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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000004882
Receipt No. R000003868
Scientific Title Multicenter Phase II trial of Irinotecan plus S-1 with cetuximab (IRIS/Cet) in patients with EGFR positive and KRAS wild type of advanced/metastatic colorectal cancer
Date of disclosure of the study information 2011/01/15
Last modified on 2015/07/15

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Basic information
Public title Multicenter Phase II trial of Irinotecan plus S-1 with cetuximab (IRIS/Cet) in patients with EGFR positive and KRAS wild type of advanced/metastatic colorectal cancer
Acronym Phase II trial of Irinotecan plus S-1 with cetuximab in advanced/metastatic colorectal cancer
Scientific Title Multicenter Phase II trial of Irinotecan plus S-1 with cetuximab (IRIS/Cet) in patients with EGFR positive and KRAS wild type of advanced/metastatic colorectal cancer
Scientific Title:Acronym Phase II trial of Irinotecan plus S-1 with cetuximab in advanced/metastatic colorectal cancer
Region
Japan

Condition
Condition advanced/metastatic colorectal cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To assess the effectiveness and safety of irinotecan plus S-1 rejimen (IRIS) with Cetuximab combination therapy as the 2nd line treatment in patients with EGFR positive and KRAS wild type advanced/metastatic colorectal cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes Disease control 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 Irinotecan plus S-1 with cetuximab combination therapy
Cetuximab 400mg/m2 day1 and then 250mg/m2 day 8,15,22 weekly until PD, or Cetuximab 500mg/m2 day 1, 15, 29 biweekly until PD
Irinotecan 100 mg/m2 day1,15, 30 biweekly until PD
S-1
S-1 80mg [BSA<1.25m2] or 100mg [1.25m2<BSA<1.5m2] or 120mg [1.5m2<BSA]/body/day, day 1-14, q4weeks
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) Histologically confirmed colorectal cancer.
2) Clinically proven unresectable advanced/ metastatic colorectal cancer
3) Previously received on one regimen of oxaliplatin-contained chemotherapy (contained relapse less than 6 months from adjuvant chemotherapy)
4) Presence of at least one measurable lesion (according to the RECIST ver.1.1)
5) Immunohistochemical evidence of EGFR expression, either in the primary tumor or in metastatic tumor lesion
6) KRAS wild type (in codon 12, 13) confirmed, either in the primary tumor or in metastatic tumor lesion
7) Patients unaffected prior therapy
At least 4-6 weeks since prior radiotherapy
At least 4 weeks since prior operation for organ
At least 2 weeks since prior chemotherapy
At least 2 weeks since prior immune therapy, cytokine therapy or BRM therapy
8) More than 20 years of age
9) ECOG performance status 0-1
10) Adequate organ function for study treatment
WBC>=3000mm3, neutrophils>=1500/mm3
Platelets>=100000/mm3
Hemoglobin>=8.0g/dl
AST and ALT<=upper limit of normal (ULN)*2.5 (<=ULN*5 in case of liver metastasis)
Total bilirubin<=upper limit of normal (ULN)*2
Creatinine<=upper limit of normal (ULN)
11) Oral food intake possible
12) Life expectancy must be 3 months or longer after the combination therapy
13) Written informed consent
Key exclusion criteria 1) History of severe allergy
2) Simultaneous or metachronous double cancers
3) Symptomatic brain metastasis
4) Severe infectious disease
5) Severe complications (interstitial lung disease or pulmonary fibrosis, heart failure, kidney failure, hepatic failure, uncontrolable diabetes, Jaundice)
6) Paralytic or mechanical bowel obstruction
7) Massive pleural effusion or ascites
8) Wattery diarrhea
9) Patients who is receiving Atazanavir Sulfate or Flucytosine
10) Pregnant or lactating women or women of childbearing potential
11) Any other cases who are regarded as inadequate for study enrollment by the investigator.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshito Komatsu
Organization Hokkaido University Hospital
Division name Cancer center
Zip code
Address Nishi 5-chome, Kita 14-jo, Kitaku, Sapporo-city, Hokkaido
TEL 011-716-1161
Email ykomatsu@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Yuuki
Organization Hokkaido University Hospital
Division name Gastroenterology & Hematorogy
Zip code
Address Nishi 5-chome, Kita 14-jo, Kitaku, Sapporo-city, Hokkaido
TEL 011-706-5657
Homepage URL
Email satoshi-yuuki175@joy.ocn.ne.jp

Sponsor
Institute NPO Hokkaido Gastrointestinal Cancer Study Group (HGCSG)
Institute
Department

Funding Source
Organization NPO Hokkaido Gastrointestinal Cancer Study Group (HGCSG)
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
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 北海道大学病院(北海道)
北海道消化器癌化学療法研究会(HGCSG)関連施設

Other administrative information
Date of disclosure of the study information
2011 Year 01 Month 15 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Main results already published
Date of protocol fixation
2009 Year 12 Month 14 Day
Date of IRB
Anticipated trial start date
2010 Year 03 Month 01 Day
Last follow-up date
2013 Year 12 Month 31 Day
Date of closure to data entry
2013 Year 12 Month 31 Day
Date trial data considered complete
2014 Year 12 Month 01 Day
Date analysis concluded
2014 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 01 Month 15 Day
Last modified on
2015 Year 07 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003868

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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