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
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
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
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
