UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030482 |
|---|---|
| Receipt number | 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 | 2020/12/21 09:32:27 |
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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
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
terasawat@osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034802
