UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004882 |
|---|---|
| Receipt number | 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 10:14:32 |
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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
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
satoshi-yuuki175@joy.ocn.ne.jp
Sponsor or person
Institute
NPO Hokkaido Gastrointestinal Cancer Study Group (HGCSG)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003868
