UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004419 |
|---|---|
| Receipt number | R000005276 |
| Scientific Title | Phase II study of TS-1+PSK therapy as adjuvant chemotherapy during 2years against advanced gastric cancer. |
| Date of disclosure of the study information | 2010/10/28 |
| Last modified on | 2017/05/01 10:30:04 |
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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
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
hideaki.shimada@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005276
