UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase I/II study of chemotherapy using Irinotecan, S-1 plus Oxaliplatin (IRISOX therapy) for unresectable pancreatic cancer
Title of the study (Brief title)	IRISOX therapy for unresectable pancreatic cancer
Region	Japan

Condition
Condition	unresectable pancreatic cancer
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to determine the recommended dose for the phase II study and to evaluate the response rate in the phase II study.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	Phase I : MTD, RD Phase II : response rate
Key secondary outcomes	Safety, progression-free survival

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: dose escalation S-1: dose escalation Oxaliplatin: fixed dose
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1. Pathologically diagnosed Adenocarcinoma or Adenosquamous carcinoma 2. Aged 20 to 75 years old 3. ECOG PS of 0 or 1 4. Life expectancy > 3 months. 5. Sufficient oral intake 6. Unresectable 7. The subject has measurable disease. 8. No prior therapy for pancreatic cancer 9. Adequate organ functions 10. Written informed consent
Key exclusion criteria	1. Patients with contraindication for the medication of Irinotecan, S-1 and L-OHP 2. History of serious drug hypersensitivity or a history of drug allergy 3. Pregnancy 4. Active infection 5. Severe complications 6. Peripheral neuropathy 7. Serious diarrhea 8. Intestinal pneumonitis or pulmonary fibrosis 9. Much ascites or pleural effusion or pericardial effusion 10. Active double cancer 11. Symptomatic brain metastasis 12. Regular use of frucitocin, fenitoin or warfarin 13. Having UGT1A1*6/*6, UGT1A1*28/*28, or UGT1A1*6/*28 gene 14. HBV carrier who has to take nucleotide analogues during chemotherapy 15. Inappropriate for this study judged by the attending physician
Target sample size	25

Research contact person
Name of lead principal investigator	Mitsuhiro Kida
Organization	Kitasato University School of Medicine
Division name	Department of Gastroenterology
Address	1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan
TEL	+81-42-778-8111
Email	m-kida@kitasato-u.ac.jp

Public contact
Name of contact person	Kosuke Okuwaki
Organization	Kitasato University School of Medicine
Division name	Department of Gastroenterology
Address	1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan
TEL	+81-42-778-8111
Homepage URL
Email	kokuwaki@kitasato-u.ac.jp

Sponsor
Institute	Department of Gastroenterology Kitasato University School of Medicine
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	北里大学病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2015 Year 03 Month 27 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 03 Month 04 Day
Anticipated trial start date	2015 Year 04 Month 01 Day
Last follow-up date
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	2015 Year 03 Month 27 Day
Last modified on	2018 Year 01 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019651