NIPH Clinical Trials Search

UMIN ID: C000000093

Registered date:30/08/2005

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)

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedT2-T4aN0M0 invasive bladder cancer
Date of first enrollment2003/06/01
Target sample size360
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)A:radical cystectomy alone B:neoadjuvant MVAC chemotharapy + radical cystectomy


Primary Outcomeoverall survival
Secondary Outcomenon-progression survival, postoperative morbidity, adverse events of chemotharapy, rate of non-pathological residual disease of the bladder, and QOL

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
GenderMale and Female
Include criteria
Exclude criteriapatients 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


public contact
Name Naoya Masumori, MD
Address Minami-1Jo, Nishi-16, Chuo-Ku, Sapporo 060-8543,JAPAN Japan
Affiliation JCOG0209 Coordinating Office Department of Urology, Sapporo Medical University School of Medicine
scientific contact
Name Taiji Tsukamoto, MD, D.Med.Sci
Address Minami-1Jo, Nishi-16, Chuo-Ku, Sapporo 060-8543,JAPAN Japan
Affiliation Sapporo Medical University School of Medicine Department of Urology