UMIN-CTR Clinical Trial

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

Gastric cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Department of Gastroenterological Surgery Graduate School of Medicine Osaka University

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

大阪大学附属病院（大阪府）　Osaka University Hospital (Osaka)

Date of disclosure of the study information

2010

Year

10

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2010

Year

09

Month

27

Day

Last modified on

2016

Year

03

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005117