UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical outcome of pazopanib in Japanese patients with soft tissue sarcoma; Multicenter study
Title of the study (Brief title)	Clinical outcome of pazopanib in Japanese patients with soft tissue sarcoma;Multicenter study
Region	Japan

Condition
Condition	Malignant soft tissue tumor
Classification by specialty	Orthopedics
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim is to evaluate the safety and efficacy of pazopanib in patients with soft tissue sarcoma
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Survival Progressive-free survival Side effect
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients inclusion 1.Clinical history of treatment for primary soft tissue sarcoma 2.The aim to use pazopanib is for local recurrent or metastatic tumor 3.The existence of tumors which can be evaluated by radiological examination when treatment using pazopanib is started.
Key exclusion criteria	Patients who are not treated in the registered institutions of Japanese Musculoskeletal Oncology Group will be excluded from this study.
Target sample size	200

Research contact person
Name of lead principal investigator	Dr Akihiko Matsumine
Organization	Mie University Graduate School of Medicine
Division name	Dept. of Orthopaedic Surgery
Address	Edobashi 2-174,Tsu-city, Mie, Japan
TEL	059-231-5022
Email	matsumin@clin.medic.mie-u.ac.jp

Public contact
Name of contact person	Dr. Tomoki Nakamura
Organization	Mie University Graduate School of Medicine
Division name	Dept. of Orthopaedic Surgery
Address	Edobashi 2-174, Tsu-city, Mie, Japan
TEL	059-232-1111
Homepage URL
Email	tomoki66@clin.medic.mie-u.ac.jp

Sponsor
Institute	Japanese Musculoskeletal Oncology Group
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Japanese Musculoskeletal Oncology Group
Organization
Division
Category of Funding Organization	Other
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	2013 Year 12 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 07 Month 12 Day
Anticipated trial start date	2013 Year 12 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete	2015 Year 07 Month 31 Day
Date analysis concluded	2015 Year 12 Month 03 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	We retrospectively evaluate the safety, survival and progressive-free survival in patients with maligant soft tisseu tumor one years after administration of pazopanib.

Management information
Registered date	2013 Year 12 Month 12 Day
Last modified on	2016 Year 06 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014695