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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020506
Receipt No. 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 2020/07/12

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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
Email 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/
Email narishin@doc.med.akita-u.ac.jp

Sponsor
Institute Department of Urology, Akita University Graduate School of Medicine
Institute
Department

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
Email 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(広島県)、北里大学医学部附属病院(神奈川県)、平鹿総合病院(秋田県)、秋田厚生医療センター(秋田県)

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
2027 Year 12 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
2020 Year 07 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023645

Research Plan
Registered date File name
2016/05/02 LYNUC study 研究計画書決定.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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