UMIN-CTR Clinical Trial

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

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

Objectives
Narrative objectives1	To examine the efficacy of FOLFIRI in combination with ramucirumab for the recurrent colorectal cancer refractory to adjuvant chemotherapy with oxaliplatin / fluoropyrimidine.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Progression-Free Survival (PFS)
Key secondary outcomes	Overall Survival (OS), Time to treatment failure (TTF), Response Rate (RR), Disease Control Rate (DCR), Adverse Events

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	FOLFIRI+Ramucirumab (5-FU(bolus): 400mg/m2 on day1, 5-FU(ci): 2,400mg/m2 on day1-3 (46hr), l-LV: 200mg/m2 on day1, CPT-11: 180*mg/m2 on day1, Ramucirumab: 8mg/kg on day1) *Allow dose level -1 (150mg/m2)
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) Histologically or cytologically confirmed colorectal cancer (is not included appendiceal cancer) 2) Confirmed recurrent colorectal cancer 3) Has a history of receiving oxaliplatin and fluoropyrimidine as adjuvant chemotherapy and corresponded to the one of the following criterion, a) experienced radiographic recurrence during chemotherapy b) experienced radiographic recurrence within 12 months after discontinuation of chemotherapy due to the adverse events c) experienced radiographic recurrence within 12 months after the completion of scheduled chemotherapy d) doctor judged the patients were intolerant to oxaliplatin 4) Has measureable or nonmeasurable disease based on RECIST v 1.1 5) The patient who is expected to survive more than 3 months after the initiation of administration. 6) Has resolution to Grade=<1, per the NCI-CTCAE v. 4.03, of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy, with the exception of peripheral neuropathy, which must have resolved to Grade =<2 and except where otherwise noted in the eligibility criteria. 7) Has an ECOG performance status of 0 or 1. 8) Has adequate hematologic function 9) Has adequate coagulation function 10) They are clinically stable, asymptomatic, and adequately treated with anticoagulation in the opinion of the investigator 11) Has adequate hepatic function 12) Has adequate renal function 13) Urinary protein is less than 1+ on dipstick or routine urinalysis 14) The patient has had disease notification and is able to provide signed informed consent. 15) >=20 years of age. 16) Eligible patients of reproductive potential (both sexes) must agree to useadequate contraception methods (hormonal or barrier methods) during thestudy period and at least 12 weeks after the last dose of study treatment or longer if required per local regulations.
Key exclusion criteria	1) Has simultaneous or metachronous 2) Has a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders 3) Has an uncontrolled intercurrent illness 4) Has experienced any arterial thrombotic or arterial thromboembolic events 5) Receiving chronic antiplatelet therapy, including aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), dipyridamole or clopidogrel, or similar agents. Once-daily aspirin use (maximum dose 325 mg/day) is permitted 6) Has known (currently or in the past) leptomeningeal disease or brain metastases or uncontrolled spinal cord compression 7) Has an ongoing or active infection requiring parenteral antibiotic, antifungal, or antiviral therapy 8) Either of HIV-1 antibody, HIV-2 antibody or HBs antigen is positive 9) The patient who is HBs antibody or HBc antibody positive and HBV-DNA positive 10) Has received a prior autologous or allogeneic organ or transplantation 11) Has undergone major surgery within 28 days prior to randomization or subcutaneous venous access device placement within 7 days prior to randomization 12) Has had a serious nonhealing wound, ulcer, or bone fracture within 28 days prior to randomization 13) Has an elective or planned major surgery to be performed during the course of the trial 14) Has an acute or subacute bowel obstruction or history of chronic diarrhea which is considered clinically significant in the opinion of the investigator 15) Has experienced a Grade 3 or higher bleeding event within 3 months prior to randomization 16) Has either peptic ulcer disease associated with a bleeding event, or known active diverticulitis 17) Has a known history or clinical evidence of Gilberts Syndrome, or is known to have any of the following genotypes: UGT1A1*6/*6, UGT1A1*6/*28, UGT1A1*28/*28 18) The patient desires to have children. 19) The patient whose participation is in the trial is inappropriate by the doctor
Target sample size	48

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 KK
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	06-6945-1181
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=R000032829