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)

UMIN ID: C000000093

Registered date:30/08/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: T2-T4aN0M0 invasive bladder cancer
• Date of first enrollment: 2003/06/01
• Target sample size: 360
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: overall survival
• Secondary Outcome: non-progression survival, postoperative morbidity, adverse events of chemotharapy, rate of non-pathological residual disease of the bladder, and QOL

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Japan Clinical Oncology Group(JCOG)
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare