UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001025 |
|---|---|
| Receipt number | R000001236 |
| Scientific Title | Phase I study of preoperative Docetaxel, Cisplatin and S-1 for patients with advanced gastric cancer |
| Date of disclosure of the study information | 2008/02/15 |
| Last modified on | 2009/06/16 14:47:50 |
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Basic information
Public title
Phase I study of preoperative Docetaxel, Cisplatin and S-1 for patients with advanced gastric cancer
Acronym
Phase I study of preoperative DCS therapy for advanced gastric cancer
Scientific Title
Phase I study of preoperative Docetaxel, Cisplatin and S-1 for patients with advanced gastric cancer
Scientific Title:Acronym
Phase I study of preoperative DCS therapy for advanced gastric cancer
Region
| Japan |
Condition
Condition
Patients with unresectable gastric cancer due to limited invasion and/or metastasis.
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Determine the maximum tolerable dose (MTD) and recommended dose (RD) as a preoperative chemotherapy which are achievable the safety surgical resection.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Safety
Key secondary outcomes
Adverse events
Ratio of complete treatment
Response rate of preoperative chemotherapy
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 day 1, 15
Cisplatin dat 1, 15
S-1 80mg/m2 day 1-14
every 28 days for 2 cycles followed by gastrectomy
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 confirmed as gastric cancer
2. patients with unresectable advanced gastric cancer due to limited invasion and/or metastasis.
3. Age 20-75
4. PS 0-1
5. No prior therapy including chemotherapy, radiation and surgery.
6. Patients who can take medication orally.
7. Sufficient function of important organs.
8. Life expectancy > 8weeks
9. Written informed consent
Key exclusion criteria
1. Active infection
2. Other severe complications
3. Active double cancer
4. CNS metastasis
5. Pericardiac fluid
6. Mortor paralysis or peripheral neural disturbance.
7. History of severe allergy against drug.
8. Severe peritoneal metastasis
9. Pregnant women or women who like to be pregnant.
10. Doctor' s dicision not to be registered to this study.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Fujimura |
Organization
Kanazawa University Hospital
Division name
Gastroenterologic Surgery
Zip code
Address
Takara-machi 13-1, Kanazawa
TEL
076-265-2362
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sachio Fushida |
Organization
Kanazawa University Hospital
Division name
Gastroenterologic Surgery
Zip code
Address
Takara-machi 13-1, Kanazawa
TEL
076-265-2362
Homepage URL
Sponsor or person
Institute
Dept. of Gastroenterologic Surgery,
Kanazawa University Hospital
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
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 | 02 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2007 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 02 | Month | 12 | Day |
Last modified on
| 2009 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001236
