UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051737 |
|---|---|
| Receipt number | R000059050 |
| Scientific Title | Efficacy and safety of dose dense MVACarbo chemotherapy |
| Date of disclosure of the study information | 2023/08/10 |
| Last modified on | 2023/07/28 15:00:33 |
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Basic information
Public title
Efficacy and safety of dose dense MVACarbo chemotherapy for cisplatin-ineligible patients with advanced urothelial cancer
Acronym
CARBUNCLE study
Scientific Title
Efficacy and safety of dose dense MVACarbo chemotherapy
Scientific Title:Acronym
CARBUNCLE study
Region
| Japan |
Condition
Condition
Advanced urothelial carcinoma: Bladder cancer, renal pelvic cancer, ureteral cancer, urethral cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine Efficacy and safety of dose dense MVACarbo chemotherapy for cisplatin-ineligible patients with advanced urothelial cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Objective response rate
Key secondary outcomes
1) Disease control rate
2) Completion rate of 4 cycles of DD-MVACarbo and number of cycles of DD-MVACarbo
3) The safety of DD-MVACarbo: adverse events evaluated with CTCAE v5.0
4) Health-related quality of life questionnaire survey: EORTC-QLQ-C30, EQ-5D-5L, FACT-G, Pittsburgh sleep quality index, CiTAS
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Combination chemotherapy with four anticancer agents, 14 days per one cycle, total 4 cycles
Methotrexate 15 mg/m2 day 1
Vinblastine 3 mg/m2 day 2
Doxorubicin 30 mg/m2 day 2
Carboplatin AUC 4-5 (mg/body) day 2
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients having at least one of advanced bladder cancer, renal pelvic cancer, ureteral cancer, urethral cancer
2) Patients having at least one lesion measurable with RECIST v1.1
3) Age, 20 to 85 years-old
4) No treatment history of systemic chemotherapy for advanced urothelial carcinoma
5) Patients having at least one of factors listed below:
Glomerular filtration rate (GFR): 30 or more and <60 mL/min/1.73m2
ECOG-Performance Status: 2 or more
Hearing impairment: grade 2 or more
Peripheral neuropathy: grade 2 or more
New York Heart Association classification grade 3 or more
6) Sufficient bone marrow function and organ functions
Key exclusion criteria
1) Patients who cannot agree with enrollment of the study by his/her own intention
2) Inappropriate for the enrolment by the judgement of the physician
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Makito |
| Middle name | |
| Last name | Miyake |
Organization
Nara Medical Universtiy Hospital
Division name
Urology
Zip code
634-8522
Address
840 Shijo-cho, Kashihara, Nara
TEL
0744223051
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
634-8522
Address
840 Shijo-cho, Kashihara, Nara
TEL
0744223051
Homepage URL
makitomiyake@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Miyake Makito
Funding Source
Organization
Nara Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Urology, Nara Prefectural Seiwa Medical Center
Urology, Yamato Takada Municipal Hospital
Urology, Takai Hospital
Urology, Saiseikai Chuwa Hospital
Urology, Matusaka Chuo General Hospital
Urology, Tane General Hospital
Urology, Nara City Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nara Medical University Ethics Committee
Address
840 Shijo-cho, Kashihara, Nara
Tel
0744223051
ino_rinri@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
| 2023 | Year | 08 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 08 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 07 | Month | 28 | Day |
Last modified on
| 2023 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059050
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