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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006025
Receipt No. R000007129
Scientific Title The Effect of Preoperative PSK therapy in Advanced gastric cancer (pilot trial)
Date of disclosure of the study information 2011/07/22
Last modified on 2011/07/22

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Basic information
Public title The Effect of Preoperative PSK therapy in Advanced gastric cancer (pilot trial)
Acronym Preoperative PSK therapy in Advanced gastric cancer (pilot trial)
Scientific Title The Effect of Preoperative PSK therapy in Advanced gastric cancer (pilot trial)
Scientific Title:Acronym Preoperative PSK therapy in Advanced gastric cancer (pilot trial)
Region
Japan

Condition
Condition Gastric cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to measure plasma TGF-beta before and after PSK treatment in preoperative advanced gastric cancer patients(stageIb-III).The purpose of this study is to measure plasma TGF-beta before and after PSK treatment in preoperative advanced gastric cancer patients(stageIb-III).
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes TGF-beta
Key secondary outcomes CEA,CA19-9,General hematological examination,General biochemical examination

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Neoadjuvant PSK therapy (-)

Adjuvant Chemotherapy
Tegafur/gimeracil/oteracil potassium (S-1) plus Krestin (PSK)

Drug:Tegafur-gimeracil-oteracil potassium (TS-1)
80 mg/m2, PO from day 1 to day 28 of each 42 day cycle. Number of Cycles: 8
Drug: Krestin (PSK)
3g/day, 3 times (morning, daytime, evening)/day, 1g/time, from day 1 to day 336
Interventions/Control_2 Neoadjuvant PSK therapy
PSK: 3g/day, 3 times (morning, daytime, evening)/day, 1g/time, for two weeks before surgery.

Adjuvant Chemotherapy
Tegafur/gimeracil/oteracil potassium (S-1) plus Krestin (PSK)

Drug:Tegafur-gimeracil-oteracil potassium (TS-1)
80 mg/m2, PO from day 1 to day 28 of each 42 day cycle. Number of Cycles: 8
Drug: Krestin (PSK)
3g/day, 3 times (morning, daytime, evening)/day, 1g/time, from day 1 to day 336
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. Stage I-III stomach cancer before surgery
2. Patient whose age at the registration is ranging between 20 and 80 years old
3. Patient who has not received any preoperative therapy including radiotherapy, chemotherapy and immunotherapy
4. Patient with metachronous or synchronous multicancer
5. Patient who has no serious concurrent complications, and satisfies the following criteria
&#61692; Patient who has no diarrhea (watery stool)
&#61692; White blood cell count is more than 4,000 /mm3 and less than 12,000 /mm3
&#61692; Neutrophil count is more than 2,000 /mm3
&#61692; Platelet count is more than 100,000 /mm3
&#61692; Amount of hemoglobin is more than 9.0g/dL
&#61692; Serum AST (GOT), ALT (GPT) is less than 100IU/L
&#61692; Serum total bilirubin is less than 1.5 mg/dL
&#61692; Serum creatinine is less than 1.5 mg/dL
6. ECOG performance status of 0 - 2
7. Patient who has received an explanation of this study by assent documents, and has given written informed consent to participate in this study
Key exclusion criteria 1. Patient with bleeding from gut
2. Patient with severe fluid retention
3. Patient with infection, paralysis of intestine and ileus.
4. Patient who is pregnant or in lactation, or wish to become pregnant during this study
5. Patient with treatment of insulin or uncontrollable diabetes mellitus.
6. Patient with heart insufficiency
7. Patients with concurrent psychiatric disease or psychotic symptoms, and judged to have difficulties participating in the study
8. Patients receiving continuous administration of steroids
9. Patient who has experienced serious drug allergy in the past
10. Patient who is judged to be inappropriate as subject to this study by the principal investigator or the doctors in charge
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiko Watanabe
Organization Kitazato University, School of Medicine
Division name Surgery
Zip code
Address 1-15-1, kitazato, Sagamihara-city, Kanagawa 228-8555
TEL 042-778-8111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yamashita Keishi
Organization Kitazato University, School of Medicine
Division name Surgery
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Kitazato University, School of Medicine
Institute
Department

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
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

Other administrative information
Date of disclosure of the study information
2011 Year 07 Month 22 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
2008 Year 11 Month 19 Day
Date of IRB
Anticipated trial start date
2009 Year 01 Month 01 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
2011 Year 07 Month 22 Day
Last modified on
2011 Year 07 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007129

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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