UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007360 |
|---|---|
| Receipt number | R000008670 |
| Scientific Title | Gemcitabine and docetaxel in advanced soft tissue sarcomas |
| Date of disclosure of the study information | 2012/02/22 |
| Last modified on | 2016/03/18 16:37:34 |
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Basic information
Public title
Gemcitabine and docetaxel in advanced soft tissue sarcomas
Acronym
Gemcitabine and docetaxel in advanced sarcomas
Scientific Title
Gemcitabine and docetaxel in advanced soft tissue sarcomas
Scientific Title:Acronym
Gemcitabine and docetaxel in advanced sarcomas
Region
| Japan |
Condition
Condition
advanced soft tissue sarcomas
Classification by specialty
| Surgery in general | Orthopedics | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to evaluate the efficacy and toxicity of fixed dose rate gemcitabine and docetaxel in patients with advanced soft tissue sarcoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tumor response was classified by Response Evaluation Criteria in Solid tumor (RECIST) guideline.
Key secondary outcomes
median survival period
adverse event
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Pharmacokinetic analysis of fixed dose rate gemcitabine
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
*Patients with histologically confirmed recurrent, metastatic or unresectable soft tissue sarcoma
*All patients had been previously treated with anthracycline-based chemotherapy
*ECOG performance status 0-2
*All patients had a life expectancy more than 2 months
*All patients had adequate hematologic
,renal and hepatic function
*After obtaining informed consent
Key exclusion criteria
*severe pleural effusion/cardiac effusion/ascites fluid
*serious cardiac disorder
*cerebrovascular disease
*uncontrolled diabetes
*uncontrolled hypertension
*symptomatic brain metastasis
*active infection
*pregnancy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Tsukushi |
Organization
Nagoya University Graduate School of Medicine
Division name
Orthopaedic Surgery
Zip code
Address
Tsurumai-cho, Showa-ku, Nagoya
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Nagoya University Graduate School of Medicine
Division name
Orthopaedic Surgery
Zip code
Address
Tsurumai-cho, Showa-ku, Nagoya
TEL
Homepage URL
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
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
| 2012 | Year | 02 | Month | 22 | 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
Terminated
Date of protocol fixation
| 2011 | Year | 08 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 22 | Day |
Last modified on
| 2016 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008670
