UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017967 |
|---|---|
| Receipt number | R000020780 |
| Scientific Title | Clinical study of gemcitabine plus docetaxel in patient with refractory bone and soft tissue sarcomas |
| Date of disclosure of the study information | 2015/06/25 |
| Last modified on | 2018/06/20 11:36:48 |
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Basic information
Public title
Clinical study of gemcitabine plus docetaxel in patient with refractory bone and soft tissue sarcomas
Acronym
GEM+DTX in patient with sarcomas
Scientific Title
Clinical study of gemcitabine plus docetaxel in patient with refractory bone and soft tissue sarcomas
Scientific Title:Acronym
GEM+DTX in patient with sarcomas
Region
| Japan |
Condition
Condition
bone and soft tissue sarcoma
Classification by specialty
| Orthopedics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Chemotherapy using Ifosfamide, doxorubicin, cisplatin, etoposide, methotrexateis provided for bone and soft tissue sarcomas conventionally. There are some clinical problems that conventional chemotherapy resist tumor, myelosupression and necessity of hospitalization. Gemcitabine and docetaxel are already approved in Japan. The efficacy of chemotherapy with gemcitabine and docetaxel as a second line for refractory bone and soft tissue sarcomas was reported. Chemotherapy with gemcitabine and docetaxel had relatively low risk for myelosupression, this treatment can be indicated in daily out patient clinic. We plan a clinical study of gemcitabine and docetaxel for patient with refractory bone and soft tissue sarcomas.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
tumor response
survival
Key secondary outcomes
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
From June 25th, 2015 to December 31th, 2018
Gemcitabine675mg/m2, day1, day8
Docetaxel75mg/m2, day8
3 weeks or more interval
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
| 15 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Establishment of histopathological diagnosis of bone and soft tissue sarcomas
Non responder case with previous 1st line chemotherapy
Patient who had enough understanding after explanation of this study and presented document of agreement by their free will
Key exclusion criteria
Patient with severe liver or renal dysfunction
Patient with severe interstitial pneumonitis
PS4
Pregnant woman
Patient who was decided as incompatible by the principal investigator of this study
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Torigoe Tomoaki |
Organization
Juntendo University Urayasu Hospital
Division name
Orthopaedic Surgery
Zip code
Address
2-1-1, Tomioka, Urayasu-city, Chiba, 279-0021
TEL
047-353-3111
ttorigoe@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Torigoe Tomoaki |
Organization
Juntendo University Urayasu Hospital
Division name
Orthopaedic Surgery
Zip code
Address
2-1-1, Tomioka, Urayasu-city, Chiba, 279-0021
TEL
047-353-3111
Homepage URL
ttorigoe@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Urayasu Hospital
Institute
Department
Personal name
Funding Source
Organization
Juntendo University Urayasu Hospital
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
| 2015 | Year | 06 | Month | 25 | 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
Completed
Date of protocol fixation
| 2015 | Year | 06 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 25 | 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
| 2015 | Year | 06 | Month | 18 | Day |
Last modified on
| 2018 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020780
| 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 |
