UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023089 |
|---|---|
| Receipt number | R000026609 |
| Scientific Title | chemotherapy for primary bone sarcoma over 41 except for Ewing sarcoma |
| Date of disclosure of the study information | 2016/07/10 |
| Last modified on | 2018/01/09 17:45:11 |
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Basic information
Public title
chemotherapy for primary bone sarcoma over 41 except for Ewing sarcoma
Acronym
chemotherapy for primary bone sarcoma over 41
Scientific Title
chemotherapy for primary bone sarcoma over 41 except for Ewing sarcoma
Scientific Title:Acronym
chemotherapy for primary bone sarcoma over 41
Region
| Japan |
Condition
Condition
primary bone sarcoma
Classification by specialty
| Orthopedics | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to investigate treatment for primary bone sarcoma aged over 41 based on the bone tumor registry in Japan
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
5 year overall survival
Key secondary outcomes
5 year progression free survival
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 41 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
data from bone tumor registry in Japan, registered in 2006 to 2012
>41 years old
osteosarcoma, undifferentiated high grade pleomorphic sarcoma, dedifferentiated chondrosarcoma, leiomyosarcoma, hemangioendothelioma, fibrosarcoma, malignant giant cell tumor, clear cell chondrosarcoma, undifferentiated sarcoma, hemangiopericytoma, liposarcoma, and malignant mesenthelioma
Key exclusion criteria
<41 years old
low grade malignancy
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihito Nagano |
Organization
Gifu Graduate University School of Medicine
Division name
The department of Orthopaedic Surgery
Zip code
Address
1-1 Yanagido, Gifu
TEL
058-230-6333
a-nagano@lucky.odn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihito Nagano |
Organization
Gifu Gfraduate University school of medicine
Division name
The department of Orthopaedic surgery
Zip code
Address
1-1 Yanagido, Gifu
TEL
058-230-6333
Homepage URL
a-nagano@lucky.odn.ne.jp
Sponsor or person
Institute
Gifu Gfraduate University school of medicine
Institute
Department
Personal name
Funding Source
Organization
Gifu Gfraduate University school of medicine
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
| 2016 | Year | 07 | Month | 10 | 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
| 2015 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
data to be collected are as follows:
age, sex, date of diagnosis, location, TNM classification, Enneking classification, operation, margin, dete of operation, chemotherapy, agents, radiation therapy, local recurrence, distant metastasis, outcome, limb sparing
Management information
Registered date
| 2016 | Year | 07 | Month | 09 | Day |
Last modified on
| 2018 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026609
