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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002361
Receipt No. R000002893
Scientific Title Phase II study of modified S-1, docetaxel and cisplatin combination chemotherapy (mDCS) in patients with unresectable metastatic gastric cancer.
Date of disclosure of the study information 2009/10/01
Last modified on 2015/01/30

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Basic information
Public title Phase II study of modified S-1, docetaxel and cisplatin combination chemotherapy (mDCS) in patients with unresectable metastatic gastric cancer.
Acronym Phase II study of mDCS for unresectable metastatic gastric cancer
Scientific Title Phase II study of modified S-1, docetaxel and cisplatin combination chemotherapy (mDCS) in patients with unresectable metastatic gastric cancer.
Scientific Title:Acronym Phase II study of mDCS for unresectable metastatic gastric cancer
Region
Japan

Condition
Condition Gastric cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate efficacy of modified DCS (docetaxel 50mg/m2, CDDP 60mg/m2, TS-1 80mg/m2) for unresectable metastatic gastric cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes Overall survival, progression free survival, time to response, duration of response, safety

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 Treatment with docetaxel+Cisplatin+S-1 combination chemotherapy.
Docetaxel 50mg/m2 iv (d8), Cisplatin 60mg/m2 iv (d8), S-1 80mg/m2 po (BID) (d1-14)
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1)Written informed consent.
2)Histologicaly (cytologically) proven gastric cancer.
3)Unresectable gastric cancer.
4)To have measurable lesions.
5)No prior chemotherapy or no influence of prior therapy.
6)Tolerable function of bone marrow, liver and kidney.
7)PS 0 - 1.
8)Expected survival for 3 months.
9)Possible oral intake.
Key exclusion criteria 1)History of hypersensitivity to DCS.
2)Contraindication to TXT, CDDP, S-1, G-CSF.
3)Infectious disease.
4)Severe compliaction.
5)Neuropathy greater than grade 2.
6)Brain metastasis with clinical symptoms.
7)Watery diarea.
8)Active double cancer.
9)Persons to be pregnant or to make pregnant.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuji Takayama
Organization Tokushima University Hospital.
Division name Department of Gastroenterology
Zip code
Address 3-18-15, Kuramoto-cho, Tokushima city
TEL 0886337124
Email takayama@clin.med.tokushima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuji Takayama
Organization Tokushima University Hospital.
Division name Department of Gastroenterology
Zip code
Address 3-18-15, Kuramoto-cho, Tokushima
TEL 0886337124
Homepage URL
Email takayama@clin.med.tokushima-u.ac.jp

Sponsor
Institute Tokushima-Hokkaido cancer therapy clinical trial group
Institute
Department

Funding Source
Organization Self-funding
Organization
Division
Category of Funding Organization Self funding
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
2009 Year 10 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
2009 Year 09 Month 18 Day
Date of IRB
Anticipated trial start date
2010 Year 05 Month 01 Day
Last follow-up date
2013 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 08 Month 21 Day
Last modified on
2015 Year 01 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002893

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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