UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002094 |
|---|---|
| Receipt number | R000002513 |
| Scientific Title | Multicenter PhaseII study of Combination FOLFIRI with Erbitux in advanced/metastatic colorectal cancer: EGFR positive and KRAS wild type |
| Date of disclosure of the study information | 2009/06/22 |
| Last modified on | 2018/09/20 08:20:07 |
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Basic information
Public title
Multicenter PhaseII study of Combination FOLFIRI with Erbitux in advanced/metastatic colorectal cancer:
EGFR positive and KRAS wild type
Acronym
Multicenter PhaseII study of Combination FOLFIRI with Erbitux in advanced/metastatic colorectal cancer:
EGFR positive and KRAS wild type
Scientific Title
Multicenter PhaseII study of Combination FOLFIRI with Erbitux in advanced/metastatic colorectal cancer:
EGFR positive and KRAS wild type
Scientific Title:Acronym
Multicenter PhaseII study of Combination FOLFIRI with Erbitux in advanced/metastatic colorectal cancer:
EGFR positive and KRAS wild type
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
This study is designed to evaluate efficacy of cetuximab plus FOLFIRI regimen in Japanese patients with EGFR-detectable and KRAS wild type metastatic colorectal carcinoma
Basic objectives2
Safety
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, disease control rate, dose intensity, response rate according to internal organs, safety profile
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
FOLFIRI (CPT-11, 5-FU bolus, 5-FU infusional, l-LV)+ Erbitux
Cetuximab 400 mg/m2(day1)
Cetuximab 250 mg/m2/week, (except day 1)
CPT-11 100 or 150 mg/m2/bi-week
l-LV 200 mg/m2/bi-week
5-FU/bolus 400 mg/m2/bi-week
5-FU/infusional 2,400 mg/m2/bi-week (day 1-3)
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 in the primary or metastatic tumor tissue is confirmed by immunohistochemical evaluation regardless of intensity
(3)KRAS wild type in codon 12 and 13 in the primary or metastatic tumor tissue is confirmed
(4)Curatively unresectable mCRC patients who had received and failed at least one regimen of oxaliplatin-contained chemotherapy
(5)Age 20 years<=
(6)ECOG performance status 0-1
(7)Presence of at least one measurable lesion (according to the RECIST)
(8)Prior chemotherapy was done in the first study treatment before at least 28days
(9)Patiens have enough organ function for study treatment
1. WBC>=3,000/mm3 , Neurtophils>=1,500/mm3
2. Platelets>=100,000/mm3
3. Hemoglobin>=9.0g/dl
4. Total bilirubin<=upper limit of normal (ULN)*3
5. AST and ALT<=upper limit of normal (ULN)*3 (<=ULN*5 in case of liver metastasis)
6. Creatinine<=upper limit of normal (ULN)*2
(10)Life expectancy of 3 months
(11)Written informed consent
Key exclusion criteria
(1)Severe bone marrow suppression
(2)Wattery diarrhea
(3)Severe infectious disease
(4)Massive pleural effusion or ascites
(5)Comorbidity or history of heart failure
(6)Comorbidity or history of interstitial lung disease or pulmonary fibrosis
(7)Paralytic or mechanical bowel obstruction
(8)Jaundice
(9)Patients who is receiving Atazanavir Sulfate
(10)History of severe allergy
(11)Pregnant or lactating women or women of childbearing potential
(12)Severe comorbidity (uncontrolable diabetes, hypertension, hypercarcemia etc)
(13)Symptomatic brain metastasis
(14)Simultaneous or metachronous double cancers
(15)Any other cases who are regarded as inadequate for study enrollment by the investigator.
Target sample size
50
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
| 2009 | Year | 06 | Month | 22 | 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
Anticancer Res. 2014 Apr;34(4):1967-73.
Results:Sixty-seven patients (59.8%) were EGFR-positive and KRAS wild-type. The mean age of the enrolled patients (n=60) was 62.6 years (range=37-82 years). The response rate was 31.7% and stable disease was observed in 53.3%. No objective response was observed in patients with BRAF or PIK3CA mutations. The median PFS and OS were 7.4 and 18.2 months, respectively. Grade-3/4 adverse events were leucopenia (26.7%), neutropenia (43.3%), paronychia (10.0%), fissure (10.0%) and acne-like rash (5.0%).
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
| 2008 | Year | 11 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter phase II study of second-line cetuximab plus folinic acid/5-fluorouracil/irinotecan (FOLFIRI) in KRAS wild-type metastatic colorectal cancer: the FLIER study.
Iwamoto S, Hazama S, Kato T, Miyake Y, Fukunaga M, Matsuda C, Bando H, Sakamoto J, Oba K, Mishima H.
Management information
Registered date
| 2009 | Year | 06 | Month | 19 | 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=R000002513
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
