UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003253 |
|---|---|
| Receipt number | 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 08:21:37 |
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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
hmishima@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mai Hatta |
Organization
Young Leaders' 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
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
Japan
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
| 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
Value
https://center6.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 | |
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| Registered date | File name |
