UMIN-CTR Clinical Trial

Public title

A phase II study of S-1,cisplatin and lentinan in first-line treatment of unresectable or recurrent gastric cancer

Acronym

A phase II study of S-1,cisplatin and lentinan in first-line treatment of unresectable or recurrent gastric cancer

Scientific Title

A phase II study of S-1,cisplatin and lentinan in first-line treatment of unresectable or recurrent gastric cancer

Scientific Title:Acronym

A phase II study of S-1,cisplatin and lentinan in first-line treatment of unresectable or recurrent gastric cancer

Region

Japan

Condition

unresectable or recurrent gastric cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate safety and efficacy of chemotherapy with S-1, cisplatin and lentinan

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

1 year survival rate

Key secondary outcomes

Overall survival, response rate, progression free survival, time to treatment failure, relation between survival time and G/L ratio

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

Chemotherapy

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

75

years-old

>

Gender

Male and Female

Key inclusion criteria

1) Patients with unresected or recurrent gastric cancer that pathorogically confiemed

2)No privious treatment (patients who underwent aduvant chemotherapy except S-1 or cisplatin before more than 30 days can be registerd.)

3)Performance Status:0 or 1

4)Age between 20 and 75 years old when an informed concent was taken.

5)Patients who are expected to survive for more than three months

6)Patients who can eat oraly

7)Written informed consent to participate in this study.

8)Biology and biochemistry data are fit for the following criteria within 14 days before registration.

a) WBC; 3,500/mL
b) PLT; 100,000/mL
c) Hb; 8.0 g/dL
d) AST, ALT; ULN x 2.0
e) T-Bil; ULN x 2.0
f) CRE; ULN or CCR; 50ml/min

Key exclusion criteria

1)Patients who have a contraindication of S-1 or cisplatin

2)Patients who had infection or inflammatory disease

3)Patients who have or had severe heart disease

4)Patients who have severe commplication, such as ileus,intestinal pneumonia,fibroid lung, uncontrolled diabetes mellitus,renal failure, liver cirrhosis and so on

5)massive asites

6)multiple bone metastases

7)brain metastases

8)fresh gastrointestinal bleeding

9)diarrhea

10)mental disorder

11)synchronous multicancer

12)Patients pregnant or in lactation, or wish to become pregnant during this study. Male patients who intend to make someone pregnant during this study

13)Men who want a baby

14)Patient who is judged to be inappropriate for this study by the principal investigator or the doctors in charge

Target sample size

45

Name of lead principal investigator

1st name
Middle name
Last name	Wataru Kimura

Organization

Yamagata University Faculty of Medicine

Division name

Department Department of Gastroenterological, General, Breast and Thyroid Surgery

Zip code

Address

2-2-2 Iida-Nishi Yamagata City, Japan

TEL

023-628-5336

Email

Name of contact person

1st name
Middle name
Last name	Osamu Hachiya

Organization

Yamagata University Faculty of Medicine

Division name

Department of Gastroenterological, General, Breast and Thyroid Surgery

Zip code

Address

2-2-2 Iida-Nishi Yamagata City, Japan

TEL

Homepage URL

Email

Institute

Yamagata University Faculty of Medicine Department of Gastroenterological, General, Breast and Thyroid Surgery

Institute

Department

Personal name

Organization

Yamagata University Faculty of Medicine Department of Gastroenterological, General, Breast and Thyroid Surgery

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

Date of disclosure of the study information

2009

Year

05

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

Date of protocol fixation

2008

Year

09

Month

22

Day

Date of IRB

Anticipated trial start date

2008

Year

10

Month

01

Day

Last follow-up date

2011

Year

06

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2009

Year

04

Month

27

Day

Last modified on

2009

Year

04

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002326