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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007195
Receipt No. R000008473
Scientific Title Phase II Study of XELOX and Cetuximab as First Line Therapy in Patients with Wild Type KRAS Metastatic Colorectal Cancer
Date of disclosure of the study information 2012/02/01
Last modified on 2018/09/20

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Basic information
Public title Phase II Study of XELOX and Cetuximab as First Line Therapy in Patients with Wild Type KRAS Metastatic Colorectal Cancer
Acronym FLEET2 study
Scientific Title Phase II Study of XELOX and Cetuximab as First Line Therapy in Patients with Wild Type KRAS Metastatic Colorectal Cancer
Scientific Title:Acronym FLEET2 study
Region
Japan

Condition
Condition Metastatic colorectal cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of XELOX+Cetuximab as first line treatment in metastatic colorectal cancer with EGFR-detectable and KRAS wild type
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 Overall Survival, Progression Free Survival, Safety, Disease Control Rate, Dose Intensity, Surgery rate

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 Capecitabine+oxaliplatin(XELOX)+Cetuximab
Cetuximab loading dose 400mg/m2, 250mg/m2/week or 500mg/m2/2weeks
Capecitabine 2000mg/m2(day1-7)/2weeks
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 histologicaly proven colorectal cancer
(2) Metastatic colorectal cancer with EGFR
(3) KRAS wild type in codon 12, 13
(4) No prior chemotherapy
(5) Age over 20 years
(6) ECOG Performance Status (PS) 0-1
(7) Presence of metastatic lesion(RECIST Ver. 1.1)
(8) Patients have enough organ function for study treatment
(9) Life expectancy of more than 3 months
(10) Written informed consent
Key exclusion criteria (1) Severe myelosupression
(2) Severe infectious disease
(3) Sensory neuropathy
(4) Psychological illness, Central nervous system damage or vascular brain disease
(5) Comorbidity or history of heart failure
(6) Intestinal lung disease or pulmonary fibrosis
(7) Prior radiotherapy for metastatic mesurable lesions
(8) History of severe allergy
(9) Pregnancy and breast feeding
(10) Severe comorbidity(renal failure, hepatic failure, hypertension, hypercalcemia)
(11) Symptomatic brain metastases
(12) multiple malignancy
(13) Any other cases who are regarded as inadequate for study enrollment by investigators
Target sample size 35

Research contact person
Last 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
1st name of contact person
1st name
Middle name
Last name Mai Hatta
Organization Nagoya University Graduate School of Medicine
Division name Department of Young Leaders&#39; Program in Medical Administration
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

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
2012 Year 02 Month 01 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
ESULTS: 
Forty patients who fulfilled the inclusion criteria participated in this study. The median treatment cycle number was 8 and the median dose intensities were 218 mg/m2/wk for cetuximab, 34 mg/m2/wk for oxaliplatin, and 821 mg/m2/d for capecitabine. One patient showed complete response and partial response was observed in 19 patients, giving an overall RR of 50% (95% confidence interval [CI], 33.8%-66.2%). Stable disease was obtained in 13 patients, resulting in a DCR of 82.5% (95% CI, 67.2%-92.7%). The PFS was 6.5 months (95% CI, 3.5-9.6 months), and the OS was 24.3 months (95% CI, 14.9-33.7 months). The safety profile revealed the common Grade 3/4 adverse events to be acneiform eruption (12.5%), peripheral neuropathy (7.5%), and elevated alanine transaminase levels (7.5%). Grade 3/4 thrombocytopenia and neutropenia occurred only in 5.0% and 2.5% of the patients, respectively. Grade 1 hand-foot syndrome (HFS) was not uncommon (20%), whereas Grade 2/3 HFS occurred in only 3 patients (7.5%). No deaths were reported within 30 days of the last dose.

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
2011 Year 11 Month 18 Day
Date of IRB
Anticipated trial start date
2012 Year 01 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 A Phase II Study of XELOX and Cetuximab as First-Line Therapy in Patients With KRAS Wild Type Metastatic Colorectal Cancer (FLEET2 Study).

Hazama S, Maeda H, Iwamoto S, Kim HM, Takemoto H, Kobayashi K, Sakamoto J, Nagata N, Oba K, Mishima H.

Clin Colorectal Cancer. 2016 Jul 18. pii: S1533-0028(16)30084-6. [Epub ahead of print]

Management information
Registered date
2012 Year 02 Month 01 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=R000008473

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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