UMIN-CTR Clinical Trial

Basic information
Public title	Combination chemotherapy of TS-1, oxaliplatin and irinotecan (TIROX) for unresectable gastric cancer; a phase I study
Acronym	TIROX for unresectable gastric cancer
Scientific Title	Combination chemotherapy of TS-1, oxaliplatin and irinotecan (TIROX) for unresectable gastric cancer; a phase I study
Scientific Title:Acronym	TIROX for unresectable gastric cancer
Region	Japan

Condition
Condition	gastric cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to determine the maximum-tolerated dose and recommended dose
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	MTD, RD
Key secondary outcomes	Response rate, Incidence and extent of adverse events, Time to treatment failure, Progressin free survival, Overall 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	TS-1 fixed dose L-OHP fixed dose CPT-11 dose escalation
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) Histological proven adenocarcinoma (2) unresectable gastric cancer (3) HER2 untested or negative (4) PS 0-1 (5) No history of chemotherapy or radiotherapy for unresectable gastric cancer (6) No massive ascites or massive pleural effusion retention (7) Patients without brain metastasis (8) Adequate organ function (9) Possible oral intake (10) Expected life span is more than 3 months (11) Written informed consent from patients "
Key exclusion criteria	"(1) Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy. (2) Recurrence after surgery (3) Past history of severe hypersensitivity to drugs (4) Diarrhea (4 or more times per day or watery diarrhea) (5) Body temperature of over 38 degrees Celsius or active infection (6) serious bone marrow suppression, a renal damage or a liver damage (7) Severe complications (8) Positive HBs antigen (9) Under treatment with flucytosine or atazanavir (10) Under treatment with phenytoin or warfarin (11) Continuous systemic steroid therapy (12) Pregnant women, women with the possibility of the pregnancy, or men who want their partners to become pregnant (13) Psychological disorder (14) Patients judged inappropriate for the study by the physicians "
Target sample size	18

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masahiro Gotou
Organization	Osaka Medical College Hospital
Division name	Chemotherapy Center
Zip code
Address	2-7 Daigaku-machi, Takatsuki City, Osaka, Japan
TEL	0726-683-1221
Email	in2030@osaka-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Tetsuji Terasawa
Organization	Osaka Medical College Hospital
Division name	Chemotherapy Center
Zip code
Address	2-7 Daigaku-machi, Takatsuki City, Osaka, Japan
TEL	072-683-1211
Homepage URL
Email	terasawat@osaka-med.ac.jp

Sponsor
Institute	Osaka Medical College Hospital
Institute
Department

Funding Source
Organization	Osaka Medical College Hospital
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	2017 Year 12 Month 20 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	Completed
Date of protocol fixation	2017 Year 11 Month 13 Day
Date of IRB	2017 Year 11 Month 13 Day
Anticipated trial start date	2017 Year 11 Month 13 Day
Last follow-up date	2020 Year 11 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 12 Month 20 Day
Last modified on	2020 Year 12 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034802