UMIN-CTR Clinical Trial

Basic information
Public title	Characteristics of retroperitoneal liposarcoma: Surgery for recurrence
Acronym	Characteristics of retroperitoneal liposarcoma
Scientific Title	Clinicopahological characteristics of retroperitoneal liposarcoma: Benefit of surgery for recurrence
Scientific Title:Acronym	Clinicopahological characteristics of retroperitoneal liposarcoma
Region	Japan

Condition
Condition	Retroperitoneal liposarcoma
Classification by specialty	Surgery in general
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To describe clinicopathological characteristics of primary and recurrent retroperitoneal liposarcoma.
Basic objectives2	Others
Basic objectives -Others	descriptive and exploratory study
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Overall survival Recurrence free survival
Key secondary outcomes

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who admitted to Nagoya University hospital between January 2005 and December 2018 and were diagnosed as having reteroperitoneal liposarcoma
Key exclusion criteria	Patients whose age was less than 20 years when this study strated
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Yukihiro Middle name Last name Yokoyama
Organization	Nagoya University Graduate School of Medicine
Division name	Perioperative medicine
Zip code	466-8560
Address	65 Tsurumai-cho Showa-ku Nagoya Aichi
TEL	052-744-2222
Email	yyoko@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Kenta Middle name Last name Ishii
Organization	Nagoya University Graduate School of Medicine
Division name	Surgical Oncology
Zip code	466-8560
Address	65 Tsurumai-cho Showa-ku Nagoya Aichi
TEL	052-744-2222
Homepage URL
Email	kenta-i@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Self funding
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	Ethics Committee of Nagoya University Graduate School of Medicine
Address	65 Tsurumai-cho Showa-ku Nagoya Aichi
Tel	052-744-2061
Email	ethics@med.nagoya-u.ac.jp

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	2019 Year 07 Month 26 Day

Related information
URL releasing protocol	https://academic.oup.com/jjco/article/doi/10.1093/jjco/hyaa126/5874834
Publication of results	Published

Result
URL related to results and publications	https://academic.oup.com/jjco/article/doi/10.1093/jjco/hyaa126/5874834
Number of participants that the trial has enrolled	52
Results	The patients undergoing R0 resection had significantly higher recurrence-free survival rates than the patients undergoing non-R0 resection.(p=0.033) The recurrence rates were 65, 67, 73 and 100% after the first, second, third and fourth surgeries. The 5-year overall survival rates were 82, 69, 40 and 0% after the first, second, third and fourth surgeries.
Results date posted	2020 Year 08 Month 04 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2020 Year 07 Month 23 Day
Baseline Characteristics	Fifty-two patients with retroperitoneal liposarcoma were analysed. Among them, 46 patients had undergone surgery. Histologic grades included well-differentiated (n=21), dedifferentiated (n=21), myxoid (n=3) and pleomorphic (n=1). The median age was 61 years, and 29 patients (56%) were male.
Participant flow	Fifty-two patients with primary retroperitoneal liposarcoma were analysed. Amongst them, 46 patients (88%) had undergone surgery.
Adverse events	None
Outcome measures	3-year recurrence-free survival, 5-year recurrence-free survival, 5-year overall survival, 10-year overall survival
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2019 Year 04 Month 17 Day
Date of IRB	2019 Year 05 Month 29 Day
Anticipated trial start date	2019 Year 06 Month 01 Day
Last follow-up date	2019 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	A total of 52 patients with retroperitoneal liposarcoma were analyzed. The associations between clinicopathological factors and OS/RFS were investigated.

Management information
Registered date	2019 Year 07 Month 26 Day
Last modified on	2020 Year 08 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042747

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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