UMIN-CTR Clinical Trial

Basic information
Public title	Translational Research of Phase II study of FOLFIRI+Ramucirumab with early recurrent colorectal cancer refractory to adjuvant chemotherapy with oxaliplatin / fluoropyrimidine (RAINCLOUD)
Acronym	RAINCLOUD-TR
Scientific Title	Translational Research of Phase II study of FOLFIRI+Ramucirumab with early recurrent colorectal cancer refractory to adjuvant chemotherapy with oxaliplatin / fluoropyrimidine (RAINCLOUD)
Scientific Title:Acronym	RAINCLOUD-TR
Region	Japan

Condition
Condition	Colorectal Cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To analyze the clinical correlation between biomarkers (both relevant or other) and clinical outcome as the patients registerd the RAINCLOUD study.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Plasma levels of VEGF-A,PlGF and VEGFR-1
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Collecting blood 12mL at the time of before RAINCLOUD protocol treatment, and PD.
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) Approved to supply the samples for this study by Institutional Review Board 2) Written informed consent
Key exclusion criteria	1) Patients who are regarded as inadequate for study enrollment by investigators 2) Patients who refuse to supply the samples
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Naotoshi Middle name Last name Sugimoto
Organization	Osaka International Cancer Institute
Division name	Medical Oncology
Zip code	537-8511
Address	3-1-69, Otemae, Chuo-ku, Osaka
TEL	06-6945-1181
Email	sugimoto-na2@mc.pref.osaka.jp

Public contact
Name of contact person	1st name Naotoshi Middle name Last name Sugimoto
Organization	Osaka International Cancer Institute
Division name	Medical Oncology
Zip code	537-8511
Address	3-1-69, Otemae, Chuo-ku, Osaka
TEL	06-6945-1181
Homepage URL
Email	sugimoto-na2@mc.pref.osaka.jp

Sponsor
Institute	MCSGO: Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
Institute
Department

Funding Source
Organization	Eli Lilly Japan K.K.
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	Osaka International Cancer Institute
Address	3-1-69, Otemae, Chuo-ku, Osaka
Tel	+81669451181
Email	rinri@opho.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	2017 Year 08 Month 15 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	Enrolling by invitation
Date of protocol fixation	2017 Year 08 Month 01 Day
Date of IRB	2017 Year 08 Month 01 Day
Anticipated trial start date	2017 Year 08 Month 16 Day
Last follow-up date	2022 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 08 Month 15 Day
Last modified on	2021 Year 09 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032831