bladder cancer
Conditions
Interventions
Research group (bladder-preserving combined-modality therapy based on neoadjuvant therapy):none
Control group (trimodal therapy):none
Sponsors
Xiangya Hospital Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients with urothelial carcinoma of bladder confirmed by pathology (histological variation may exist); 2. In accordance with the CUA2019 guidelines for radical cystectomy; 3. Karnofsky score (Annex 1) >= 70; 4. Age >= 18 years old; 5. From January 2016 to December 2020, he was admitted to Xiangya Hospital of Central South University; 6. Received comprehensive treatment of bladder preservation or radical cystectomy; 7. Laboratory indicators: neutrophil count (ANC) >= 1000/mm3, platelet count >= 100000/mm3, hemoglobin >= 9.0 g/dL, bilirubin = 60mL / min (GC or GC+ICI) or CCR >= 30mL / min (ICI) (using Cockcroft-Gault formula: creatinine clearance rate for men = (140-age) * body weight (kg) / 72 * serum creatinine (mg/dl) or creatinine clearance rate = (140-age) * body weight (kq) / [0.818 * serum creatinine (umol/L)], while women multiplied by 0.885); 8. Women used contraceptives (IUD, contraceptive or condoms) during the study and 6 months after the end of the study; negative serum or urinary pregnancy tests within 7 days before the study, which must be non-lactation patients; men who used contraception during the study period and 6 months after the end of the study period.
Exclusion criteria
Exclusion criteria: 1. Previously received radiotherapy, immunotherapy and other tumor adjuvant therapy; 2. Severe heart disease (i.e. class III and above cardiac function); 3. Severe medical or mental illness, including severe active infections; 4. Underwent other surgeries 4 weeks ago; 5. The following symptoms occur within 6 months: myocardial infarction, severe / unstable angina pectoris, coronary artery / peripheral artery bypass, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack; 6. Persistent arrhythmia >= 2 (NCI CTCAE Version 4.0grade); 7. Diseases or infections related to human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS); 8. Participated in other clinical trials at the same time; 9. Alcohol or narcotic substance abuse, history of drug use, or history of mental illness (such as schizophrenia, obsessive-compulsive disorder, depression), confrontational personality, bad motivation, paranoia or other emotional or intellectual problems.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival (DFS);complete response (CR);Drug side effects;Adverse reactions of radiotherapy;Complication; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS); | — |
Countries
China
Contacts
Public ContactXiongbing Zu
Xiangya Hospital Central South University
Outcome results
None listed