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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000037502
Receipt No. R000042747
Scientific Title Clinicopahological characteristics of retroperitoneal liposarcoma: Benefit of surgery for recurrence
Date of disclosure of the study information 2019/07/26
Last modified on 2020/08/04

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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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