Efficacy and safety of dose dense MVACarbo chemotherapy for cisplatin-ineligible patients with advanced urothelial cancer

Efficacy and safety of dose dense MVACarbo chemotherapy - CARBUNCLE study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000051737

Enrollment

Registered

2023-08-10

Start date

2023-10-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced urothelial carcinoma: Bladder cancer, renal pelvic cancer, ureteral cancer, urethral cancer

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Objective response rate	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactMakito Miyake

Nara Medical University Urology

makitomiyake@naramed-u.ac.jp0744223051

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026