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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000001858
Receipt No. R000002235
Scientific Title Multicenter phase II study of S-1 plus Weekly Cisplatin in first-line treatment of unresectable or reccurent gastric cancer
Date of disclosure of the study information 2009/04/07
Last modified on 2012/10/07

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Basic information
Public title Multicenter phase II study of S-1 plus Weekly Cisplatin in first-line treatment of unresectable or reccurent gastric cancer
Acronym The efficacy and safety of S-1 and weekly cisplatin combination therapy compared with the standard SP
Scientific Title Multicenter phase II study of S-1 plus Weekly Cisplatin in first-line treatment of unresectable or reccurent gastric cancer
Scientific Title:Acronym The efficacy and safety of S-1 and weekly cisplatin combination therapy compared with the standard SP
Region
Japan

Condition
Condition gastric cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to determine efficacy and safety of weekly cisplatin plus S-1 for unresectable or reccurent gastric cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes 1-year survival rate
Key secondary outcomes Adverse event rate, Progression free survival, Overall survival, Time to treatment failure

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 S-1 80mg/m2, day 1-14
Cisplatin 20mg/m2, day 1, 8
1 week rest
Interventions/Control_2 S-1 80mg/m2, day 1-21
Cisplatin 60mg/m2, day 8
2 week rest
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1)Histologically confirmed gastric cancer
2)Unresectable locally advanced and/or metastatic gastric cancer
3)Measurable disease or non-measurable but assessable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST)
4)No prior radiotherapy, chemotherapy or hormone therapy
5)ECOG Performance status 0-1
6)Age 20 to 75
7)No complication with peritoneal dissemination
8)Adequate function of major organs as defined below:
WBC 3,000-12,000/ul
Neutrophil count >1,500/ul
Hb >8.0g/dl
Platelet >100,000/ul
Bilirubin <1.5 mg/dL
AST and ALT <Upper limited normal*2 IU/L
Creatinine <Upper limited normal(mg/dL)
Creatinine clearanse >60ml/min
9)Voluntary written informed consent
Key exclusion criteria 1)Serious drug hypersensitivity or a history of drug allergy
2)Administered of flucytosine, phenytoin or warfarin potassium
3)Active infections
4)Serious complications (e.g., interstitial pneumonitis, pulmonary fibrosis, uncontrolled diabetes mellitus, renal failure or hepatic failure)
5)Uncontrolled watery diarrhea
6)Severe ascites or pleural effusion
7)Active double cancer
8)Pregnant women, possibly pregnant women, women wishing to become pregnant, and nursing mothers
9)Men who are currently attempting to conceive children
10)Judged ineligible for participation in the study by the investigator for safety reasons
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ichinosuke Hyodo
Organization University of Tsukuba
Division name Gastroenterology
Zip code
Address 2-1-1 Amakubo, Tsukuba-shi, Ibaraki-ken, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Toshikazu Moriwaki
Organization University of Tsukuba
Division name Gastroenterology
Zip code
Address
TEL
Homepage URL
Email tmoriwak@md.tsukuba.ac.jp

Sponsor
Institute Tsukuba Cancer Clinical Trial Group
Institute
Department

Funding Source
Organization Ibaraki epidemiological research of cancer
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Tsukuba Cancer Clinical Trial Group
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
2009 Year 04 Month 07 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
2008 Year 08 Month 17 Day
Date of IRB
Anticipated trial start date
2008 Year 10 Month 01 Day
Last follow-up date
2013 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
2012 Year 07 Month 31 Day
Date analysis concluded
2012 Year 08 Month 15 Day

Other
Other related information

Management information
Registered date
2009 Year 04 Month 07 Day
Last modified on
2012 Year 10 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002235

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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