UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002361 |
|---|---|
| Receipt number | 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 17:05:53 |
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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
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
takayama@clin.med.tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima-Hokkaido cancer therapy clinical trial group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002893
