UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041273
Receipt number R000047138
Scientific Title A randomized control trial of fluorescence cystoscopy-assisted en bloc transurethral resection and conventional transurethral resection in patients with non-muscle invasive bladder cancer
Date of disclosure of the study information 2020/08/01
Last modified on 2023/08/03 13:03:10

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Basic information

Public title

A randomized control trial of fluorescence cystoscopy-assisted en bloc transurethral resection and conventional transurethral resection in patients with non-muscle invasive bladder cancer

Acronym

FLEBER study

Scientific Title

A randomized control trial of fluorescence cystoscopy-assisted en bloc transurethral resection and conventional transurethral resection in patients with non-muscle invasive bladder cancer

Scientific Title:Acronym

FLEBER study

Region

Japan


Condition

Condition

Non-muscle invasive bladder cancer

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The evaluation of clinical efficacy and safety of fluorescence cystoscopy-assisted en bloc transurethral resection in patients with non-muscle invasive bladder cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase III


Assessment

Primary outcomes

Two-year recurrence-free rate

Key secondary outcomes

1) Recurrence-free survival
2) Progression-free survival and progression-free rate (Progression: Ta to T1 or muscle-invasive disease)
3) Upper urinary tract cancer-free survival
4) Metastasis-free survival
5) Cancer-specific survival
6) Overall survival
7) Operation time
8) Postoperative change of blood hemoglobin level
9) Pathological complete resection rate
10) Postoperative change of urinary frequency at 1, 3, and 6 months after transurethral resection (evaluation with frequency volume chart)
11) Rate of adverse events (evaluation with CTCAE ver 5)
12) Postoperative change of health-related quality of life (evaluation with SF-8, EORTC QLQ-C30, and FACT-BL)
13) Postoperative change of lower urinary tract symptoms (evaluation with IPSS and OABSS)
14) Postoperative pain (evaluation with NPRS, VAS, and FAS)
15) Operative scar at 3 and 6 months after transurethral resection (evaluation with cystoscopy)
16) Influence of tumor location (trigon, posterior wall, dome, anterior wall, right wall, left wall, and bladder neck) in primary and secondary endpoints


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Fluorescence cystoscopy-assisted en bloc transurethral resection

Interventions/Control_2

Fluorescence cystoscopy-assisted conventional transurethral resection

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

85 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Patients undergoing fluorescence cystoscopy-assisted transurethral resection of bladder tumor and the tumor size (longer diameter) is 6 mm to 30 mm. In patients with multiple tumors, the largest tumor is evaluated.
2) Clinical stage, TaN0M0 or T1N0M0
3) ECOG-Performance Status : 0 to 2
4) Age, 20 to 85 yo
5) Sufficient bone marrow function and organ functions within 60 days before the registration

Key exclusion criteria

1) Suspected of having carcinoma in situ (CIS)
2) History of allergic reaction to 5-aminolevulinic acid
3) Patients with clinically significant liver dysfucntion and liver inflammation
4) Patients with porphyria
5) Patients who can not agree with enrollment of the study by his/her own intention
6) Inappropriate for the enrolment by the judgement of the physician

Target sample size

160


Research contact person

Name of lead principal investigator

1st name Makito
Middle name
Last name Miyake

Organization

Nara Medical University

Division name

Urology

Zip code

6348522

Address

840 Shijo-cho, Kashihara, Nara, Japan

TEL

0744-22-3051

Email

makitomiyake@naramed-u.ac.jp


Public contact

Name of contact person

1st name Makito
Middle name
Last name Miyake

Organization

Nara Medical University

Division name

Urology

Zip code

6348522

Address

840 Shijo-cho, Kashihara, Nara, Japan

TEL

0744-22-3051

Homepage URL

http://www.naramed-u.ac.jp/~urol/about/theme.html

Email

urology@naramed-u.ac.jp


Sponsor or person

Institute

Nara Medical University

Institute

Department

Personal name



Funding Source

Organization

Not applicable

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Institute of Clinical and Translational Science, Nara Medical University

Address

840 Shijo-cho, Kashihara, Nara, Japan

Tel

0744-22-3051

Email

ethics_nara@naramed-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

2020 Year 08 Month 01 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

Enrolling by invitation

Date of protocol fixation

2020 Year 07 Month 31 Day

Date of IRB

2020 Year 07 Month 31 Day

Anticipated trial start date

2020 Year 08 Month 03 Day

Last follow-up date

2027 Year 07 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

2020 Year 08 Month 01 Day

Last modified on

2023 Year 08 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047138


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name