UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037502 |
|---|---|
| Receipt number | 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 00:33:11 |
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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
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
kenta-i@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042747
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