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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000012063
Receipt No. R000014103
Scientific Title Multicenter Phase II study of combination therapy with S-1 plus Irinotecan plus Cetuximab (MetronomicIRIS/Cmab combination therapy) in patients with KRAS wild type unresectable colorectal cancer, who had previously received on fluoropyrimidine , oxaliplatin , irinotecan and bevacizumab. (KSCOG CR-06)
Date of disclosure of the study information 2013/10/18
Last modified on 2016/10/28

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Basic information
Public title Multicenter Phase II study of combination therapy with S-1 plus Irinotecan plus Cetuximab (MetronomicIRIS/Cmab combination therapy) in patients with KRAS wild type unresectable colorectal cancer, who had previously received on fluoropyrimidine , oxaliplatin , irinotecan and bevacizumab.
(KSCOG CR-06)
Acronym Multicenter Phase II study of MetronomicIRIS/Cmab combination therapy in patients with KRAS wild type unreseactable colorectal cancer.
(KSCOG CR-06)
Scientific Title Multicenter Phase II study of combination therapy with S-1 plus Irinotecan plus Cetuximab (MetronomicIRIS/Cmab combination therapy) in patients with KRAS wild type unresectable colorectal cancer, who had previously received on fluoropyrimidine , oxaliplatin , irinotecan and bevacizumab.
(KSCOG CR-06)
Scientific Title:Acronym Multicenter Phase II study of MetronomicIRIS/Cmab combination therapy in patients with KRAS wild type unreseactable colorectal cancer.
(KSCOG CR-06)
Region
Japan

Condition
Condition Colorectal cancer
Classification by specialty
Medicine in general Gastroenterology Surgery in general
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy and safety of MetronomicIRIS(S-1/CPT-11)/Cmab combination therapy in patients with KRAS wild type unreseactable advanced/reccurent colorectal cancer, who had previously received on fluoropyrimidine, oxaliplatin, irinotecan and bevacizumab.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Progression free survival
Key secondary outcomes Overall response rate
Disease control rate
Overall survival
Safety
Dose intensity

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 MetronomicIRIS(S-1/CPT-11)/Cmab combination therapy

S-1:50 or 60 or 80mg/body/day(day3-7,10-14,17-21,24-28)
CPT-11:60mg/m2(day1,8,15)
Cmab*:250mg/m2(day1,8,15,22)
*:400mg/m2 for the initial dosing(day1)

every 4 weeks
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) Patients with histologically proven colorectal cancer
2) KRAS wild type
3) Age 20 years<= 80
4) Patients who had previously received on fluoropyrimidine, oxaliplatin, irinotecan and bevacizumab
5) ECOG performance status 0-2
6) Presence of measurable lesion judged by enhanced CT (according to the RECIST)
7) Patiens have enough organ function based on blood test within 28day before registration
1.WBC>=3,000/mm3<=12,000/mm3
2.Neurtophils>=1,500/mm3
3.Platelets>=100,000/mm3
4.Hemoglobin>=9.0g/dl
5.Total bilirubin<=2.0mg/dl
6.AST and ALT<=100U/L(ALT<=200U/L with liver metastases)
7.Serum creatinine <=1.5 mg/dl
8.creatinine clearance>=50ml/min
8) Be able to take oral drugs
9) Life expectancy at least 3 months
10) Written informed consent
Key exclusion criteria 1) With contraindicate S-1
2) Patients under treatment with flucytosine,phenytoin,warfarin potassium
3) Patients who is receiving Atazanavir Sulfate
4) Severe bone marrow suppression
5) Active infection and inflammation
6) Comorbidity or history of interstitial lung disease or pulmonary fibrosis
7) Massive pleural effusion or ascites
8) Watery stools or diarrhea
9) Severe complications
10) Simultaneous or metachronous double cancers
11) Pregnant or lactating women or women of childbearing potential
12) Other patients who are unfit for the study as determined by the attending physician
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yutaka Ogata
Organization Kurume University Medical Center
Division name Department of Surgery
Zip code
Address 155-1 Kokubu-Machi, Kurume, Fukuoka 839-0863, Japan
TEL 0942-22-6111
Email yogata@med.kurume-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yutaka Ogata
Organization Kurume University Medical Center
Division name Department of Surgery
Zip code
Address 155-1 Kokubu-Machi, Kurume, Fukuoka 839-0863, Japan
TEL 0942-22-6111
Homepage URL
Email yogata@med.kurume-u.ac.jp

Sponsor
Institute Kurume University Medical Center
Institute
Department

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
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
2013 Year 10 Month 18 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 Terminated
Date of protocol fixation
2013 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 11 Month 01 Day
Last follow-up date
2016 Year 07 Month 31 Day
Date of closure to data entry
2016 Year 07 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 10 Month 17 Day
Last modified on
2016 Year 10 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014103

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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