UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006363
Receipt number R000007553
Scientific Title Bladder preservation therapy with GC radiation against invasive bladder cancer.
Date of disclosure of the study information 2011/09/16
Last modified on 2023/09/25 20:52:32

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Basic information

Public title

Bladder preservation therapy with GC radiation against invasive bladder cancer.

Acronym

Bladder preservation therapy with GC radiation against invasive bladder cancer.

Scientific Title

Bladder preservation therapy with GC radiation against invasive bladder cancer.

Scientific Title:Acronym

Bladder preservation therapy with GC radiation against invasive bladder cancer.

Region

Japan


Condition

Condition

Muscle-invasive bladder cancer

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To confirm the efficacy and safety of bladder preserving therapy using GC radiation compared with radical cystectomy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Recurrence-free survival rate

Key secondary outcomes

Disease-specific survival rate
Overall survival rate
Incidence of adverse events


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine Maneuver

Interventions/Control_1

radiation combined with gemcitabine and cisplatin.

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 have MIBC and strong desire for keeping their bladder.

Key exclusion criteria

1 Patients who have contraindication against gemcitabine and/or cisplatin.
2 Patients who received previous irradiation to pelvis.
3 Others, patients who have unsuitable condition.

Target sample size

38


Research contact person

Name of lead principal investigator

1st name Hideyasu
Middle name
Last name Matsuyama

Organization

Department of Urology, Yamaguchi University, School of Medicine

Division name

Department of Urology

Zip code

755-8505

Address

Minamikogushi 1-1-1, Ube, Yamaguchi, Japan

TEL

0836-22-2275

Email

hidde@yamaguchi-u.ac.jp


Public contact

Name of contact person

1st name Matsumoto
Middle name
Last name Hiroaki

Organization

Yamaguchi University, School of Medicine

Division name

Department of Urology

Zip code

755-8505

Address

Minamikogushi 1-1-1, Ube, Yamaguchi, Japan

TEL

0836-22-2275

Homepage URL


Email

hmatsumo@yamaguchi-u.ac.jp


Sponsor or person

Institute

Department of Urology, Yamaguchi University, School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Urology, Yamaguchi University, School of Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Institutional Review Board

Address

1-1-1, Minami-Kogushi, Ube, Yamaguchi

Tel

0836-22-2428

Email

me223@yamaguchi-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

山口大学医学部附属病院
Department of Urology, Yamaguchi University, School of Medicine


Other administrative information

Date of disclosure of the study information

2011 Year 09 Month 16 Day


Related information

URL releasing protocol

https://doi.org/10.1093/jjco/hyac095

Publication of results

Published


Result

URL related to results and publications

https://doi.org/10.1093/jjco/hyac095

Number of participants that the trial has enrolled

38

Results

Chemoradiotherapy using gemcitabine and cisplatin for muscle-invasive bladder cancer is effective for local cancer control and shows no significant difference in oncological prognosis compared with radical cystectomy.

Results date posted

2023 Year 09 Month 25 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Patients diagnosed with muscle-invasive bladder cancer by transurethral resection of bladder tumor and who wished for bladder preservation were recruited.

Participant flow

The regimens were gemcitabine 300 mg/m2 and cisplatin 30 mg/m2 in day 1 and concomitant irradiation 1.8 Gy/Fr, five fractions per week. Irradiation was administered to the true pelvis up to 36 Gy and was then boosted to the entire bladder until a total of 54 Gy. Transurethral resection of bladder tumor was also performed after chemoradiotherapy to evaluate pathological response to treatment. We evaluated treatment efficacy and survival, safety of chemoradiotherapy with gemcitabine and cisplatin.

Adverse events

Patients were able to receive 3 to 5 cycle GC radiation and any grade 3 or more adverse event was 7 (18.4%) cases.
No treatment related death was recorded.

Outcome measures

Thirty-eight patients were enrolled, and three patients were excluded. Pathological complete response after chemoradiotherapy was observed in 31 patients, and the 5-year bladder-intact metastasis-free survival rate was 76%. The 5-year cancer-specific and overall survival rates for chemoradiotherapy were 85 and 75%, respectively, which were not significantly different from those for radical cystectomy (73 and 71%, respectively). Grade 3/4 adverse events included neutropenia (63%), anemia (18%) and thrombocytopenia (37%); however, treatment-related deaths were not observed.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2011 Year 10 Month 01 Day

Date of IRB

2011 Year 10 Month 26 Day

Anticipated trial start date

2011 Year 10 Month 01 Day

Last follow-up date

2018 Year 09 Month 30 Day

Date of closure to data entry

2019 Year 09 Month 30 Day

Date trial data considered complete

2019 Year 12 Month 31 Day

Date analysis concluded

2022 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2011 Year 09 Month 16 Day

Last modified on

2023 Year 09 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007553


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name