UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015917 |
|---|---|
| Receipt number | R000018524 |
| Scientific Title | Second line chemotherapy using gemcitabine and docetaxel for soft tissue sarcoma |
| Date of disclosure of the study information | 2014/12/12 |
| Last modified on | 2019/06/16 12:01:21 |
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Basic information
Public title
Second line chemotherapy using gemcitabine and docetaxel for soft tissue sarcoma
Acronym
Second line chemotherapy using gemcitabine and docetaxel for soft tissue sarcoma
Scientific Title
Second line chemotherapy using gemcitabine and docetaxel for soft tissue sarcoma
Scientific Title:Acronym
Second line chemotherapy using gemcitabine and docetaxel for soft tissue sarcoma
Region
| Japan |
Condition
Condition
soft tissue sarcoma except for small round cell tumor
Classification by specialty
| Orthopedics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of second-line chemotherapy using gemcitabine and docetaxel after failure of Adriamycin based chemotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
reduction of tumor volume
Key secondary outcomes
adverse effect
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
GEM (900 mg/m2 day 1, 8) + DOC (70 mg/m2 day 8)
5 courses
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patient with soft tissue sarcoma except for small round cell tumor after failure of adriamycin based chemotherapy who expresses his/her assent
Key exclusion criteria
patient who doesn't show his/her assent
patient considered to be not suitable for participating this trial
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Akihito |
| Middle name | |
| Last name | Nagano |
Organization
Gifu University school of medicine
Division name
The department of Orthopaedic surgery
Zip code
502-1194
Address
1-1 Yanagido, Gifu
TEL
0582306333
a-nagano@lucky.odn.ne.jp
Public contact
Name of contact person
| 1st name | Akihito |
| Middle name | |
| Last name | Nagano |
Organization
Gifu University school of medicine
Division name
The department of Orthopaedic surgery
Zip code
502-1194
Address
1-1 Yanagido, Gifu
TEL
0582306333
Homepage URL
a-nagano@lucky.odn.ne.jp
Sponsor or person
Institute
Gifu University school of medicine
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
The department of Orthopaedic surgery
Address
1-1 Yanagido, Gifu
Tel
0582306333
a-nagano@lucky.odn.ne.jp
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
岐阜大学病院（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 12 | Day |
Related information
URL releasing protocol
Nothing
Publication of results
Unpublished
Result
URL related to results and publications
Nothing
Number of participants that the trial has enrolled
0
Results
No participant.
Results date posted
| 2019 | Year | 06 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
No participant.
Participant flow
No participant.
Adverse events
No participant.
Outcome measures
No participant.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2014 | Year | 12 | Month | 03 | Day |
Date of IRB
| 2014 | Year | 12 | Month | 03 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2018 | Year | 02 | 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
| 2014 | Year | 12 | Month | 11 | Day |
Last modified on
| 2019 | 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=R000018524
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
