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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000003156
Receipt No. 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

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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
Email 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
Email ktanabe2@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003828

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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