bladder cancer
Conditions
Interventions
GC regimen neoadjuvant chemotherapy+radical cystectomy group:Chemotherapy began 28 days after randomization, with gemcitabine at 1000mg/m2, intravenous infusion on days 1 and 8, cisplatin at 70mg/m2,
dd MVAC regimen neoadjuvant chemotherapy+radical cystectomy group:Chemotherapy started 28 days after randomization, methotrexate 30mg/m2, intravenous drip on the first day, vinblastine 3mg/m2, doxorub
simple radical cystectomy group:Radical cystectomy combined with bilateral pelvic lymph node dissection was performed 28 days after randomization
Sponsors
900TH Hospital of Joint Logistics Support Force
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Primary bladder cancer with TNM stage of T2-4aN0M0; Within 8 weeks after transurethral resection of bladder tumors (TURBT); Pathology confirmed that the bladder urothelium carcinoma (urothelium carcinoma>50%); No concomitant urothelium cancer, except for non-muscle invasive bladder cancer, there was no history of other malignancies; No history of radiation and chemotherapy; Age 18-80 years old; The Eastern Oncology Collaborative Group (ECOG) in the United States scored 0-1 points; Organ function is normal [white blood cell count = 4000/mm3 or neutrophil count = 2000/mm3, platelet = 100000/mm3, creatinine clearance = 50ml/min, total bilirubin = 1.5mg/dl, glutamic oxaloacetic transaminase = 2.5 times of the upper limit of normal value, glutamic pyruvic transaminase = 2.5 times of the upper limit of normal value]; I have medical insurance and signed an informed consent form. The TNM staging requirements include ? pathological staging of TURBT specimens = T2; ? CT or magnetic resonance imaging did not detect lymph nodes or distant metastasis (pelvic lymph nodes = 10mm).
Exclusion criteria
Exclusion criteria: The pathological types are simple adenocarcinoma, simple squamous cell carcinoma, mixed carcinoma, or simple small cell neuroendocrine carcinoma; Ventricular ejection fraction<50%; History of other malignant tumors; Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event rate;progression-free survival;Chemotherapy response rate;Overall survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| response rate; | — |
Countries
China
Contacts
Public ContactMingfang Weng
900TH Hospital of Joint Logistics Support Force
Outcome results
None listed