Regorafenib in Taiwan Metastatic Colorectal Cancer (mCRC) Patients

Completed

• Conditions: Metastatic Colorectal Cancer

• Registration Number: NCT03829852
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-19
• Study First Submitted QC: 2019-02-01
• Study First Posted: 2019-02-04
• Study Start: 2019-02-11
• Primary Completion: 2020-12-08
• Study Completion: 2020-12-08
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-21
• Last Update Posted: 2021-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 716

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Safety of regorafenib use in routine clinical practice setting, assessed by incidence of adverse events (AEs)	through study completion, estimated 2 years	percentage
Safety of regorafenib use in routine clinical practice setting, assessed by initial dose	through study completion, estimated 2 years	percentage
Safety of regorafenib use in routine clinical practice setting, assessed by dose intensity during the first 2 cycles	through study completion, estimated 2 years	percentage
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)	through study completion, estimated 2 years	percentage
Eligibility of subsequent therapies and the outcome, assessed by treatment duration	through study completion, estimated 2 years	months
Eligibility of subsequent therapies and the outcome, assessed by PFS	through study completion, estimated 2 years	months

Trial Locations

Locations (1)

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan