NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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

Outcome(s)

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 criteria1) 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
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

Contact

public contact
Name Naoya Masumori, MD
Address Minami-1Jo, Nishi-16, Chuo-Ku, Sapporo 060-8543,JAPAN Japan
Telephone
E-mail JCOG_sir@ml.jcog.jp
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
Telephone
E-mail
Affiliation Sapporo Medical University School of Medicine Department of Urology