UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000025 |
|---|---|
| Receipt number | R000000058 |
| Scientific Title | Docetaxel/5'DFUR or Docetaxel for advanced or recurrent gastric cancer as 2nd line chemotherapy |
| Date of disclosure of the study information | 2006/12/31 |
| Last modified on | 2005/08/19 11:31:31 |
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Basic information
Public title
Docetaxel/5'DFUR or Docetaxel for advanced or recurrent gastric cancer as 2nd line chemotherapy
Acronym
2nd line Docetaxel/5'DFUR for advanced or recurrent gastric cancer
Scientific Title
Docetaxel/5'DFUR or Docetaxel for advanced or recurrent gastric cancer as 2nd line chemotherapy
Scientific Title:Acronym
2nd line Docetaxel/5'DFUR for advanced or recurrent gastric cancer
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
1. evaluation of efficacy and safety of Docetaxel/5'DFUR or Docetaxcel for advanced or recurrent gastric cancer as 2nd line chemotherapy
2. comparison of efficacy and safety between Docetaxel/5'DFUR and Docetaxcel for advanced or recurrent gastric cancer as 2nd line chemotherapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
response rate, survival, toxicity
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Docetaxel 60 mg/m2 iv (tri-weekly) and 5'DFUR 600 mg/body orally (daily), as one course. This is continued until PD or unacceptable toxicity occurs or patients choose to discontinue the treatment.
Interventions/Control_2
Docetaxel 60 mg/m2 iv (tri-weekly), as one course. This is continued until PD or unacceptable toxicity occurs or patients choose to discontinue the treatment.
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 gastric cancer 2. measurable or evaluable leisions 3. second line chemotherapy 4. adequate interval after first line chemotherapy 5. performance status 0-2 6. adequate organ function 7. estimated survival period: more than 3 months 8. written informed consent
Key exclusion criteria
1. serious complications 2. infection 3. peripheral neuropathy 4. other cancers (except cured cancer) 5. brain metastasis 6. severe pleural effusion or severe ascites 7. allergy to polysorbate 80 8. drug allergy 9. pregnant or lactational
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fukuto Maruta |
Organization
Shinshu University School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
Address
Asahi 3-1-1, Matsumoto, Nagano, 390-8621, Japan
TEL
0263-37-2654
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fukuto Maruta |
Organization
Shinshu University School of Medicine
Division name
Gastroenterological Surgery
Zip code
Address
Asahi 3-1-1, Matsumoto, Nagano, 390-8621, Japan
TEL
0263-37-2654
Homepage URL
Sponsor or person
Institute
Shinshu Gastroenterological Cancer Study Group
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
| 2006 | Year | 12 | Month | 31 | 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
Date of protocol fixation
| 2003 | Year | 10 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 12 | 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
| 2005 | Year | 07 | Month | 21 | Day |
Last modified on
| 2005 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000058
