Phase I/II trial of neoadjuvant intravenous gemcitabine plus intra-arterial cisplatin in muscle-invasive bladder cancer.

Phase I/II trial of neoadjuvant intravenous gemcitabine plus intra-arterial cisplatin in muscle-invasive bladder cancer. - Phase I/II trial of neoadjuvant intravenous gemcitabine plus intra-arterial cisplatin in muscle-invasive bladder cancer.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013636

Enrollment

Registered

2014-04-04

Start date

2014-04-07

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

bladder cancer

Interventions

level1 gemcitabine100mg/m2 IV day1,8,15 ciaplatin 70mg/m2 IA day2 q28days 3cycles level2 gemcitabine 100mg/m2 IV day1,8,15 ciaplatin 100mg/m2 IA day2 q28days 3cycles If feasibility of leve

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed muscle invasive bladder cancer (except for small cell carcinoma) 2. Stage(UICC-TNM): pT2a or 2b N0 M0, stage2 pT3a or 3b or 4 N0 M0, stage3 anyT N1orN2 M0, stage4 3. Age: 20 to 80 4. PS (ECOG) 0-1 5.Diagnosised by transurethral resection of bladder tumour (TURBT) and no previous treatment other than TURBT for invasive bladder cancer. 6. No previous surgery (other than TURBT), systemic or intra-arterial chemotherapy or radiation for superficial bladder cancer. 7. Required Initial Laboratory Values: white blood cell count=>4000 cells/mm3 or Absolute neutrophil count=>1500 cells/mm3 Platelets=>100,000 cells/mm3 Aspartate transaminase (AST) and alanine transaminase (ALT) =<1.5 x ULN for the institution or60IU/L Bilirubin =<1.5 mg/dL Alkaline phosphatase=<2.5 x ULN for the institution Serum creatinine=<1.5 mg/dL EKG: normal or minor changes NYHA class1 8. written informed consent provided

Exclusion criteria

Exclusion criteria: 1. women who are pregnant, possibly pregnant or lactating 2.pleural effusion, peritoneal effusion or pericardial effusion which need emergency treatment 3.presence of active infection 4.presence of active double cancer 5.history of drug hypersensitivity reaction 6.presence of severe complication 7.presence of bilateral hydronephrosis (other than the case which was treated by ureteral stent or nephrostomy ) 8.patients inapprppriate for the study entry determined by a doctor

Design outcomes

Primary

Measure	Time frame
pathological complete response rate	—

Secondary

Measure	Time frame
clinical response rate progression free survival overall survival bladder preservation rate adverse drug reaction	—

Countries

Japan

Contacts

Public ContactHitomi Sakai

Nippon Medical School Musashokosugi Hospital Department of Medical Oncology

hitomisakai@nms.ac.jp044-733-5181

Outcome results

None listed

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