Prospective observational study investigating the impact of treatment sequence using regorafenib and FTD/TPI for metastatic colorectal cancer on overall survival

Prospective observational study investigating the impact of treatment sequence using regorafenib and FTD/TPI for metastatic colorectal cancer on overall survival - OSERO study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000040586

Enrollment

500

Registered

2020-07-01

Start date

2020-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colorectal cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with histologically confirmed advanced unresectable colorectal cancer (CRC) or metastatic CRC (mCRC). 2) Patients with unresectable CRC or mCRC who are intolerant or refractory to fluoropyrimidine, oxaliplatin, irinotecan, anti-angiogenesis therapy, and anti-epithelial growth factor (EGFR) therapy (if RAS wild type). 3) Aged >=20 years 4) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 5) Patient who are planned to receive sequential treatment with regorafenib-FTD/TPI. 6) Patients must have no severe dysfunction of major organs(bone marrow, liver, kidneys, heart, lungs, etc.). In addition,the patient's laboratory results from up to 14 days prior to enrollment should meet the following criteria: Neutrophil count >=1,200 cells/mm^3 Platelet count >=75,000 cells/mm^3 Total bilirubin <=1.5 mg/dL AST (GOT)<=100 IU/L or <=200 IU/L in patients with liver metastases ALT (GPT)<=100 IU/L or <=200 IU/L in patients with liver metastases Creatinine <1.2 mg/dL Protein urea 1+ or urine protein creatinine ratio (UPCR) < 2.0 7) Written informed consent obtained from every patient before enrollment in the study.

Exclusion criteria

Exclusion criteria: 1) Prior treatment with regorafenib or FTD/TPI 2) Patients with active multiple cancers 3) Patients who have symptomatic brain metastases. 4) Patients with diabetes mellitus, hyper tension, angina unstable, or symptomatic congestive heart failure (NYHA III/IV) that cannot be controlled adequately with medication. 5) Patients whom a lead investigator or primary physician deems are not appropriate for this study.

Design outcomes

Primary

Measure	Time frame
Overall survival (OS) of sequential treatment with regorafenib-FTD/TPI	—

Countries

Japan

Contacts

Public ContactTakeshi Kawakami

Shizuoka Cancer Center Department of Gastrointestinal Oncology

t.kawakami@scchr.jp055-989-5222

Outcome results