UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020506 |
|---|---|
| Receipt number | R000023645 |
| Scientific Title | A multi-institutional prospective randomized controlled study investigating the outcome and safety of the lymphadenectomy plus radical nephroureterectomy for upper tract urothelial cancer |
| Date of disclosure of the study information | 2016/01/08 |
| Last modified on | 2022/07/15 20:55:30 |
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Basic information
Public title
A multi-institutional prospective randomized controlled study investigating the outcome and safety of the lymphadenectomy plus radical nephroureterectomy for upper tract urothelial cancer
Acronym
LYNUC study
Scientific Title
A multi-institutional prospective randomized controlled study investigating the outcome and safety of the lymphadenectomy plus radical nephroureterectomy for upper tract urothelial cancer
Scientific Title:Acronym
LYNUC study
Region
| Japan |
Condition
Condition
Upper tract urothelial carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the outcome, safety and validity of lymphadenectomy in the procedure of radical nephroureterectomy for patients with upper tract urothelial carcinoma located in renal pelvis or upper ureter proximal to the lower renal pole level without lymph node metastasis by preoperative imaging studies.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
5-year recurrence-free survival
Key secondary outcomes
5-year overall survival,
5-year cancer-specific survival,
location of recurrences,
perioperative complications
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Intervention Group:
In addition to standard open or laparoscopic radical nephroureterectomy, regional lymphadenectomy of the area defined as follows will be performed.
Left: Left side of the para-aortic area (from the 2 cm-cranial level of the renal artery to the level of the inferior mesenteric artery).
Right: Right side of the para-inferior vena cava area, posterior and anterior inferior vena cava area, and inter-aortocaval area (from the 2 cm-cranial level of the renal vein to the level of the inferior mesenteric artery).
Interventions/Control_2
Control Group:
Standard open or laparoscopic nephroureterectomy will be performed without regional lymph node dissection.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who meet the criteria as described below will be included:
1.Are presenting with an upper tract urothelial carcinoma located in the renal pelvis or ureter proximal to the lower renal pole level without lymph node metastasis that is diagnosed using CT scan and cytology.
2.Are presenting with a curable disease by radical nephroureterectomy.
3.Are presenting with no lymph-node swelling treated by the neo-adjuvant chemotherapies and is diagnosed to be a curable disease by radical nephroureterectomy.
4.Are presenting with an initial diagnosis of urothelial carcinoma.
5.Are presenting with ECOG performance status 0-1.
6.Agree with the protocol with signed informed consent
Key exclusion criteria
Patients who meet the criteria below will be excluded:
1.Are presenting with cTa or cTis tumor.
2.Are presenting with an upper tract urothelial carcinomas located in the ureter distal to the lower renal pole level.
3.Are presenting with cN1 or cN2 disease and lymphadenectomy is strongly recommended.
4.Are presenting with distant metastases.
5.Have histories bladder cancer or have simultaneous bladder cancer.
Target sample size
204
Research contact person
Name of lead principal investigator
| 1st name | Tomonori |
| Middle name | |
| Last name | Habuchi |
Organization
Akita University Graduate School of Medicine
Division name
Urology
Zip code
010-8543
Address
1-1-1, Hondo, Akita, Akita, Japan
TEL
018-884-6156
thabuchi@doc.med.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | Shintaro |
| Middle name | |
| Last name | Narita |
Organization
Akita University Graduate School of Medicine
Division name
Urology
Zip code
010-8543
Address
1-1-1, Hondo, Akita, Akita, Japan
TEL
018-884-6156
Homepage URL
http://www.med.akita-u.ac.jp/~hinyoki/
narishin@doc.med.akita-u.ac.jp
Sponsor or person
Institute
Department of Urology, Akita University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japanese Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Urology, Akita University Graduate School of Medicine
Address
1-1-1 Hondo, Akita
Tel
0188846156
thabuchi@doc.med.akita-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
秋田大学医学部附属病院（秋田県）、呉医療センター・中国がんセンター、安佐市民病院(広島県）、北里大学医学部附属病院（神奈川県）、東邦大学医療センター佐倉病院、帝京大学ちば総合医療センター（千葉県）、獨協医科大学附属病院（栃木県）、山形大学医学部附属病院（山形県）、平鹿総合病院、秋田厚生医療センター、秋田赤十字病院、市立秋田総合病院、大曲厚生医療センター、由利組合総合病院（秋田県）、岩手県立胆沢病院（岩手県）、国際医療福祉大学（千葉）、弘前大学医学部付属病院（青森）、福島県立医科大学付属病院（福島）、岩手県立医科大学附属病院（岩手）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 08 | Day |
Last modified on
| 2022 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023645
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/07/15 | 修正版LYNUC study 研究計画書3.1版_final.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
