UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007372 |
|---|---|
| Receipt number | R000008499 |
| Scientific Title | PhaseII study of Combination FOLFIRI with Cetuximab in patients with advanced/metastatic colorectal cancer previously received oxaliplatin-based chemoterapy. |
| Date of disclosure of the study information | 2012/02/24 |
| Last modified on | 2013/06/12 10:41:10 |
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Basic information
Public title
PhaseII study of Combination FOLFIRI with Cetuximab in patients with advanced/metastatic colorectal cancer previously received oxaliplatin-based chemoterapy.
Acronym
PhaseII study of Combination FOLFIRI with Cetuximab in patients with advanced/metastatic colorectal cancer previously received oxaliplatin-based chemoterapy.
Scientific Title
PhaseII study of Combination FOLFIRI with Cetuximab in patients with advanced/metastatic colorectal cancer previously received oxaliplatin-based chemoterapy.
Scientific Title:Acronym
PhaseII study of Combination FOLFIRI with Cetuximab in patients with advanced/metastatic colorectal cancer previously received oxaliplatin-based chemoterapy.
Region
| Japan |
Condition
Condition
Colorectal Cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate efficacy and safety of cetuximab plus FOLFIRI regimen as 2nd line in Japanese patients with EGFR-detectable and KRAS 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 response rate according to internal organs
Disease control rate(CR+PR+SD)
Dose Intensity
Safety
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)+ Cetuximab
1) Cetuximab : 500 mg/m2/bi-week
2) CPT-11 : 100 or 150 mg/m2/bi-week
3) l-LV : 200 mg/m2/bi-week
4) 5-FU/bolus : 400 mg/m2/bi-week
5) 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
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshito Akagi |
Organization
Kurume University
Division name
Department of Surgery
Zip code
Address
67, Asashi machi, Kurume city, Fukuoka, Japan 830-0011
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshito Akagi |
Organization
Kurume University
Division name
Department of Surgery
Zip code
Address
67, Asashi machi, Kurume city, Fukuoka, Japan 830-0011
TEL
0942-35-3311
Homepage URL
yoshisg@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University School of medicine, Department of Surgery
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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 | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 02 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 24 | Day |
Last modified on
| 2013 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008499
