UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of TS-1+PSK therapy as adjuvant chemotherapy during 2years against advanced gastric cancer.
Acronym	Phase II study of TS-1+PSK therapy as adjuvant chemotherapy during 2years against advanced gastric cancer
Scientific Title	Phase II study of TS-1+PSK therapy as adjuvant chemotherapy during 2years against advanced gastric cancer.
Scientific Title:Acronym	Phase II study of TS-1+PSK therapy as adjuvant chemotherapy during 2years against advanced gastric cancer
Region	Japan

Condition
Condition	Advanced gastric cancer
Classification by specialty	Surgery in general Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To verify the efficacy and safety of the long immunochemotherapy treatment using PSK+TS-1 for advanced gastric cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Relapse-Free Survival 5years
Key secondary outcomes	Overall Survival 5years Drug compliance Adverse events Serial changes of tumor markers

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	1.TS-1 80 mg/m2, PO from day 1 to day 28 of each 42 day cycle. 2.PSK 3g, PO from day 1 to 2 years.
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.Patient who is pathologically confirmed as gastric cancer 2.Patient who has received surgery with D2 or more lymph node dissection and whose final curability of surgical resection is grade A or B 3.Patient whose final stage is II (except for T1), IIIA, or IIIB 4.Patient without liver, peritoneal and distant metastasis, and who is negative in peritoneal cytological diagnosis 5.Patient whose age at the registration is ranging between 20 and 80 years old 6.Patient who has not received any preoperative therapy including radiotherapy, chemotherapy and immunotherapy 7.Patient who has received surgery for gastric cancer within six weeks before the registration, and is judged to be capable of oral administration 8.Patient who has no serious concurrent complications, and satisfies the following criteria 9.White blood cell count>= 4,000 /mm3 10.Platelet count: >= 100,000 /mm3 11.Serum total bilirubin: <= 1.5 mg/dL 12.Serum AST (GOT), ALT (GPT): < 2.5 * ULN 13.Serum creatinine: < ULN 14.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 metachronous or synchronous multicancer 2.Patient who contraindicates to TS-1 3.Patient who requires continuous use of flucytosine, phenytoin or warfarin potassium 4.Patient who has experienced serious drug allergy over grade 3 in the past 5.Patient with serious complications including paralysis of intestine, ileus, interstitial pneumonitis, fibroid lung, uncontrollable diabetes mellitus, heart insufficiency, renal insufficiency or hepatic insufficiency 6.Patient with diarrhea (watery stool) 7.Patient who is pregnant or in lactation, or wish to become pregnant during this study 8.Patient who is judged to be inappropriate as subject to this study by the principal investigator or the doctors in charge
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hideaki Shimada
Organization	Toho University School of Medicine
Division name	Department of Surgery
Zip code
Address	6-11-1 Omori-Nishi, Ota-ku, Tokyo
TEL	03-3762-4151
Email	hideaki.shimada@med.toho-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hideaki Shimada
Organization	Toho University School of Medicine
Division name	Department of Surgery
Zip code
Address	6-11-1 Omori-Nishi, Ota-ku, Tokyo
TEL	03-3762-4151
Homepage URL
Email	hideaki.shimada@med.toho-u.ac.jp

Sponsor
Institute	Toho 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

Other administrative information
Date of disclosure of the study information	2010 Year 10 Month 28 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	2010 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date	2010 Year 01 Month 22 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 10 Month 20 Day
Last modified on	2017 Year 05 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005276

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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