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

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 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


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

Value
https://center6.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