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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003253
Receipt No. R000003768
Scientific Title Multicenter Phase II Study of FOLFOX/XELOX and Erbitux as First Line Therapy in Patients with Wild Type KRAS/BRAF Metastatic Colorectal Cancer.
Date of disclosure of the study information 2010/02/24
Last modified on 2018/09/20

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Basic information
Public title Multicenter Phase II Study of FOLFOX/XELOX and Erbitux as First Line Therapy in Patients with Wild Type KRAS/BRAF Metastatic Colorectal Cancer.
Acronym Multicenter Phase II Study of FOLFOX/XELOX and Erbitux with Wild Type KRAS/BRAF mCRC.
Scientific Title Multicenter Phase II Study of FOLFOX/XELOX and Erbitux as First Line Therapy in Patients with Wild Type KRAS/BRAF Metastatic Colorectal Cancer.
Scientific Title:Acronym Multicenter Phase II Study of FOLFOX/XELOX and Erbitux with Wild Type KRAS/BRAF mCRC.
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 and safety of cetuximab plus FOLFOX/XELOX in patients with EGFR-detectable and KRAS/BRAF wild type metastatic colorectal carcinoma.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes Progression-free survival, Overall survival, Disease control rate, Safety profile, Dose intensity, Conversion rate of nonresectable liver metastases
to resectable

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 500mg/m2/bi-week(day1)
Oxaliplatin 85mg/m2/bi-week(day1)
l-LV 200 mg/m2/bi-week(day1)
5-FU/bolus 400mg/m2/bi-week bolus(day1)
5-FU/infusional 2400mg/m2/bi-week(day1-3)

Cetuximab 500mg/m2/bi-week(day1)
Oxaliplatin 85mg/m2/bi-week(day1)
Capecitabine 2000mg/m2/day1-7.bi-wekly
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

Not applicable
Gender Male and Female
Key inclusion criteria (1)Patients with histologically proven colorectal cancer
(2)EGFR expression is confirmed by immunohistochemical evaluation
(3)KRAS wild type in codon 12, 13, 61 and BRAF wild type in V600E
(4) Metastatic and/or recurrent disease and no prior chemotherapies.

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

(5)Age 20 years<=
(6)ECOG performance status 0-1
(7)Presence of at least one measurable lesion (according to the RECIST)
(8)Patiens have enough organ function for study treatment
(9)Life expectancy of more than 3 months
(10)Written informed consent
Key exclusion criteria (1)Severe bone marrow suppression
(2)Severe infectious disease
(3) Severe dysesthesia or sensory abnormality with functional disorder
(4) History of psychiatric disorder, central nervous system disorder or cerebrovascular accident
(5)Comorbidity or history of heart failure
(6)Comorbidity or history of interstitial lung disease or pulmonary fibrosis
(7) Radiotherapy to target lesion ( Perioperative Adjuvant Radiotherapy is eligible )
(8)History of severe allergy
(9)Pregnant or lactating women or women of childbearing potential
(10)Severe comorbidity (renal insufficiency, hepatic failure, hypertension, hypercalcemia etc)
(11)Symptomatic brain metastasis
(12)Simultaneous or metachronous double cancers
(13)Any other cases who are regarded as inadequate for study enrollment by the investigator.
Target sample size 57

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideyuki Mishima
Organization Aichi Medical University
Division name Cancer Center
Zip code
Address 1-1, Yazakokarimata, Nagakute, Aichi
TEL 0561-62-3311
Email hmishima@aichi-med-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mai Hatta
Organization Young Leaders&#39; Program (YLP), Nagoya University School of Medicine
Division name See Above
Zip code
Address 65 Tsurumai Showa-ku Nagoya
TEL 052-744-2442
Homepage URL
Email m-hatta@med.nagoya-u.ac.jp

Sponsor
Institute Epidemiological and Clinical research Information Network (ECRIN)
Institute
Department

Funding Source
Organization Epidemiological and Clinical Research Information Network (ECRIN)
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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
2010 Year 02 Month 24 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results: The response rates in the FOLFOX + Cmab (n = 37) and XELOX + Cmab (n = 25) groups were 64.9 % (24/37)
and 72.0 % (18/25), respectively. The median PFS in the FOLFOX + Cmab and XELOX + Cmab groups was 13.1 months
(95 % confidence interval [CI] 12.1-17.5) and 13.4 months (95 % CI 10.1-17.9), respectively. Neutropenia was the most
frequent grade 3/4 adverse event in both groups (33.9 %), followed by anorexia, acneiform eruption, skin fissure and
paronychia. A waterfall plot of tumor diameter showed prominent shrinkage of the tumors in 88.7 % of patients.
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 Completed
Date of protocol fixation
2010 Year 01 Month 28 Day
Date of IRB
Anticipated trial start date
2010 Year 02 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 BMC Cancer. 2015 Oct 14;15:695.

Multicenter Phase II study of FOLFOX or biweekly XELOX and Erbitux (cetuximab) as first-line therapy in patients with wild-type KRAS/BRAF metastatic colorectal cancer: The FLEET study.

Soda H, Maeda H, Hasegawa J, Takahashi T, Hazama S, Fukunaga M, Kono E, Kotaka M, Sakamoto J, Nagata N, Oba K, Mishima H.

Management information
Registered date
2010 Year 02 Month 24 Day
Last modified on
2018 Year 09 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003768

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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