Clinical trial NCT03829852: Regorafenib in Taiwan Metastatic Colorectal Cancer (mCRC) Patients
Official title: Investigate the Real-life Treatment Outcome of Regorafenib in Treating mCRC Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Colorectal Cancer
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
Collaborators: name: Chang Gung Memorial Hospital
name: Koo Foundation Sun Yat-Sen Cancer Center
First posted: 2019-02-04
Enrollment: 716
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Effectiveness of regorafenib use in routine clinical practice setting, assessed by overall survival (OS)
timeFrame: through study completion, estimated 2 years
measure: Effectiveness of regorafenib use in routine clinical practice setting, assessed by progression free survival (PFS)
timeFrame: through study completion, estimated 2 years
measure: Effectiveness of regorafenib use in routine clinical practice setting, assessed by time to progression (TTP)
timeFrame: through study completion, estimated 2 years
measure: Effectiveness of regorafenib use in routine clinical practice setting, assessed by tumor response
timeFrame: through study completion, estimated 2 years
Secondary outcomes:
measure: Safety of regorafenib use in routine clinical practice setting, assessed by incidence of adverse events (AEs)
timeFrame: through study completion, estimated 2 years
measure: Safety of regorafenib use in routine clinical practice setting, assessed by initial dose
timeFrame: through study completion, estimated 2 years
measure: Safety of regorafenib use in routine clinical practice setting, assessed by dose intensity during the first 2 cycles
timeFrame: through study completion, estimated 2 years
measure: 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)
timeFrame: through study completion, estimated 2 years
measure: Eligibility of subsequent therapies and the outcome, assessed by treatment duration
timeFrame: through study completion, estimated 2 years
measure: Eligibility of subsequent therapies and the outcome, assessed by PFS
timeFrame: through study completion, estimated 2 years
Other outcomes:
measure: 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
timeFrame: through study completion, estimated 2 years
measure: 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
timeFrame: through study completion, estimated 2 years
measure: 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
timeFrame: through study completion, estimated 2 years
measure: 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
timeFrame: through study completion, estimated 2 years
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Hao-Wei Teng, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.