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NCT Number: NCT03829852

Regorafenib in Taiwan Metastatic Colorectal Cancer (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.

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Key information

Conditions

Metastatic Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Taipei Veterans General Hospital

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

regorafenib

Drug

Treatment was performed based on physician's discretion

Primary outcomes

  1. Effectiveness of regorafenib use in routine clinical practice setting, assessed by overall survival (OS)

    Time frame: through study completion, estimated 2 years

    months

  2. Effectiveness of regorafenib use in routine clinical practice setting, assessed by progression free survival (PFS)

    Time frame: through study completion, estimated 2 years

    months

  3. Effectiveness of regorafenib use in routine clinical practice setting, assessed by time to progression (TTP)

    Time frame: through study completion, estimated 2 years

    months

  4. Effectiveness of regorafenib use in routine clinical practice setting, assessed by tumor response

    Time frame: through study completion, estimated 2 years

    percentage

Secondary outcomes

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

    Time frame: through study completion, estimated 2 years

    percentage

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

    Time frame: through study completion, estimated 2 years

    percentage

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

    Time frame: through study completion, estimated 2 years

    percentage

  4. 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)

    Time frame: through study completion, estimated 2 years

    percentage

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

    Time frame: through study completion, estimated 2 years

    months

  6. Eligibility of subsequent therapies and the outcome, assessed by PFS

    Time frame: through study completion, estimated 2 years

    months

Other outcomes

  1. 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

    Time frame: through study completion, estimated 2 years

    correlation

  2. 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

    Time frame: through study completion, estimated 2 years

    correlation

  3. 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

    Time frame: through study completion, estimated 2 years

    correlation

  4. 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

    Time frame: through study completion, estimated 2 years

    correlation

Sponsors and collaborators

Lead sponsor

Taipei Veterans General Hospital, Taiwan

Other Gov

Collaborators

  • Chang Gung Memorial Hospital
  • Koo Foundation Sun Yat-Sen Cancer Center

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 4, 2019
Registry last updated
Jul 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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