UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of Cetuximab + Irinotecan + S-1 as first line therapy in metastatic colorectal cancer with KRAS wild type
Title of the study (Brief title)	CIRIS study
Region	Japan

Condition
Condition	Metastatic colorectal cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of Cetuximab + Irinotecan + S-1 as first line in metastatic colorectal cancer with KRAS wild type
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	Overall Survival Progression Free Survival Safety Best response: % change at baseline

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	IRIS + Cetuximab Cetuximab loading dose 400mg/m2, 250 mg/m2/week Irinotecan 100 mg/m2/biweekly S-1 80,100,120 mg/twice/day 1-14, following two weeks off
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. Metastatic colorectal cancer 3. KRAS wild type 4. No prior chemotherapy for metastatic colorectal cancer 5. Age over 20 6. ECOG Performance Status 0-1 7. A measurable lesion is confirmed with objective documents such as CT, MRI and the X-ray check within 30th before registration. 8. Patients have enough organ function for study treatment. 9. Enable to internal use 10. Life expectancy of more than 3 months 11. Written informed consent
Key exclusion criteria	1. Sever myeloablation 2. Severe infectious disease 3. Sensory alteration or paresthesia interfering with function 4. A mental disorder, nucleus neuropathy, cerebrovascular neuropathy failure 5. Comorbidity or history of heart failure 6. Interstitial lung disease or pulmonary fibrosis 7. Prior radiotherapy for primary and metastases tumors 8. History of severe allergy 9. Women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test 10. Sever comorbidity (renal failure, liver failure, hypertension, high calcium, etc) 11. Symptomatic brain metastases 12. Patient have metachronous multiple malignancy 13. Any other cases who are regarded as inadequate for study enrollmet by investigators
Target sample size	30

Research contact person
Name of lead principal investigator	Yoshinori Sakai
Organization	Tsuchiura kyodo general hospital
Division name	Department of Gastroenterology
Address	11-7 Manabeshinmachi, Tsuchiura, Ibaraki, Japan
TEL
Email

Public contact
Name of contact person	Toshiki Masuishi
Organization	Tsuchiura kyodo general hospital
Division name	Department of Gastroenterology
Address	11-7 Manabeshinmachi, Tsuchiura, Ibaraki, Japan
TEL
Homepage URL
Email

Sponsor
Institute	Tsuchiura kyodo general hospital
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)

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	2010 Year 11 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 09 Month 16 Day
Anticipated trial start date	2010 Year 11 Month 01 Day
Last follow-up date	2015 Year 01 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 11 Month 18 Day
Last modified on	2018 Year 11 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005471