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UMIN ID:

Recruitment status
Unique ID issued by UMIN C000000025
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Shinshu Gastroenterological Cancer Study Group
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000058

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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