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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026975
Receipt No. R000029209
Scientific Title Phase II trial of S-1 and lentinan combined chemotherapy for elderly patients with unresectable advanced gastric cancer
Date of disclosure of the study information 2017/04/13
Last modified on 2017/05/12

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Basic information
Public title Phase II trial of S-1 and lentinan combined chemotherapy for elderly patients with unresectable advanced gastric cancer
Acronym Phase II trial of S-1 and lentinan
Scientific Title Phase II trial of S-1 and lentinan combined chemotherapy for elderly patients with unresectable advanced gastric cancer
Scientific Title:Acronym Phase II trial of S-1 and lentinan
Region
Japan

Condition
Condition Unresectable advanced gastric cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of TS-1 plus lentinan combined chemotherapy for elderly patients with unresectable advanced gastric cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Overall survival
Key secondary outcomes

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 TS-1/lentinan
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
70 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Histologically proven gastric cancer
2. Aged over 70 years at the time of registration
3.Unresectable advanced gastric cancer
4.Performance status (ECOG): 0-2
5.Previously not treated chemotherapy or radiotherapy for unresectable gastric cancer
6.Sufficient organ functions
7.Life expectance estimated>=3 months
8.Able to receive oral S-1 treatment
9.Written informed consent
Key exclusion criteria 1.Administration contraindication of S-1
2.Active infectious
3.Serious heart disease or the past history
4.Serious coexisting illness
5.Massive abdominal or pleural effusion
6.Multiple bone metastases
7.Brain metastasis or the past history
8.Active gastrointestinal bleeding
9. Mental disorder to need a psychotropic drug
10. Hypersensitivity to lentinan
11.Inappropriate patients for this study judged by the physicians
Target sample size 38

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideyuki Ishida
Organization Saitama Medical Center, Saitama Medical University
Division name Department of digestive tract and general surgery
Zip code
Address 1981 Kamoda, Kawagoe-shi, SAITAMA 350-8550, JAPAN
TEL 048-228-3619
Email 05hishi@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satomi Oyama
Organization Saitama Medical Center, Saitama Medical University
Division name Department of digestive tract and general surgery
Zip code
Address 1981 Kamoda, Kawagoe-shi, SAITAMA 350-8550, JAPAN
TEL 048-228-3619
Homepage URL
Email osato@saitama-med.ac.jp

Sponsor
Institute Saitama Medical Center, Saitama Medical University
Institute
Department

Funding Source
Organization Saitama Medical Center, Saitama Medical University
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
2017 Year 04 Month 13 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 Completed
Date of protocol fixation
2008 Year 09 Month 03 Day
Date of IRB
Anticipated trial start date
2008 Year 10 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 04 Month 13 Day
Last modified on
2017 Year 05 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029209

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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