Regorafenib in Taiwan Metastatic Colorectal Cancer (mCRC) Patients

NCT03829852 | Completed

• 1 other identifier: 2018-12-013BC
• Study Type: observational
• Target: 716
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Safety of regorafenib use in routine clinical practice setting, assessed by incidence of adverse events (AEs)

  through study completion, estimated 2 years

• Safety of regorafenib use in routine clinical practice setting, assessed by initial dose

  through study completion, estimated 2 years

• Safety of regorafenib use in routine clinical practice setting, assessed by dose intensity during the first 2 cycles

  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)

  through study completion, estimated 2 years

• Eligibility of subsequent therapies and the outcome, assessed by treatment duration

  through study completion, estimated 2 years

Other Outcomes (4)

• 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

  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

  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

  through study completion, estimated 2 years

Interventions

Regorafenib DRUG

Treatment was performed based on physician's discretion

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• \<=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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead
• Chang Gung Memorial Hospital: collaborator
• Koo Foundation Sun Yat-Sen Cancer Center: collaborator

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 34321583 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

regorafenib

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Hao-Wei Teng, MD, PhD

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2019
• First Posted: February 4, 2019
• Study Start: February 11, 2019
• Primary Completion: December 8, 2020
• Study Completion: December 8, 2020
• Last Updated: July 23, 2021

Record last verified: 2021-07

Locations

TW (1)