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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040586
Receipt No. R000046308
Scientific Title Prospective observational study investigating the impact of treatment sequence using regorafenib and FTD/TPI for metastatic colorectal cancer on overall survival
Date of disclosure of the study information 2020/07/01
Last modified on 2020/05/29

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Basic information
Public title Prospective observational study investigating the impact of treatment sequence using regorafenib and FTD/TPI for metastatic colorectal cancer on overall survival
Acronym OSERO study
Scientific Title Prospective observational study investigating the impact of treatment sequence using regorafenib and FTD/TPI for metastatic colorectal cancer on overall survival
Scientific Title:Acronym OSERO study
Region
Japan

Condition
Condition colorectal cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study aims to clarify the efficacy of sequential treatment with regorafenib-trifluridine/tipiracil (FTD/TPI) as later line treatment for metastatic colorectal cancer (mCRC). We prospectively enroll mCRC patients who are planned to receive regorafenib or FTD/TPI to investigate the efficacy and safety of sequential treatment with regorafenib-FTD/TPI, and those of regorafenib and FTD/TPI monotherapy in later line.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall survival (OS) of sequential treatment with regorafenib-FTD/TPI
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key 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.
Key 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.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Eiji
Middle name
Last name Oki
Organization Graduate School of Medical Sciences, Kyushu University
Division name Department of Surgery and Science
Zip code 812-8582
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
TEL 092-642-5466
Email okieiji@surg2.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name Takeshi
Middle name
Last name Kawakami
Organization Shizuoka Cancer Center
Division name Department of Gastrointestinal Oncology
Zip code 411-8777
Address 1007 Shimonagakubo, Nagaizumicho, Suntougun, Shizuoka, Japan
TEL 055-989-5222
Homepage URL
Email t.kawakami@scchr.jp

Sponsor
Institute Kyushu Study group of Clinical Cancer
Institute
Department

Funding Source
Organization Bayer Yakuhin, Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kyushu University Hospital Clinical Trial Ethics Review Committee
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
Tel 092-641-1151
Email byssien@jimu.kyushu-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 九州大学病院(福岡県)

Other administrative information
Date of disclosure of the study information
2020 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2020 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2020 Year 07 Month 01 Day
Last follow-up date
2022 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Transition rate of subsequent line of each 3rd line treatment
Overall survival, progression-free survival, time to treatment failure, survival after progression, best overall survival, disease control rate of each treatment regimen at each treatment line
Safety of each treatment regimen at each treatment line
Drug exposure (initial dose and dose modification) of each treatment regimen at each treatment line

Management information
Registered date
2020 Year 05 Month 29 Day
Last modified on
2020 Year 05 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046308

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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