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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000001913
Receipt No. R000002326
Scientific Title A phase II study of S-1,cisplatin and lentinan in first-line treatment of unresectable or recurrent gastric cancer
Date of disclosure of the study information 2009/05/01
Last modified on 2009/04/27

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Basic information
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
Condition unresectable or recurrent gastric cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
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

Assessment
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

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 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

Eligibility
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

Research contact person
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

Public contact
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

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

Funding Source
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

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

Other administrative information
Date of disclosure of the study information
2009 Year 05 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
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
Other related information

Management information
Registered date
2009 Year 04 Month 27 Day
Last modified on
2009 Year 04 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002326

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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