UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040586 |
|---|---|
| Receipt number | 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 | 2024/06/27 17:14:45 |
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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
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
t.kawakami@scchr.jp
Sponsor or person
Institute
Kyushu Study group of Clinical Cancer
Institute
Department
Personal name
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
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
独立行政法人国立病院機構九州医療センター
独立行政法人国立病院機構九州がんセンター
佐賀県医療センター好生館
地方独立行政法人神戸市民病院機構 神戸市立医療センター中央市民病院
医療法人薫風会佐野病院
関西医科大学病院
独立行政法人国立病院機構名古屋医療センター
愛知県がんセンター
聖マリアンナ医科大学病院
埼玉県立がんセンター
北海道大学病院
手稲渓仁会病院
独立行政法人労働者健康安全機構釧路労災病院
国家公務員共済組合連合会斗南病院
北見赤十字病院
富山大学附属病院
恵佑会札幌病院
筑波大学附属病院
石川県立中央病院
慶應義塾大学病院
近畿大学病院
茨城県立中央病院
大阪府立急性期・総合医療センター
静岡県立静岡がんセンター
大阪医科大学附属病院
岐阜大学医学部附属病院
香川大学医学部附属病院
熊本大学病院
JCHO九州病院
土浦協同病院
札幌医科大学病院
北海道がんセンター
秋田赤十字病院
NTT東日本札幌病院
市立函館病院
日本赤十字社和歌山医療センター
社会医療法人明和会 中通総合病院
堺市立総合医療センター
公立学校共済組合九州中央病院
宮崎大学医学部附属病院
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
501
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
Completed
Date of protocol fixation
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2024 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046308
