UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000006819
Receipt number	R000008063
Scientific Title	Multicenter Phase II Study of FOLFIRI and biweekly Cetuximab combination chemotherapy as First Line Therapy in Patients with Wild Type KRAS Metastatic Colorectal Cancer. ( FIRBIC )
Date of disclosure of the study information	2011/12/01
Last modified on	2019/02/14 14:37:55

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Basic information

Public title

Multicenter Phase II Study of FOLFIRI and biweekly Cetuximab combination chemotherapy as First Line Therapy in Patients with Wild Type KRAS Metastatic Colorectal Cancer. ( FIRBIC )

Acronym

Phase II Study of FOLFIRI and biweekly Cetuximab with Wild Type KRAS mCRC. (FIRBIC)

Scientific Title

Multicenter Phase II Study of FOLFIRI and biweekly Cetuximab combination chemotherapy as First Line Therapy in Patients with Wild Type KRAS Metastatic Colorectal Cancer. ( FIRBIC )

Scientific Title:Acronym

Phase II Study of FOLFIRI and biweekly Cetuximab with Wild Type KRAS mCRC. (FIRBIC)

Region

Japan

Condition

Colorectal Cancer

Classification by specialty

Gastroenterology Hematology and clinical oncology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

YES

Objectives

Narrative objectives1

To evaluate the efficacy of FOLFIRI and biweekly Cetuximab in patients with KRAS wild type metastatic colorectal carcinoma.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Assessment

Primary outcomes

Response rate

Key secondary outcomes

Progression-free survival, Overall survival, According to part response rate, Disease control rate, Safety profile, R0 resection rate, waterfall plot analysis, Cumulative response rate (30%), Effective reduction ratio (ROC), Cytoreductive ratio and duration for the liver

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

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Cetuximab 500 mg/m2/every 2weeks (day1)
CPT-11 100 or 150 mg/m2 every 2weeks (day1)
l-LV 200 mg/m2/every 2weeks (day1)
5-FU/bolus 400 mg/m2/every 2weeks bolus (day1)
5-FU/infusional 2,400 mg/m2/every 2weeks (day 1-3)

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

(1)Histolopathologically confirmed colorectal cancer
(2) KRAS wild type in codon 12 and 13 in the primary or metastatic tumor tissue is confirmed.
(3) The case that presence or absence of genetic polymorphism of UGT1A1 *6 and UGT1A1 *28 is confirmed in peripheral blood.
(4) Unresectable metastatic and/or recurrent colorectal cancer.

Prior Oxaliplatin adjuvant therapy is allowed if it is completed at least 24 weeks before registration.

Excluded prior chemotherapy CPT-11 and/or EGFR antibody.

(5) Age: 20-75
(6)ECOG performance status 0-2

(7)Presence of at least one measurable lesion (according to the RECIST ver1.1)

(8)Patients have enough organ function for study treatment
i) WBC: >=3,000/mm3
ii) ANC: >=1,500/mm3
iii) Plt: >=100,000/mm3
iv) Hb: >=8.0g/dL
v) Total bilirubin<=upper limit of normal (ULN)*2
vi) AST(GOT) and ALT(GPT): <=100*IU/L
(<=ULN*5 in case of liver metastasis)
vii) Creatinine: <=1.5mg/dL

(9)Life expectancy of more than 3 months
(10)Written informed consent

Key exclusion criteria

(1)Severe bone marrow suppression
(2)History of severe allergy
(3) Active infection (include type B , C a hepatitis carrier)
(4)Wattery diarrhea
(5)Paralytic or mechanical bowel obstruction
(6)Massive pleural effusion or ascites
(7)Severe heart failure
(8) Uncontrolled DM
(9)Comorbidity or history of interstitial lung disease or pulmonary fibrosis
(10)Jaundice
(11) Multiple bone metastasis
(12)Simultaneous or metachronous double cancers (Carcinoma in situ is eligible).
(13)Patients who is receiving Atazanavir Sulfate
(14) Mental disorder, central nervous system disorder or severe cerebrovasculara disease
(15) Radiotherapy to target lesion (Adjuvant radiation therapy before and after the curative resection )
(16) Pregnant or lactating women or women of childbearing potential or men who are planning family
(17)Severe complications
(18)Symptomatic brain metastasis
(19) Active bleeding or blood transfusion within two weeks.
(20) Not appropriate for the study at the physician's assessment

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Norisuke Nakayama

Organization

Kanagawa Cancer Center

Division name

Gastroenterology

Zip code

Address

2-3-2, Nakao, Asahi-ku, Yokohama, 241-0815

TEL

045-520-2222

Email

norisuke@kcch.jp

Public contact

Name of contact person

1st name

Middle name

Last name Norisuke Nakayama

Organization

Kanagawa Cancer Center

Division name

Gastroenterology

Zip code

Address

2-3-2 Nakao, Asahi-ku, Yokohama, 241-0815

TEL

045-520-2222

Homepage URL

Email

norisuke@kcch.jp

Sponsor or person

Institute

Kanagawa Cancer Center

Institute

Department

Personal name

Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Other related organizations

Co-sponsor

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Address

Tel

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2011 Year 12 Month 01 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

Terminated

Date of protocol fixation

2011 Year 10 Month 17 Day

Date of IRB

Anticipated trial start date

2011 Year 12 Month 01 Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Management information

Registered date

2011 Year 12 Month 01 Day

Last modified on

2019 Year 02 Month 14 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008063

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name