UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000978 |
|---|---|
| Receipt number | R000001173 |
| Scientific Title | Phase I study of Docetaxel, Cisplatin and S-1 in patients with advanced or recurrent gastric cancer |
| Date of disclosure of the study information | 2008/01/09 |
| Last modified on | 2011/04/14 21:30:33 |
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Basic information
Public title
Phase I study of Docetaxel, Cisplatin and S-1 in patients with advanced or recurrent gastric cancer
Acronym
Phase I study of DCS therapy for advanced gastric cancer
Scientific Title
Phase I study of Docetaxel, Cisplatin and S-1 in patients with advanced or recurrent gastric cancer
Scientific Title:Acronym
Phase I study of DCS therapy for advanced gastric cancer
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Determining the maximum tolerable dose(MTD) and recomended dose(RD)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Safety
Key secondary outcomes
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
Docetaxel 20-40mg/m2
Cisplatin 60mg/m2
S-1 80mg/m2
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. histologically proven adenocarcinoma of unresectable or recurrent gastric cancer
2. Age 20-75
3. PS 0-1
4. Patients with assessable lesion
5. No previous chemotherapy, or never proven of refractory to S-1
6. No history of chemotherapy for other than gastric cancer
7. Adequate bone marrow function
8. Life expectancy > 8weeks
9. Written informed consent
Key exclusion criteria
1. Active infection
2. Severe peritoneal metastasis
3. Massive pleural effusion
4. CNS metastasis
5. Severe diarrhea
6. Suspected of Interstitial Pneumonitis
7. Other severe complications
8. Active malignancy
9. Pregnant
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuichi Hironaka |
Organization
Shizuoka Cancer Center
Division name
Division of Gastrointestinal Oncology
Zip code
Address
1007 Shimonagakubo Nagaizumi Sunto-gun Shizuoka 411-8777, Japan
TEL
055-989-5222
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shuichi Hironaka |
Organization
Shizuoka Cancer Center
Division name
Division of Gastrointestinal Oncology
Zip code
Address
1007 Shimonagakubo Nagaizumi Sunto-gun Shizuoka 411-8777, Japan
TEL
055-989-5222
Homepage URL
s.hironaka@scchr.jp
Sponsor or person
Institute
Shizuoka Cancer Center
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Aichi Cancer Center Central Hospital
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
| 2008 | Year | 01 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/20603245
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
Completed
Date of protocol fixation
| 2007 | Year | 05 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 01 | Month | 09 | Day |
Last modified on
| 2011 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001173
