UMIN-CTR Clinical Trial

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

Gastric cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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

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

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

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

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

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

Institute

Graduate School of Medicine, Chiba 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

千葉大学医学部附属病院（千葉県）

Date of disclosure of the study information

2010

Year

11

Month

10

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

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 related information

Registered date

2010

Year

11

Month

10

Day

Last modified on

2010

Year

11

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005418