UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006025 |
|---|---|
| Receipt number | 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 18:19:52 |
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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
 Patient who has no diarrhea (watery stool)
 White blood cell count is more than 4,000 /mm3 and less than 12,000 /mm3
 Neutrophil count is more than 2,000 /mm3
 Platelet count is more than 100,000 /mm3
 Amount of hemoglobin is more than 9.0g/dL
 Serum AST (GOT), ALT (GPT) is less than 100IU/L
 Serum total bilirubin is less than 1.5 mg/dL
 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
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
Sponsor or person
Institute
Kitazato University, 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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007129
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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