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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000004534
Receipt No. R000005418
Scientific Title A feasibility study of Krestin (PSK) plus TS-1 combination therapy for resectable gastric cancer.
Date of disclosure of the study information 2010/11/10
Last modified on 2010/11/10

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Basic information
Public title A feasibility study of Krestin (PSK) plus TS-1 combination therapy for resectable gastric cancer.
Acronym A feasibility study of Krestin (PSK) plus TS-1 combination therapy for resectable gastric cancer.
Scientific Title A feasibility study of Krestin (PSK) plus TS-1 combination therapy for resectable gastric cancer.
Scientific Title:Acronym A feasibility study of Krestin (PSK) plus TS-1 combination therapy for resectable gastric cancer.
Region
Japan

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

Objectives
Narrative objectives1 In this feasibility study, we evaluate tolerability of PSK/TS-1 alternate therapy as adjuvant therapy for gastric cancer. PSK/TS-1 alternate therapy is alternate-week administration of TS-1 and PSK administration during TS-1 holidays.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Rate of treatment accomplishment
Key secondary outcomes 1.Relative performance (RP:%)
2.Adverse event and its frequency
3.5 year recurrence-free survival time and 5 year overall survival time

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 plus PSK therapy
PSK is given 3 g/day daily in 1 to 3 divided doses a day for 1 week within 8 weeks after surgery.
Then, TS-1 is given in two divided doses a day (after breakfast and dinner) for 1 week.
1 course takes 2 weeks.
Maximum 24 courses for 1 year after surgery.
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 In this study, we use Japanese Classification of Gastric cancer (The 14th Edition).
1. Histologically proven gastric cancer.
2. Stage IB, IIA, IIB, IIIA, IIIB except for T2, N0 patients.
3. R0.
4. Age between 20 and 80 years at the time of consent acquisition.
5. Patients can take orally within 8 weeks after surgery (day of surgery as 0 day).
6. No preoperative treatment, such as radiotherapy, chemotherapy and hormone therapy.
7. No severe disorder of renal function, hepatic function, bone-marrow function.
8. Performance status of 0-2.
9. No severe complication, such as myelosuppression, diarrhea, infection.
10. Written informed consent.
Key exclusion criteria 1. Fresh gastrointestinal bleeding.
2. Active double cancer.
3. Administration contraindication of TS-1.
4. Continuous use of flucytosine, phenytoin or warfarin potassium.
5. History of severe drug allergy (over grade 3).
6. Severe complications such as paralytic ileus, bowel obstruction, interstitial pneumonitis or pulmonary fibrosis, uncontrolled diabetic mellitus, heart failure, renal failure and hepatic failure etc.
7. Severe watery diarrhea.
8. Female who are pregnant, nursing, suspected of being pregnant or hope to become pregnant during the study period.
9. No birth-control.
10. HIV positive.
11. Patients judged inappropriate for the study by their physicians.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiyuki Natsume
Organization Graduate School of Medicine, Chiba University
Division name Department of Frontier Surgery
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba 260-8670, JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Graduate School of Medicine, Chiba University
Division name Department of Frontier Surgery
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba 260-8670, JAPAN
TEL
Homepage URL
Email

Sponsor
Institute Graduate School of Medicine, Chiba University
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 千葉大学医学部附属病院(千葉県)

Other administrative information
Date of disclosure of the study information
2010 Year 11 Month 10 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 Preinitiation
Date of protocol fixation
2010 Year 08 Month 12 Day
Date of IRB
Anticipated trial start date
2011 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
2010 Year 11 Month 10 Day
Last modified on
2010 Year 11 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005418

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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