Comparative study of neoadjuvant MVAC chemotharapy plus radical systectomy with radical cystectomy alone for imparovent of survival of patients with invasive bladder cancer (T2-4aN0M0)(JCOG0209, BC MVAC Phase III)

Comparative study of neoadjuvant MVAC chemotharapy plus radical systectomy with radical cystectomy alone for imparovent of survival of patients with invasive bladder cancer (T2-4aN0M0)(JCOG0209, BC MVAC Phase III) - Comparative study of neoadjuvant MVAC chemotharapy plus radical systectomy with radical cystectomy alone for imparovent of survival of patients with invasive bladder cancer (T2-4aN0M0)(JCOG0209, BC MVAC Phase III)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000093

Enrollment

360

Registered

2005-08-30

Start date

2003-06-01

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

T2-T4aN0M0 invasive bladder cancer

Interventions

A:radical cystectomy alone B:neoadjuvant MVAC chemotharapy + radical cystectomy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) T2-T4aN0M0 invasive bladder cancer without prostatic stromal invasion that satisfied all the criteria shown below(1)invasive urothelial cancer with definite muscle-invasion or more extention that is clearly proven with pathological examination of TUR specimens (2)both lymph node nd distant metastases with image diagnosis (N0M0) 2) No simultaneous diagnosis or suspision of urothelial cancer in the urinary tract other than the bladder at the time of initial diagnosis of invasiv bladder cancer 3) No previous treatment for invasive bladder cancer 4) No previous surgery (other than TUR-Bt), systemic or intra-arterial chemotherapy or radiation for superficial bladder cancer 5) No previous chemotherapy or radiation for other cancers or diseases 6) No previous history of urothelial cancer other than superfical bladder cancer 7) No later than 8 weeks after TUR-Bt 8) patients with 20 years old or older, or 75 years old or youger 9) patients with PS 0-1 10) adewuate preservation of organ function 11) written informed consent provided

Exclusion criteria

Exclusion criteria: patients who meet one of criteria below are excluded. 1) active cancer simultaneously occurred in organs other than the urinary tract 2) women who are pregnant, possibly pregnant or lactating 3) patients with psychological disorders or symptoms 4) patients who has recived systemic steroid treatment 5) serious comorbiditirs IHD or arrythemia that should be reated history of myocarddial infarction occured within 6 months liver cirrhosis interstitial pneumonitis, pulmonary fibrosis, or repiratory diseases needing O2 inhalation uncontrolable diabetes 6) patients inapprppriate for the study entry determined by a doctor

Design outcomes

Primary

Measure	Time frame
overall survival	—

Secondary

Measure	Time frame
non-progression survival, postoperative morbidity, adverse events of chemotharapy, rate of non-pathological residual disease of the bladder, and QOL	—

Countries

Japan

Contacts

Public ContactNaoya Masumori, MD

JCOG0209 Coordinating Office Department of Urology, Sapporo Medical University School of Medicine

JCOG_sir@ml.jcog.jp

Outcome results

None listed

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