UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003156 |
|---|---|
| Receipt number | R000003828 |
| Scientific Title | Randomized Phase II trial of TS-1 based thrapy vs TS-1 based therapy + LNT for advanced or Recurrent Gastric Cancer |
| Date of disclosure of the study information | 2010/03/10 |
| Last modified on | 2018/07/02 21:00:28 |
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Basic information
Public title
Randomized Phase II trial of TS-1 based thrapy vs TS-1 based therapy + LNT for advanced or Recurrent Gastric Cancer
Acronym
TS-1 based thrapy vs TS-1 based therapy + LNT (Randomized Phase II trial)
Scientific Title
Randomized Phase II trial of TS-1 based thrapy vs TS-1 based therapy + LNT for advanced or Recurrent Gastric Cancer
Scientific Title:Acronym
TS-1 based thrapy vs TS-1 based therapy + LNT (Randomized Phase II trial)
Region
| Japan |
Condition
Condition
Inoperable or Recurrent Gastric Cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Efficacy and Safety of TS-1 based therapy and TS-1 based therapy + LNT for inoperable and recurrent gastric cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary Endpoint : Time to Treatment Failure(TTF)
Secondary Endpoint : Overall Survival(OS), Progression Free Survival(PFS), Quality of Life(QOL), Response Rate(RR), Safety, Compliance
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
TS-1 based therapy
Interventions/Control_2
TS-1 based therapy + LNT
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 proven advaneced or recurrent gastric cancer gastric adenocarcinoma.
2) No previous treatment other than chemotherapy or surgery.
3) ECOG Performance Status 0-2
4) Age > 20 years old
5) Life expectancy over 3 months
6) Adequate organ function for enrollment before 14 days.
7) Measurable lesions according to RECIST guidelines.
8)Sufficient oral in
9) Written informed consent.
Key exclusion criteria
1) Drug hypersensitivity or severe drug allergy.
2) With infectious disease which needs treatment.
3) Uncontrolled medical conditions (e.g., congestive heart failure, ileus, interstitial pneumonia, pulmonary fibrosis, diabetes, interstitial pneumonia, pulmonary fibrosis, renal failure).
4) Patients with severe dysfunction of bone marrow
5) Patients with severe dysfunction of liver
6) Patients who need flucitosine
7) With uncontrolled pleural effusion or ascites.
8) Patients with any symptoms due to metastases to the central nervous system
9) Active concomitant malignancy.
10) Pregnant or lactating women
11) men with intent to bear baby
12) Any other patient whom the physician in charge of the study judges to be not eligible
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideki Odan |
Organization
Hiroshima University Hospital
Division name
gastrointestinal surgery
Zip code
Address
1-2-3 Kasumi Minamiku Hiroshima, Japan
TEL
0822575222
hohdan@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuaki Tanabe |
Organization
Hiroshima University Hospital
Division name
gastrointestinal surgery
Zip code
Address
1-2-3 Kasumi Minamiku Hiroshima, Japan
TEL
0822575222
Homepage URL
ktanabe2@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Deputy Director of Cancer Treatment Center Department of Medical Oncology
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
| 2010 | Year | 03 | Month | 10 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 02 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 03 | 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
| 2010 | Year | 02 | Month | 09 | Day |
Last modified on
| 2018 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003828
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
