UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026975 |
|---|---|
| Receipt number | 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 17:22:09 |
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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
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
osato@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029209
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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