UMIN-CTR Clinical Trial

Basic information
Public title	Feasibility study of combination therapy with S-1 plus irinotecan in patients with EGFR positive KRAS mutation type unresectable colorectal cancer, who had previously received on irinotecan, oxaliplatin and fluoropyrimidine, bevacizumab
Acronym	Feasibility study of combination therapy with S-1 plus irinotecan in patients with EGFR positive KRAS mutation type unresectable colorectal cancer, who had previously received on irinotecan, oxaliplatin and fluoropyrimidine, bevacizumab
Scientific Title	Feasibility study of combination therapy with S-1 plus irinotecan in patients with EGFR positive KRAS mutation type unresectable colorectal cancer, who had previously received on irinotecan, oxaliplatin and fluoropyrimidine, bevacizumab
Scientific Title:Acronym	Feasibility study of combination therapy with S-1 plus irinotecan in patients with EGFR positive KRAS mutation type unresectable colorectal cancer, who had previously received on irinotecan, oxaliplatin and fluoropyrimidine, bevacizumab
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 S-1 plus irinotecan combination therapy in patients with EGFR positive KRAS mutaiton type unreseactable advanced/reccurent colorectal cancer, who had documented PD of 5FU based chemotherapy, and had received irinotecan and oxaliplatin, bevacizumab.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Progression free survival(PFS)
Key secondary outcomes	Overall response rate Overall survival Disease control rate (CR+PR+SD) 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	S-1/irinotecan combination therapy Irinotecan 100 mg/m2(day1,15), S-1 80-120mg/day, PO from day1 to day 14 of each 28 day cycle.
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 and clinically proven unresectable advanced/recurrent colorectal cancer 2) KRAS mutation type 3) Age 20 years<= 80 4) Patients who had previously received on irinotecan, oxaliplatin and fluoropyrimidine,bevacizumab 5) ECOG performance status 0-1 6) Presence of measurable lesion judged by enhanced CT (according to the RECIST 1.1) 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<=100IU/L(ALT<=200IU/L with liver metastases) 7.ALT<=100IU/L(ALT<=200IU/L with liver metastases) 8. Creatinine<=1.2mg/dl 9. 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) Severe bone marrow suppression 4) Active infection and inflammation 5)Comorbidity or history of interstitial lung disease or pulmonary fibrosis 6) Watery stools or diarrhea 7) Severe complications 8)Simultaneous or metachronous double cancers 9)Pregnant or lactating women or women of childbearing potential 10) Other patients who are unfit for the study as determined by the attending physician
Target sample size	25

Research contact person
Name of lead principal investigator	1st name Middle name Last name Akihiko Tsuchida
Organization	Tokyo Medical University
Division name	3rd department of surgery
Zip code
Address	6-7-1 Nish-Shinjyuku Shinjyuku Tokyo
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name Kenji Kastumata
Organization	Tokyo Medical University
Division name	3rd department of surgery
Zip code
Address	6-7-1 Nish-Shinjyuku Shinjyuku Tokyo
TEL	03-3342-6111
Homepage URL
Email	k-katsu@tokyo-med.ac.jp

Sponsor
Institute	3rd department of surgery Tokyo Medical University
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 01 Month 14 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	2012 Year 10 Month 02 Day
Date of IRB	2012 Year 10 Month 02 Day
Anticipated trial start date	2012 Year 10 Month 02 Day
Last follow-up date	2022 Year 01 Month 01 Day
Date of closure to data entry	2022 Year 01 Month 01 Day
Date trial data considered complete	2022 Year 01 Month 01 Day
Date analysis concluded	2022 Year 01 Month 01 Day

Other
Other related information

Management information
Registered date	2013 Year 01 Month 09 Day
Last modified on	2022 Year 01 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011411