UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008173 |
|---|---|
| Receipt number | R000009630 |
| Scientific Title | A randomized comparison study of intravesical mitomycin C versus mitomycin C and cytarabine to prevent recurrences in non-muscle-invasive urothelial carcinoma of the bladder. |
| Date of disclosure of the study information | 2012/06/18 |
| Last modified on | 2024/04/15 21:04:54 |
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Basic information
Public title
A randomized comparison study of intravesical mitomycin C versus mitomycin C and cytarabine to prevent recurrences in non-muscle-invasive urothelial carcinoma of the bladder.
Acronym
A Randomized comparison study of intravesical MMC vs MMC+Ara-C in NMIBC.
Scientific Title
A randomized comparison study of intravesical mitomycin C versus mitomycin C and cytarabine to prevent recurrences in non-muscle-invasive urothelial carcinoma of the bladder.
Scientific Title:Acronym
A Randomized comparison study of intravesical MMC vs MMC+Ara-C in NMIBC.
Region
| Japan |
Condition
Condition
Bladder cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of intravesical mitomycin C and mitomycin C and cytarabine in non-muscle-invasive bladder cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Disease-free survival
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Mitomycin C 30mg
1/week for 6 weeks
Interventions/Control_2
Mitomycin C 30mg+cytarabine 200mg
1/week for 6 weeks
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
Non-muscle invasive bladder cancer that were treated with transurethral resection.
Key exclusion criteria
1) WHO prformance status is 3 or more.
2) Contraindication of drugs.
3) With other maligancy and plan of additional treatment.
4) With disadvantage for patient by outpatinet care.
5) Not include urothelial cancer by hitological diagnosis.
5) Without a written agreement.
6) Under 20 years old.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Sakai |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Nephro-Urology
Zip code
852-8031
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7340
hsakai@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuyoshi |
| Middle name | |
| Last name | Miyata |
Organization
Nagasaki University Hospital
Division name
Urology
Zip code
852-8031
Address
1-7-1 Sakamoto
TEL
095-819-7340
Homepage URL
int.doc.miya@m3.dion.ne.jp
Sponsor or person
Institute
Department of Urology, Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Urology, Nagasaki University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Hospital
Address
1-7-1 Sakamoto, Nagasaki
Tel
095-819-7256
2745@ml.nagasaki-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
| 2012 | Year | 06 | Month | 18 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/34383381/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/34383381/
Number of participants that the trial has enrolled
200
Results
Recurrece-free survival in MMC+Ara-C group (n=81) was longer (P=0.018) than that in MMC group (n=87). Such finding was found in intermeaiate-risk cancer. Urinary pH in MMC+Ara-C group was higher than MMC group (P<0.001), and frequency of a urinary pH of >7.0 in MMC+Ara-C group was higher than MMC one (P<0.001). Multivariate analysis showed incerased urinary pH was associated with better outcomes (HR 0.18, 95%CI 0.18-0.38, P<0.001).
Results date posted
| 2024 | Year | 04 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The eligibility criterion was histologically diagnosed non-muscle invasive bladder cancer (pTis, pTa, or pT1) treated with complete resection. The exclusion criteria were: i) WHO performance status of 3 or less, ii) contraindication of drugs, iii) other malignancies and additional treatment plans, iv) disadvantages for patients due to outpatient care, v) no histological diagnosis of urothelial cancer, vi) no written informed consent, and vii) aged <20 years.
Participant flow
This was a prospective randomised controlled trial conducted between June 2012 and March 2017, and 200 patients with non-muscle inevasive bladder cancer were recruited from six institutes in Japan. After exclusion due to heart failure, pathological diagnosis, choice of BCG therapy, and incomplete data, 79 and 86 participants were treated with MMC and MMC+Ara-C therapy,respectively.
Intravesical therapy was initiated 4-6 weeks after peration, and weekly instillation was scheduled for 6 weeks at a dose of 30 mg MMC in 40 ml physiological saline or 30 mg MMC in 30 ml physiological saline combined with 200 mg/10 ml Ara-C with retention for 1 hour. Cystoscopy and urine cytology were performed every 3 months for the first 3 years, every 6 months for the next 5 years.
Adverse events
There were 14 and 10 adverse events in the MMC and MMC + Ara-C groups, respectively, without a significant difference (P = 0.113). All adverserevents were mild degree.
Outcome measures
The recurrence-free survival, urinary pH, and adverse events
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 06 | Month | 14 | Day |
Date of IRB
| 2012 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2012 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2017 | Year | 03 | 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
| 2012 | Year | 06 | Month | 14 | Day |
Last modified on
| 2024 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009630
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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