UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001913 |
|---|---|
| Receipt number | 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 22:38:31 |
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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
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
Sponsor or person
Institute
Yamagata University Faculty of Medicine Department of Gastroenterological, General, Breast and Thyroid Surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002326
