Bladder Cancer
Conditions
Brief summary
Effect of adjuvant chemotherapy to control tumor progression in patients after cystectomy for locally advanced bladder cancer.
Detailed description
Effect of adjuvant chemotherapy based on Gemcitabine and Cisplatin to control tumor progression in patients after cystectomy for locally advanced bladder cancer.
Interventions
Gemcitabine 1000 mg/m2 iv,D1,D8,D15;cisplatin 70 mg/m2 iv,D2.With 4 cycles. Treatment begins between 1-5 weeks after radical operation (within 42 days is recommended)
Sponsors
Southwest Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female, 18 years of age or older, estimated life expectancy ≥ 6 months. 2. Pathologically confirmed localized invasive bladder cancer following standardize radical cystectomy and pelvic lymphadenectomy. 3. Transitional cell carcinoma of bladder, stage pT3N0M0.Transitional cell carcinoma may be with or without squamous cell carcinoma and/or adenocarcinoma components. 4. Electrocorticography(ECOG) performance status 0-2. 5. Blood routine:Absolute neutrophil count (ANC) ≥ 1500/μL,White blood cell count ≥ 3000/μLPlatelets ≥ 100,000/μL,Hemoglobin ≥ 10.0 g/dL, 6. Total serum bilirubin≤ 1.5 x upper limit of normal (ULN).Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase(SGOT)) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase (SGPT)) ≤ 2.5 x upper limit of normal (ULN). 7. Creatinine clearance rate,Ccr ≥ 60% 8. ECG：no arrhythmias, no myocardial infarction. * Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment. * Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests,and other study procedures.
Exclusion criteria
1. Past history of systemic chemotherapy 2. Serious heart and lung dysfunction. 3. Associated with central or peripheral neuropathy greater than 2 grade. 4. Evidence of distant metastasis beyond the pelvis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| cancer progressive free survival rate | 60 months |
Secondary
| Measure | Time frame |
|---|---|
| overall survival | 60 months |
Countries
China
Outcome results
None listed