UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013313 |
|---|---|
| Receipt number | R000015506 |
| Scientific Title | Study of PSK combination therapy to the reduction of adverse events by TS-1 in advanced gastric cancer |
| Date of disclosure of the study information | 2014/03/03 |
| Last modified on | 2015/12/16 13:42:01 |
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Basic information
Public title
Study of PSK combination therapy to the reduction of adverse events by TS-1 in advanced gastric cancer
Acronym
Study of PSK combination therapy to the reduction of adverse events by TS-1 in advanced gastric cancer
Scientific Title
Study of PSK combination therapy to the reduction of adverse events by TS-1 in advanced gastric cancer
Scientific Title:Acronym
Study of PSK combination therapy to the reduction of adverse events by TS-1 in advanced gastric cancer
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
For patients with clinical stage II/III advanced gastric cancer, the efficacy of TS-1 therapy combined with PSK is verified by adverse events reduction and compliance
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse events rate after starting chemotherapy (number of adverse event cases /number of enrolled cases)
Key secondary outcomes
TS-1 compliance (number of therapy completion courses/number of therapeutic plan courses)
Quality of Life
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
TS-1: 80-120mg/day
2 times/day, p.o., day1-28.
One course takes 42 days.
For one year from surgery.
PSK: 3g/day
3 times/day(1g/time), p.o., daily.
For one year including TS-1 holidays.
Interventions/Control_2
TS-1: 80-120mg/day
2 times/day, p.o., day1-28.
One course takes 42 days.
For one year from surgery.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Histological proven gastric cancer
2)Surgical operated by D2 lymphadenectomy and curability A or B
3)Clinical Stage 2 (except for T1) or stage 3
4)No liver metastasis, peritoneal metastasis or distant metastasis and peritoneal washing cytology negative
5)Age 20-80 years
6)No pretreatment (radiotherapy, chemotherapy, hormone therapy etc.) except surgery
7)Capable of oral administration within 6 weeks after surgery
8)Clear to the criteria as below
Leukocyte: >LLN or 4,000/mm3
Blood platelet count: >10*104/mm3
Total bilirubin: <1.5mg/dl
AST(GOT) ALT(GPT): <LLN*2.5
Serum creatinine: <LLN
9)Judged to be capable of tolerating this treatment, and who have given written informed consent to participate in this study
Key exclusion criteria
1)Schronous, mtaschronous double cancer/ multiple cancer
2)administration contraindication of TS-1 (refer package insert)
3)Regular use of flucytosine, phenytoin or warfarin potassium
4)History of severe drug allergy (grade 3>=)
5)Severe complications such as paralytic ileus, bowel obstruction, interstitial pneumonitis or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure and hepatic failure etc.
6)Severe watery diarrhea
7)Pregnancy or lactation
8)Male intension that get with child
9)HIV positive
10)Patients who are recognized as inadequate patients by doctors whit responsibility in this study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Usuki Hisashi |
Organization
Faculty of Medicine, Kagawa University
Division name
Department of Gastroenterological Surgery
Zip code
Address
1750-1 Ikedo, Miki-machi, Kida-gun, Kagawa
TEL
087-898-5111
usuki@kms.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Usuki Hisashi |
Organization
Faculty of Medicine, Kagawa University
Division name
Department of Gastroenterological Surgery
Zip code
Address
1750-1 Ikedo, Miki-machi, Kida-gun, Kagawa
TEL
087-898-5111
Homepage URL
usuki@kms.ac.jp
Sponsor or person
Institute
Faculty of Medicine, Kagawa University
Department of Gastroenterological Surgery
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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 | 03 | Month | 03 | 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
| 2009 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | 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 | 03 | Month | 03 | Day |
Last modified on
| 2015 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015506
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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