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