Organ-preserved tetra-modality therapy for patient having muscle invasive urothelial carcinoma 'OMC-regimen'
Phase 2
Recruiting
- Conditions
- Muscle invasive bladder carcinoma (MIBC) including regional lymph node metastasis
- Registration Number
- JPRN-UMIN000012968
- Lead Sponsor
- Osaka medical college, Department of urology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 500
Inclusion Criteria
Not provided
Exclusion Criteria
Epidermoid carcinoma or adenocarcinoma Distance metastases or extrapelvic node positivity Severe digestive history (ulcerative colitis, complicated diverticulitis) Pregnancy and breast feeding
Study & Design
- Study Type
- Interventional,observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Disease-free surviva: The time to relapse is defined as the time from the date of randomization to the date of the first event. Time to relapse for patients without any event (local, regional, distance, or death) will be censored at the date of latest information. 2. CR inductivity rate assessed histologically applying TURBT three months after the treatment sequence as well as computed tomography to evaluate metastasis.
- Secondary Outcome Measures
Name Time Method 1. Overall survival:the time to death is defined as time from the randomization to the date of death from any cause, or to the date on which latest information is obtained. 2. •Acute and late toxicities: acute and late toxicities will be scored according to the NCI-CTC v4.0. 3. •Quality of life using questionnaires (i.e. IPSS, OABSS, IIEF5,etc)