In the clinic, patients often have some complicated condition. This study aims to perform retrospective medical chart review of mCRC patients who received regorafenib treatment in two medical centers in Taiwan to examine treatment effectiveness in the routine clinical practice setting.

Study Overview

• Status: Completed
• Conditions: Metastatic Colorectal Cancer
• Intervention / Treatment: Drug: Regorafenib

• Study Type: Observational
• Enrollment (Actual): 716

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Taipei Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

mCRC patients who received regorafenib treatment in Taipei Veterans General Hospital and Chang Gung Memorial Hospital Linkou, Taiwan

Description

Inclusion Criteria:

• mCRC patients who received at least one dose of regorafenib treatment

Exclusion Criteria:

• <=20 y/o
• Patients who did not receive regorafenib treatment will be excluded from the analysis
• Patients with incomplete medical records that are deemed ineligible for analysis by investigator

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of regorafenib use in routine clinical practice setting, assessed by overall survival (OS)	months	through study completion, estimated 2 years
Effectiveness of regorafenib use in routine clinical practice setting, assessed by progression free survival (PFS)	months	through study completion, estimated 2 years
Effectiveness of regorafenib use in routine clinical practice setting, assessed by time to progression (TTP)	months	through study completion, estimated 2 years
Effectiveness of regorafenib use in routine clinical practice setting, assessed by tumor response	percentage	through study completion, estimated 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of regorafenib use in routine clinical practice setting, assessed by incidence of adverse events (AEs)	percentage	through study completion, estimated 2 years
Safety of regorafenib use in routine clinical practice setting, assessed by initial dose	percentage	through study completion, estimated 2 years
Safety of regorafenib use in routine clinical practice setting, assessed by dose intensity during the first 2 cycles	percentage	through study completion, estimated 2 years
Eligibility of subsequent therapies and the outcome, assessed by type of treatment (anti-epithelial growth factor receptor [EGFR], anti-vascular endothelial growth factor [VEGF], and/or chemotherapy agents)	percentage	through study completion, estimated 2 years
Eligibility of subsequent therapies and the outcome, assessed by treatment duration	months	through study completion, estimated 2 years
Eligibility of subsequent therapies and the outcome, assessed by PFS	months	through study completion, estimated 2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory outcome:Clinical markers/ biomarkers as the potential predictive factor for regorafenib treatment outcome in overall cohort and long-term responders, assessed by patient characteristics	correlation	through study completion, estimated 2 years
Exploratory outcome:Clinical markers/ biomarkers as the potential predictive factor for regorafenib treatment outcome in overall cohort and long-term responders, assessed by changes in carcinoembryonic antigen (CEA) levels	correlation	through study completion, estimated 2 years
Exploratory outcome:Clinical markers/ biomarkers as the potential predictive factor for regorafenib treatment outcome in overall cohort and long-term responders, assessed by changes in carbohydrate antigen (CA19-9) levels	correlation	through study completion, estimated 2 years
Exploratory outcome: Image pattern as the potential predictive factor for regorafenib treatment outcome in overall cohort and long-term responders, assessed by changes in image patterns	correlation	through study completion, estimated 2 years

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan
• Collaborators: Chang Gung Memorial Hospital; Koo Foundation Sun Yat-Sen Cancer Center
• Investigators: Principal Investigator: Hao-Wei Teng, MD, PhD, Taipei Veterans General Hospital, Taiwan

Publications and helpful links

General Publications

• Hsu HC, Huang KC, Chen WS, Jiang JK, Yang SH, Wang HS, Chang SC, Lan YT, Lin CC, Lin HH, Huang SC, Cheng HH, Yang TS, Chen CC, Chao Y, Teng HW. Preference criteria for regorafenib in treating refractory metastatic colorectal cancer are the small tumor burden, slow growth and poor/scanty spread. Sci Rep. 2021 Jul 28;11(1):15370. doi: 10.1038/s41598-021-94968-x.

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2019
• Primary Completion (Actual): December 8, 2020
• Study Completion (Actual): December 8, 2020

Study Registration Dates

• First Submitted: January 19, 2019
• First Submitted That Met QC Criteria: February 1, 2019
• First Posted (Actual): February 4, 2019

Study Record Updates

• Last Update Posted (Actual): July 23, 2021
• Last Update Submitted That Met QC Criteria: July 21, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• 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: 2018-12-013BC

Drug and device information, study documents

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