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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000006819
Receipt No. 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

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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
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
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
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
URL(English) https://upload.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


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