Regorafenib in Taiwan Metastatic Colorectal Cancer (mCRC) Patients

Metastatic Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03829852
• Other study ID #: 2018-12-013BC
• Status: Completed
• Start date: February 11, 2019
• Est. completion date: December 8, 2020

Study information

• Verified date: July 2021
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 716
• Est. completion date: December 8, 2020
• Est. primary completion date: December 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• Regorafenib
Treatment was performed based on physician's discretion

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (3)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan	Chang Gung Memorial Hospital, Koo Foundation Sun Yat-Sen Cancer Center

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	Effectiveness of regorafenib use in routine clinical practice setting, assessed by overall survival (OS)	months	through study completion, estimated 2 years
Primary	Effectiveness of regorafenib use in routine clinical practice setting, assessed by progression free survival (PFS)	months	through study completion, estimated 2 years
Primary	Effectiveness of regorafenib use in routine clinical practice setting, assessed by time to progression (TTP)	months	through study completion, estimated 2 years
Primary	Effectiveness of regorafenib use in routine clinical practice setting, assessed by tumor response	percentage	through study completion, estimated 2 years
Secondary	Safety of regorafenib use in routine clinical practice setting, assessed by incidence of adverse events (AEs)	percentage	through study completion, estimated 2 years
Secondary	Safety of regorafenib use in routine clinical practice setting, assessed by initial dose	percentage	through study completion, estimated 2 years
Secondary	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
Secondary	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
Secondary	Eligibility of subsequent therapies and the outcome, assessed by treatment duration	months	through study completion, estimated 2 years
Secondary	Eligibility of subsequent therapies and the outcome, assessed by PFS	months	through study completion, estimated 2 years