UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter Phase II Study of FOLFOX/XELOX and Erbitux as First Line Therapy in Patients with Wild Type KRAS/BRAF Metastatic Colorectal Cancer.
Title of the study (Brief title)	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	Hideyuki Mishima
Organization	Aichi Medical University
Division name	Cancer Center
Address	1-1, Yazakokarimata, Nagakute, Aichi
TEL	0561-62-3311
Email	hmishima@aichi-med-u.ac.jp

Public contact
Name of contact person	Mai Hatta
Organization	Young Leaders' Program (YLP), Nagoya University School of Medicine
Division name	See Above
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 01 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
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.
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