UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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 )
Title of the study (Brief title)	Phase II Study of FOLFIRI and biweekly Cetuximab with Wild Type KRAS mCRC. (FIRBIC)
Region	Japan

Condition
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	1
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	45

Research contact person
Name of lead principal investigator	Norisuke Nakayama
Organization	Kanagawa Cancer Center
Division name	Gastroenterology
Address	2-3-2, Nakao, Asahi-ku, Yokohama, 241-0815
TEL	045-520-2222
Email	norisuke@kcch.jp

Public contact
Name of contact person	Norisuke Nakayama
Organization	Kanagawa Cancer Center
Division name	Gastroenterology
Address	2-3-2 Nakao, Asahi-ku, Yokohama, 241-0815
TEL	045-520-2222
Homepage URL
Email	norisuke@kcch.jp

Sponsor
Institute	Kanagawa Cancer Center
Institute
Department

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)

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	2011 Year 12 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2011 Year 10 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008063