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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004266
Receipt No. R000005117
Scientific Title A phase II feasibility trial of TS-1/PSK therapy as adjuvant chemotherapy for gastric cancer with TS-1/CDDP as neoadjuvant chemotherapy.
Date of disclosure of the study information 2010/10/01
Last modified on 2016/03/28

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Basic information
Public title A phase II feasibility trial of TS-1/PSK therapy as adjuvant chemotherapy for gastric cancer with TS-1/CDDP as neoadjuvant chemotherapy.
Acronym A phase II trial of TS-1/PSK therapy for gastric cancer with TS-1/CDDP as neoadjuvant chemotherapy.
Scientific Title A phase II feasibility trial of TS-1/PSK therapy as adjuvant chemotherapy for gastric cancer with TS-1/CDDP as neoadjuvant chemotherapy.
Scientific Title:Acronym A phase II trial of TS-1/PSK therapy for gastric cancer with TS-1/CDDP as neoadjuvant chemotherapy.
Region
Japan

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

Objectives
Narrative objectives1 Today, TS-1 administration for 1 year is the standard adjuvant treatment for stage II, III advanced gastric cancer based on the results of ACTS-GC. However, there are many opinions that TS-1 monotherapy is not sufficient for stage III. So, more effective chemotherapy to improve treatment results is under review. In this feasibility study, we investigate efficacy of TS-1 and PSK combination therapy as adjuvant chemotherapy for clinical stage III and curative resectable stage IV patients who received TS-1 and CDDP combination therapy as neoajuvant chemotherapy.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes 1. Adverse event and its frequency
2. Medication compliance (Relative performance: RP%)
3. Recurrence-free survival time and survival time
Key secondary outcomes

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 Neoadjuvant chemotherapy
TS-1: 80mg/m2, Day1-21, p.o..
CDDP: 60mg/m2, Day8.
1 course takes 28 days.
As a rule, 2 courses.
Adjuvant chemotherapy
TS-1:
TS-1 administration according to body surface area starts within 56 days after surgery for 1 year.
2 times (after breakfast, after dinner)/day.
Day1-28.
1 course takes 42 days.
Maximum 8 courses for 1 year after surgery.
PSK: 3g/day, 3 times (morning, daytime, evening)/day, 1g/time, for 1 year. PSK administration is daily including TS-1 holidays.
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. Gastric Adenocarcinoma
2. Stage3 or curative resectable stage4
3. Treated with S-1 and CDDP as neoadjuvant chemotherapy
4. R0 or R1 resection
5. Age between 20 and 80
6, ECOG performance status of 0 or 1
7. No prior treatment for gastric cancer
8. Major organ function preserved
9. Oral intake possible
10. With written informed consent
Key exclusion criteria 1.Double cancer.
2.Patients with administration contraindication of TS-1.
3.Patients who need continuing use of flucytosine, phenytoin, warfarin potassium.
4.Patients with severe complication (such as ileus, interstitial lung disease, lung fibrosis, diabetes that is difficult to control, heart failure, renal failure, liver failure).
5.Pregnant or lactating patients.
6.Male who have intention that get with child.
7.Patients who are not suitable for this trial by doctor's judgment.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiyuki Fujiwara
Organization Graduate School of Medicine Osaka University
Division name Department of Gastroenterological Surgery
Zip code
Address 2-2,E2,Yamadaoka,Suita,Osaka,565-0871,Japan
TEL 06-6879-3251
Email yfujiwara@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiyuki Fujiwara
Organization Graduate School of Medicine Osaka University
Division name Gastroenterological Surgery
Zip code
Address 2-2,E2,Yamadaoka,Suita,Osaka,565-0871,Japan
TEL 06-6879-3251
Homepage URL
Email yfujiwara@gesurg.med.osaka-u.ac.jp

Sponsor
Institute Department of Gastroenterological Surgery Graduate School of Medicine Osaka 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 大阪大学附属病院(大阪府) Osaka University Hospital (Osaka)

Other administrative information
Date of disclosure of the study information
2010 Year 10 Month 01 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 Terminated
Date of protocol fixation
2010 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 12 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 09 Month 27 Day
Last modified on
2016 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005117

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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