UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008590 |
|---|---|
| Receipt number | R000010091 |
| Scientific Title | Phase II study of daily administration of TS-1 plus lentinan(LNT) in advanced or recurrent gastric cancer. |
| Date of disclosure of the study information | 2012/08/01 |
| Last modified on | 2013/09/09 12:54:02 |
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Basic information
Public title
Phase II study of daily administration of TS-1 plus lentinan(LNT) in advanced or recurrent gastric cancer.
Acronym
Phase II study of daily administration of TS-1 plus lentinan(LNT) in advanced or recurrent gastric cancer.
Scientific Title
Phase II study of daily administration of TS-1 plus lentinan(LNT) in advanced or recurrent gastric cancer.
Scientific Title:Acronym
Phase II study of daily administration of TS-1 plus lentinan(LNT) in advanced or recurrent gastric cancer.
Region
| Japan |
Condition
Condition
Advanced or recurrent gastric cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate clinical usefulness of daily administration of TS-1 plus lentinan(LNT) in advanced or recurrent gastric cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Time to Treatment Failure
Key secondary outcomes
Overall Survival, Progression Free Survival, Response Rate, Adverse Effect, Quality of Life
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 is administered orally at Monday, Wednesday, Friday and Sunday. Lentinan is administered intravenousely once a week.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically demonstrated adenocarcinoma of advanced or recurrent gastric carcinoma.
2) Measurable disease or non-measurable but assessable disease according to the Response Evaluation Criteria in Solid Tumors. (RECIST)
3) No prior radiotherapy, chemotherapy or hormone therapy.
4) Adequate organ functions:
i) WBC >=3000/mm3 and <=12000/mm3,
ii) neutrophils >=2000/mm3,
iii) platelets >=100,000/mm3,
iv) hemoglobin >=8.0g/dL,
v) total bilirubin <=1.5mg/dL,
vi) AST(GOT)/ALT(GPT) <=100IU/L,
vii) creatinine clearance >=50mL/min.
5) ECOG Performance status:0-2
6) Expected survival over 3 months.
7) Age of 20 years or older.
8) Sufficient oral intake.
9) Normal ECG.
10) Written informed consent
Key exclusion criteria
1) Limitation of use of TS-1.
2) Infection and inflammation.
3) Serious heart disease.
4) Symptomatic pulmonary fibrosis or interstitial pneumonia.
5) Severe complications, such as ileus, uncontrolled diabetes mellitus, heart failure, renal failure and hepatocirrhosis.
6) A large amount of pleural effusion or peritoneal fluid.
7) Widespread bone-marrow metastases.
8) Brain metastasis.
9) Fresh bleeding from digestive organs.
10) Diarrhea.
11) Severe mental disorders.
12) Active synchronous malignancy.
13) Patients under treatment with flucytosine, phenytoin or warfarin potassium.
14) Pregnant females, possibly pregnant
females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy.
15) Other patients who are unfit for the study as determined by the attending physician.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaaki Oka |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Digestive Surgery and Surgical Oncology
Zip code
Address
1-1-1 Minamikokushi, Ube, Yamaguchi 755-8505, Japan
TEL
0836-22-2264
sigefumi@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigefumi Yoshino |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Digestive Surgery and Surgical Oncology
Zip code
Address
1-1-1 Minamikokushi, Ube, Yamaguchi 755-8505, Japan
TEL
0836-22-2264
Homepage URL
sigefumi@yamaguchi-u.ac.jp
Sponsor or person
Institute
Department of Digestive Surgery and Surgical Oncology, Yamaguchi University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Digestive Surgery and Surgical Oncology, Yamaguchi University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
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
| 2012 | Year | 08 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 10 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | 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
| 2012 | Year | 08 | Month | 01 | Day |
Last modified on
| 2013 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010091
