UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The relationship between ocular toxicity induced by S-1 and pharmacokinetic analysis in both blood and tear
Title of the study (Brief title)	The relationship between ocular toxicity induced by S-1 and pharmacokinetic analysis in both blood and tear
Region	Japan

Condition
Condition	Malignancy
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	We evaluate the relationship between ocular toxicity induced by S-1 and drug concentrations in both blood and tear. Furthermore, we analyze genetic polymorphisms that relate with the metabolism of S-1.
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To identify the pharmacokinetic factors that is associated with ocular toxicity induced by S-1
Key secondary outcomes

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
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 or cytologically confirmed malignancy 2) Advanced cancers that S-1 are effective or gastric cancers that S-1 is indicated as adjuvant chemotherapy 3) Age is over 20 years. 4) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1. 5)Adequate organ function, evidenced by following laboratory results within 14 days prior to starting chemotherapy. Absolute neutrophil count>1,500/mm3 Platelet count<100,000/mm3 Hemoglobin<8.0g/dl Total bilirubin<2.0mg/dl AST and ALT<2.5 times the upper limit of normal(ULN) Creatinine<1.5mg/dl 6)Signed, written informed concent is obtained.
Key exclusion criteria	1) interstitial pneumonia, pulmonary fibrosis 2) Severe active infection 3) Serological positive for HBs-antigen or HCV-antibody 4) Unstable angina or myocardial infarction within 3 months 5) Severe complication (e.g., uncontrollable diabetis mellitus, liver disease) 6) Active synchronous cancer 7) Severe psychiatric disorder 8) Pregnant or lactating women, or men and women without wanting pregnancy 9) Severe hypersensitivity to medicine 10) Patients who were judged inappropriate for the study
Target sample size	100

Research contact person
Name of lead principal investigator	Yasutsuna Sasaki
Organization	Showa University School of Medicine
Division name	Division of Medical Oncology, Department of Medicine
Address	1-5-8 Hatanodai, Shinagawa, Tokyo
TEL	03-3784-8000
Email	yasutsuna@med.showa-u.ac.jp

Public contact
Name of contact person	Hiroo Ishida
Organization	Showa University School of Medicine
Division name	Division of Medical Oncology, Department of Medicine
Address	1-5-8 Hatanodai, Shinagawa, Tokyo
TEL	03-3784-8000
Homepage URL
Email	hishida@med.showa-u.ac.jp

Sponsor
Institute	Showa University School of Medicine
Institute
Department

Funding Source
Organization	Showa University School of Medicine
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	2014 Year 11 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 09 Month 11 Day
Anticipated trial start date	2014 Year 10 Month 01 Day
Last follow-up date	2018 Year 09 Month 30 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	2014 Year 10 Month 11 Day
Last modified on	2018 Year 10 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017926