CARBUNCLE study

JRCT ID: jRCTs051240026

Registered date:08/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Urothelial carcinoma (bladder cancer, renal pelvic cancer, ureteral cancer, urethral cancer)
• Date of first enrollment: 08/05/2024
• Target sample size: 46
• Study type: Interventional
• Intervention(s): 14 days per one cycle. 15 mg/m2 of methotrexate on day 1 and 3 mg/m2 of vinblastine, 30 mg/m2 of doxorubicin, and 3 mg/m2 of vinblastine, and AUC x (GFR + 25) mg of carboplatin on day 2. AUC ranges from 4 to 5.

Outcome(s)

• Primary Outcome: Objective Response Rate

Secondary Outcome

1) Disease Control Rate
2) Complete rate of 4 cycles of DD-MVAC and number of treated cycles
3) Treatment-induced changes in questionnaires regarding health-related quality of life, evaluation with EORTC-QLQ-C30, EQ-5D-5L, FACT-G, Pittsburgh Sleep Quality Index, and Chemotherapy Induced Taste Alteration Scale

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

1) Patients with at least one of bladder cancer, renal pelvic caner, ureteral cancer, and urethral cancer
2) Patients with at least one evaluable target lesion according to RECIST v1.1 (primary lesion or metastatic lesion)
3) Age, 20 to 80 years-old
4) Patients without treatment history of any platinum-based chemotherapy
5) Patients who meet at least one of cisplatin-ineligible criteria
- eGFR, 30 mL/min or more and 60 mL/min or less
- ECOG-performance status, 2 or more
- CTCAE ver 5.0, hearing impaired, grade 2 or more
- CTCAE ver 5.0, neuropathy, grade 2 or more
- New York Heart Association Class III or IV heart failure
6) Bone marrow function and organ functions are sufficient within 30 days prior to the study registration.
- Hemoglobin 9.0 g/dL or more
- White blood cell count, 3000 /mm3 or more and 12,000 /mm3 or less
- Neutrophil count, 1,500 /mm3 or more
- Platelet count, 100,000 /mm3 or more
- Total bilirubin, 3.0 mg/dL or less
- Aspartate aminotransferase (AST) < 100 IU/L and Alanine aminotransferase (ALT) < 100 IU/L

Exclude criteria

1) Patients who have difficulties in agreeing to participate the trial on his/her own initiative
2) Patients with contraindication of any of anti-cancer drugs used in this trial
3) Inappropriate for the enrolment by the judgement of the principal investigator or the sub-investigators.

Related Information

• Primary Sponsor: Miyake Makito
• Source(s) of Monetary Support: Nara Medical University