Bladder cancer
Conditions
Interventions
B:Laparoscopic radical cystectomy
A:Open radical cystectomy
C:robotic-assisted radical cystectomy
Sponsors
Department of Urology, Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, 200127 Shanghai, China
Eligibility
Sex/Gender
Male
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Clinical diagnosis of resectable muscle-invasive urothelial carcinoma, staging cT2 ~ 4aN0 ~ 2M0; 2. TURBT surgery in our hospital, the pathological diagnosis of urothelial carcinoma (urinary tract epithelial cells and mixed urinary tract epithelial / non-urothelial cell histology); 3. 3 months of clinical and imaging studies without metastasis found (bone scan, MRI or CT scan + enhanced); 4. Aged 18 to 80 years old; 5. Eastern Cooperative Oncology Group (ECOG) PS 0 or 1; 6. EORTC QLQC-30 score =2; 7. Life expectancy = 2 years (investigator judgment); 8. Meet the following blood biochemical indicators: neutrophils = 1500/mm^3, platelet =100000 / mm^3, hemoglobin = 9 g/dL, bilirubin =upper limit (upper limit of normal, ULM), ALT and AST = 1.5 ULM, creatinine 60ml/min); 9. Patients signed the informed consent form before entering the group.
Exclusion criteria
Exclusion criteria: 1. Participate in the study of the planning and / or carried out (in this study participants and / or staff at Renji Hospital urologist are applicable); 2. Also included in another clinical study unless it is an observational (non-intervention) clinical study or a follow-up phase of an intervention study; 3. Malignant diseases occurring within five years, excluding the following, should be discussed with the investigator: 1) There is a history of prostate cancer with a staging = T2cN0M0 (tumor size/lymph node / metastatic staging), no biochemical recurrence or progression, and the investigators believe that no intervention is required; 2) patients who experience adequate anti-malignant tumor therapy and have low risk of recurrence (eg, surgically cured cervix in situ carcinoma, non-melanoma skin tumor, or breast ductal carcinoma); 4. Uncontrolled concurrent illnesses, including but not limited to: persistent or active infections, symptomatic congestive heart failure, uncontrolled hypertension, uncontrolled diabetes, unstable angina, arrhythmias, and Interstitial lung disease, severe chronic gastrointestinal disorders associated with diarrhea, or psychiatric / social problems that may limit compliance with the study requirements, resulting in a significant increase in the risk of adverse events or affecting the subject's ability to provide written informed consent; 5. Any intravenous chemotherapy, immunotherapy, radiotherapy, biotherapy or hormone therapy for any treatment of cancer within 6 months; a) the use of hormones at the same time to treat non-tumor-related diseases (such as hormone replacement therapy) is acceptable; b) Neoadjuvant chemotherapy based on cisplatin after diagnosis of myometrial invasive bladder cancer is acceptable; c) Intravesical chemotherapy and immunotherapy (BCG) are acceptable; 6. History of allogeneic organ transplantation requiring immunosuppressive agents; 7. History of active primary immunodeficiency disease; 8. Active infection, including tuberculosis (clinical assessment, including clinical history, physical examination and radiological discovery and tuberculosis check in accordance with local operations), hepatitis B, hepatitis C, or human immunodeficiency virus (HIV, HIV 1/2 antibody positive) The Active hepatitis B virus (HBV) infection was defined as positive for HBV surface antigen (HBsAg). Previously patients with HBV infection or have been relieved (defined as the presence of hepatitis B core IgG antibody and no HBsAg, deoxyribonucleic acid [DNA] negative) were eligible. Patients with hepatitis C virus (HCV) positive antibody are eligible only if HCV ribonucleic acid (RNA) polymerase chain reaction is negative; 9. Female patients during pregnancy or lactation; 10. Patients with body weight <30 kg.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| post-operative complications in 30 days; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Progress-free survival;operative bleeding;operative duration time; | — |
Countries
China
Contacts
Public ContactCHEN Haige
Department of Urology, Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed