Bladder Cancer Clinical Trial
Official title:
Adjuvant Intraarterial Chemotherapy Following Surgery in Treating Patients With Locally Advanced Bladder Cancer
Effect of adjuvant intra-arterial chemotherapy to control tumor progression in patients cystectomized for locally advanced bladder cancer.
Status | Recruiting |
Enrollment | 212 |
Est. completion date | December 2021 |
Est. primary completion date | April 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Pathologically confirmed localized invasive bladder cancer following standardize radical cystectomy. - Transitional cell carcinoma of bladder, stage pT3-4,N1-3,M0.Transitional cell carcinoma may be with or without squamous cell carcinoma and/or adenocarcinoma components. - Male or female, 18 years of age or older, estimated life expectancy = 6 months. - ECOG performance status 0 or 1. - 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).Total serum bilirubin= 1.5 x upper limit of normal (ULN). - Absolute neutrophil count (ANC) = 1500/µL - Platelets = 75,000/µL - Hemoglobin = 8.0 g/dL - White blood cell count = 3500/µL - Creatinine clearance rate,Ccr = 40ml/min - Cardiac function level 0~2. - 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: - Bladder cancer without any transitional cell carcinoma component,such as adenocarcinoma,squamous cell carcinoma,small cell carcinoma - Evidence of distant metastasis beyond the pelvis. - No definitely pathological stage,such as no pathologic examination of perivesical fat,unable to differentiate pT2 and pT3,not performing lymph node dissection or regional lymph nodes cannot be assessed as the dissected lymph node number is less than ten. - Prior neoadjuvant chemotherapy (systemic or intra-arterial) three months preoperatively, not including intra-vesical infusion chemotherapy. - Prior pelvic radiation therapy dosage = 30Gy six months preoperatively. - Serious liver and kidney dysfunction. - Accompanied with other serious diseases. - Severe/unstable angina, arrhythmia,symptomatic heart failure, hypertension that cannot be controlled by medications and 6 months for myocardial infarction. - Non-compliance of regular follow-up due to psychological, social, family and geographical and other reasons. |
Country | Name | City | State |
---|---|---|---|
China | Cancer Center, Sun Yat-sen University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-sen University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | cancer progressive free survival rate | 60 months | ||
Secondary | overall survival | 60 months | ||
Secondary | Cancer specific survival | 60 months | ||
Secondary | Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 12 months |
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