UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	chemotherapy for primary bone sarcoma over 41 except for Ewing sarcoma
Title of the study (Brief title)	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	Akihito Nagano
Organization	Gifu Graduate University School of Medicine
Division name	The department of Orthopaedic Surgery
Address	1-1 Yanagido, Gifu
TEL	058-230-6333
Email	a-nagano@lucky.odn.ne.jp

Public contact
Name of contact person	Akihito Nagano
Organization	Gifu Gfraduate University school of medicine
Division name	The department of Orthopaedic surgery
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 12 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000026609