UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038508 |
|---|---|
| Receipt number | R000041515 |
| Scientific Title | A prospective observational study of biomarkers for Second-line FOLFIRI plus Aflibercept treatment in patients with metastatic colorectal cancer comparing to FOLFIRI plus beVacizumab: an Exploratory biomarker study. |
| Date of disclosure of the study information | 2019/11/06 |
| Last modified on | 2024/12/10 13:23:56 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A prospective observational study of biomarkers for Second-line FOLFIRI plus Aflibercept treatment in patients with metastatic colorectal cancer comparing to FOLFIRI plus beVacizumab: an Exploratory biomarker study.
Acronym
SAVE Trial
Scientific Title
A prospective observational study of biomarkers for Second-line FOLFIRI plus Aflibercept treatment in patients with metastatic colorectal cancer comparing to FOLFIRI plus beVacizumab: an Exploratory biomarker study.
Scientific Title:Acronym
SAVE Trial
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Prospective cohort study to evaluate the relations between the expression of TAM and effect of FOLFIRI + aflibercept as second line treatment in patients with anti-VEGF naive RAS wild-type metastatic and/or recurrent colorectal cancer.
Basic objectives2
Others
Basic objectives -Others
safety and efficacy in FOLFIRI + aflibercept
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Assessment
Primary outcomes
Overall response rate of FOLFIRI + aflibercept in patients with TAM-positive colorectal cancer.
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
Unresectable advanced and/or recurrent colorectal cancer with pathological diagnosis.
RAS mutation status has been veryfied and was wild type in the primary or metastatic tumor.
In the previous treatment, CPT-11, bevacizumab and aflibercept has not been used.
There is at least one measurable lesion.
PS 0-2
Key exclusion criteria
Having an infection which needs systemic treatment
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Junichi |
| Middle name | |
| Last name | Matsubara |
Organization
Kyoto University Hospital
Division name
Therapeutic oncology
Zip code
606-8507
Address
54 Kawaharcho, Shogoin, Sakyo-ku, Kyoto
TEL
075-751-3518
jmatsuba@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Junichi |
| Middle name | |
| Last name | Matsubara |
Organization
Kyoto University Hospital
Division name
Therapeutic oncology
Zip code
606-8507
Address
54 Kawaharcho, Shogoin, Sakyo-ku, Kyoto
TEL
075-751-3518
Homepage URL
jmatsuba@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Takeda Science Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Hospital
Address
54 Kawaharcho, Shogoin, Sakyo-ku, Kyoto
Tel
075-751-3518
jmatsuba@kuhp.kyoto-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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 11 | Month | 06 | 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
Completed
Date of protocol fixation
| 2019 | Year | 11 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 09 | Day |
Date analysis concluded
Other
Other related information
In this observational study, we confirm the safty and efficacy of FOLFIRI + aflivercept against advanced and/or recurrent cancer at the Kyoto University Hospital and Kyoto Min-iren Chuo Hospital.
Management information
Registered date
| 2019 | Year | 11 | Month | 06 | Day |
Last modified on
| 2024 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041515
