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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030482
Receipt No. R000034802
Scientific Title Combination chemotherapy of TS-1, oxaliplatin and irinotecan (TIROX) for unresectable gastric cancer; a phase I study
Date of disclosure of the study information 2017/12/20
Last modified on 2019/06/21

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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 Open public recruiting
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
2019 Year 06 Month 21 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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