UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015849 |
|---|---|
| Receipt number | R000018444 |
| Scientific Title | Phase I/II study of S-1, docetaxel, oxaliplatin combination chemotherapy (DOS) in patients with HER2-negative unresectable metastatic gastric cancer |
| Date of disclosure of the study information | 2014/12/04 |
| Last modified on | 2017/06/05 09:14:00 |
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Basic information
Public title
Phase I/II study of S-1, docetaxel, oxaliplatin combination chemotherapy (DOS) in patients with HER2-negative unresectable metastatic gastric cancer
Acronym
Phase I/II study of S-1, docetaxel, oxaliplatin combination chemotherapy (DOS) in patients with HER2-negative unresectable metastatic gastric cancer
Scientific Title
Phase I/II study of S-1, docetaxel, oxaliplatin combination chemotherapy (DOS) in patients with HER2-negative unresectable metastatic gastric cancer
Scientific Title:Acronym
Phase I/II study of S-1, docetaxel, oxaliplatin combination chemotherapy (DOS) in patients with HER2-negative unresectable metastatic gastric cancer
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Phase I: To assess maximum tolerated dose in order to determine recommended dose of docetaxel and oxaliplatin and S-1(DOS) in patients with HER2 negative unresectable metastatic gastric cancer.
Phase II: To investigate efficacy and safety of DOS combination for HER2 negative unresectable metastatic gastric cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of dose limiting toxicity
Response rate
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
Treatment with docetaxel (50mg/m2), Oxaliplatin (80-130 mg/m2), S-1 (80mg/m2) combination chemotherapy
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)Written informed consent.
2)Histologicaly (cytologically) proven gastric cancer.
3)HER2 negative method
4)Unresectable gastric cancer.
5)To have evaluable lesions.
6)No prior chemotherapy or no influence of prior therapy.
7)Tolerable function of bone marrow, liver and kidney.
8)PS 0 - 1.
9)Expected survival for 3 months.
10)Possible oral intake.
Key exclusion criteria
1)History of hypersensitivity to DCS.
2)Contraindication to Oxaliplatin, CDDP, S-1, G-CSF.
3)Infectious disease.
4)Severe compliaction.
5)Neuropathy greater than grade 2.
6)Brain metastasis with clinical symptoms.
7)Watery diarea.
8)Active double cancer.
9)Persons to be pregnant or to make pregnant.
Target sample size
59
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasushi Sato |
Organization
Tokushima University Graduate School of Biomedical Sciences
Division name
Department of Community Medicine for Gastroenterology and Oncology
Zip code
Address
3-18-15, Kuramoto-cho, Tokushima city, 770-8503
TEL
088-633-7124
sato.yasushi@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasushi Sato |
Organization
Tokushima University Graduate School of Biomedical Sciences
Division name
Department of Community Medicine for Gastroenterology and Oncology
Zip code
Address
3-18-15, Kuramoto-cho, Tokushima city, 770-8503
TEL
088-633-7124
Homepage URL
sato.yasushi@tokushima-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Oncology
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 | 04 | 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
| 2014 | Year | 10 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 02 | Day |
Last follow-up date
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 | 04 | Day |
Last modified on
| 2017 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018444
