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 2019/11/06 20:25:21

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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

Email

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


Email

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

Email

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

Preinitiation

Date of protocol fixation

2019 Year 11 Month 10 Day

Date of IRB


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


Date trial data considered complete


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

2019 Year 11 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041515


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name