Multi-institutional clinical phaseII trial of neoadjuvant chemotherapy with gemcitabine and cisplatin in patients with invasive urothelial carcinoma of the urinary bladder

Multi-institutional clinical phaseII trial of neoadjuvant chemotherapy with gemcitabine and cisplatin in patients with invasive urothelial carcinoma of the urinary bladder - Neoadjuvant chemotherapy with gemcitabine and cisplatin for invasive bladder urothelial carcinoma

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003738

Enrollment

Registered

2010-07-01

Start date

2010-06-01

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

Muscle-invasive bladder cancer

Interventions

3 cycles of cisplatin at 70 mg/m2 on day2,and gemcitabine at 1000mg/m2 on Day 1, 8,15 before radical cystectomy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Histologically confirmed muscle invasive transitional cell carcinoma of the bladder. 2)Clinical stage T2-T4a N0/X M0 disease.Medically appropriate candidate for radical cystectomy. 3)ECOG Performance Status 0-1. 4)No prior therapy(systemic chemotherapy, surgery, radiation, immunotherapy) 5)No previous history or concomitance of upper urinary tract cancer 6)Required Initial Laboratory Values: 7)Life expectancy > 3 months 8)Sign informed consent of this trial

Exclusion criteria

Exclusion criteria: 1)Serious active infection 2)Temperature(<38) 3)Serious intercurrent medical or psychiatric illness 4)Prior malignancy [the patient has been disease free under 5 years] 5)Brain metastasis 6)Pleural effusion or ascites 7)Pericardial effusion 8)Varicella 9)peripheral neuropathy 10)Drug allergy or Pre-existing 11)If female of childbearing potential, pregnancy test is possitive 12)Others; based on the physicians' judgement

Design outcomes

Primary

Measure	Time frame
Response rate of neoadjuvant GC(GEM+CDDP)chemotherpy in patients with invasive bladder cancer	—

Secondary

Measure	Time frame
Safety, Overall survival period, Cancer-specific survival period, Progression-free survival period	—

Countries

Japan

Contacts

Public ContactKiyohide Fujimoto

Nara Medical University Department of Urology

0744-22-3051

Outcome results

None listed

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