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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000023089
Receipt No. 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

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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
Email 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
Email a-nagano@lucky.odn.ne.jp

Sponsor
Institute Gifu Gfraduate University school of medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026609

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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