Bladder cancer(Urothelium carcinoma)
Conditions
Interventions
Chemotherapy group:cisplatin Intra-arterial Chemotherapy
Control group:THP
Sponsors
Cancer Center, Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: This study can fulfill its objectives only if appropriate subjects are enrolled. The following eligibility criteria are designed to select subjects for whom protocol treatment is considered appropriate. Inclusion Criteria Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study: 1. Localized invasive baldder cancer without metastases within four weeks following Standardize radical cystectomy,and pathologiaclly confirmed tumor and node stage; 2. Pathologic types and stage: urothelium carcinoma of grade level II~III, and pT1-2pN1-2, pT3-4apN0-2; 3. Male or female, 18 years of age or older, and estimated life expectancy of >=6 months; 4. ECOG performance status 0 or 1; 5. Adequate organ function as defined by the following criteria: (1) Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase[SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) <=2.5 * upper limit of normal (ULN); (2) Total serum bilirubin,gama glutamyltransferase, alkaline phosphatase and lactic Dehydrogenase <=upper limit of normal (ULN) ? Absolute neutrophil count (ANC) =2000/µL ? Platelets =100,000/µL ? Hemoglobin =9.0 g/dL ? White blood cell count =3500/µL ? Serum creatinine =1.25 × ULN ? Cardiac function level 0~2. 7. 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. 8. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests,and other study procedures.
Exclusion criteria
Exclusion criteria: Subjects presenting with any of the following will not be included in the study: 1. Bladder cancer without any urothelium carcinoma component,such as adenocarcinoma,squamous cell carcinoma, small cell carcinoma; 2. Evidence of distant metastasis beyond the pelvis; 3. No definitely pathlogical 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 for the dissected lymph node number is less than ten nodes. 4. Prior neoadjuvant chemotherapy (systemic or intra-arterial) three months preoperatively, not including intra-vesical infusion chemotherapy; 5. Prior pelvic radiation therapy dosage >=30Gy six months preoperatively; 6. Serious liver and kidney dysfunction; 7. Accompanied with other serious diseases; 8. Severe/unstable angina, arrhythmia, symptomatic heart failure, hypertension that cannot be controlled by medications and 6 months for myocardial infarction; 9. Non-compliance of regular follow-up due to psychological, social, family and geographical and other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2, 3, 5 year local progression-free survival;2, 3, 5-year distant metastasis-free survival;5 year disease specipic survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| 5-year overall survival; | — |
Countries
China
Contacts
Public ContactFangjian Zhou, Zhuowei Liu
Outcome results
None listed