UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015807 |
|---|---|
| Receipt number | R000018389 |
| Scientific Title | Phase I/II Study of TS-1/Oxaliplatin(SOX) for patients with unresectable advanced or recurrent gastric cancer |
| Date of disclosure of the study information | 2014/12/01 |
| Last modified on | 2024/05/07 09:34:30 |
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Basic information
Public title
Phase I/II Study of TS-1/Oxaliplatin(SOX) for patients with unresectable advanced or recurrent gastric cancer
Acronym
OCD1409 SOX
Scientific Title
Phase I/II Study of TS-1/Oxaliplatin(SOX) for patients with unresectable advanced or recurrent gastric cancer
Scientific Title:Acronym
OCD1409 SOX
Region
| Japan |
Condition
Condition
unresectable advanced or recurrent gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of TS-1/oxaliplatin (SOX) for patients with unresectable advanced or recurrent gastric cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
[Phase I part] To determine recommended dose (RD) and maximum tolerated dose (MTD)
[Phase II part] progression-free survival (PFS)
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
SOX
Oxaliplatin/TS-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 proven gastric cancer (Adenocarcinoma)
2) Unresectable advanced/recurrent gastric cancer, HER2 Negative case
3) Aged over 20 years at the time of registration
4) Performance Status(ECOG):0 or 1
5) A measurable lesions in RECIST criteria is unnecessary
6) Previously not treated chemotherapy or radiotherapy for unresectable gastric cancer
7) Able to receive oral treatment
8) Adequate organ function
9) Life expectance estimated>=3 months
10) Written IC
Key exclusion criteria
1) History of serious drug hypersensitivity
2) Pregnant, lactating or women of child-bearing potential. Men who want get partner pregnant
3) Active infections 4
4) Serious complications
5) Serious heart disease
6) Peptic ulcers
7) Sensory neuropathy
8) Diarrhea
9) A case with abdominal dropsy and the hydrothorax to need waste fluid by the sustained drainage custody
10) Brain metastasis
11) Other active malignancies (Nondisease period less than 5 years)
12) Continuous steroid treatment
13) Any other cases who are regarded as inadequate for study enrollment by the investigator
14) Administration contraindication of L-OHP , TS-1 , 5-FU
Target sample size
72
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kyoichi Ogata |
Organization
Gunma University, Graduate School of Medicine
Division name
Department of General Surgical Science
Zip code
Address
3-39-22 Showa-machi Maebashi Gunma 371-8511
TEL
027-220-8224
kogata@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kyoichi Kaira |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Oncology Clinical Development
Zip code
Address
3-39-22 Showa-machi Maebashi Gunma 371-8511
TEL
027-220-8222
Homepage URL
kkaira1970@yahoo.co.jp
Sponsor or person
Institute
Gunma University Graduate School of Medicine
Institute
Department
Personal name
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)
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
| 2014 | Year | 12 | Month | 01 | 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
| 2014 | Year | 11 | Month | 26 | Day |
Date of IRB
| 2014 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2014 | Year | 11 | Month | 26 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 01 | Day |
Last modified on
| 2024 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018389
