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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000003372
Receipt No. R000004098
Scientific Title Study of PSK combination therapy aiming adverse events reduction by TS-1 in advanced gastric cancer
Date of disclosure of the study information 2010/04/01
Last modified on 2013/03/02

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Basic information
Public title Study of PSK combination therapy aiming adverse events reduction by TS-1 in advanced gastric cancer
Acronym Study of PSK combination therapy aiming adverse events reduction by TS-1 in advanced gastric cancer
Scientific Title Study of PSK combination therapy aiming adverse events reduction by TS-1 in advanced gastric cancer
Scientific Title:Acronym Study of PSK combination therapy aiming adverse events reduction 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 hematological or non-hematological grade 2>= adverse events in clinical stage II/III advanced gastric cancer with adjuvant TS-1
, study possibility of adverse events reduction or therapy continuity by PSK, and verify whether this regimen is useful or not as phase III protocol regimen.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes grade 2>= adverse events rate after starting protocol therapy (TS-1 + PSK combination therapy)
(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)

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-1:80-120mg/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
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) Stage II (except for T1) or stage III
3) Onset of hematological or non-hematological grade 2>= adverse events within 1-3 course of TS-1
4) No liver metastasis, peritoneal metastasis or distant metastasis and peritoneal washing cytology negative
5) Age 20-80 years
6) No history of pretreatment (radiotherapy, chemotherapy, hormone therapy etc.) except surgery
7) Written informed consent.
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 31

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Inoue Kentaro
Organization Kansai Medical University
Division name Department of Surgery
Zip code
Address 2-3-1 Shin-machi, Hirakata-city, Osaka
TEL 072-804-0100
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kansai Medical University
Division name Department of surgery
Zip code
Address
TEL 072-804-0101
Homepage URL
Email inoueke@hirakata.kmu.ac.jp

Sponsor
Institute Kansai Medical University
Institute
Department

Funding Source
Organization Department of Surgery, Kansai Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor none
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 関西医科大学附属枚方病院

Other administrative information
Date of disclosure of the study information
2010 Year 04 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 Terminated
Date of protocol fixation
2010 Year 03 Month 25 Day
Date of IRB
Anticipated trial start date
2010 Year 04 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
2012 Year 09 Month 01 Day
Date trial data considered complete
2012 Year 09 Month 01 Day
Date analysis concluded
2012 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 03 Month 24 Day
Last modified on
2013 Year 03 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004098

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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