UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007195 |
|---|---|
| Receipt number | 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 08:25:05 |
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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
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
hmishima@aichi-med-u.ac.jp
Public contact
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' Program in Medical Administration
Zip code
Address
65 Tsurumai Showa-ku Nagoya
TEL
052-744-2442
Homepage URL
m-hatta@med.nagoya-u.ac.jp
Sponsor or person
Institute
Epidemiological and Clinical research Information Network (ECRIN)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008473
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| Registered date | File name |
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