UMIN-CTR Clinical Trial

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

Colorectal Cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

Eli Lilly Japan KK

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Osaka International Cancer Institute

Address

3-1-69, Otemae, Chuo-ku, Osaka

Tel

06-6945-1181

Email

rinri@opho.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

08

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2017

Year

08

Month

15

Day

Last modified on

2021

Year

09

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032829