UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001858 |
|---|---|
| Receipt number | 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 09:54:33 |
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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
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
tmoriwak@md.tsukuba.ac.jp
Sponsor or person
Institute
Tsukuba Cancer Clinical Trial Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002235
