High - Risk NMIBC
Conditions
Keywords
Non-Muscle Invasive Bladder Cancer
Brief summary
The goal of this observational study is to assess the safety and efficacy of trimodality bladder - sparing therapy in high - risk NMIBC patients. The main questions it aims to answer are: Is trimodality therapy safe and effective in the short term for high - risk NMIBC patients? What is its long - term effectiveness in terms of EFS, OS, and BI - EFS? How does it affect patients' QOL? Participants will be high - risk NMIBC patients receiving trimodality therapy at Peking University First Hospital. They will be observed to evaluate the therapy's effectiveness and impact on QOL using relevant assessment criteria and QOL scores.
Interventions
RADIATIONTrimodality Bladder-preserving Therapy
High-risk NMIBC patients who have a strong desire to preserve their bladder actively choose to receive Trimodality Bladder-preserving Therapy instead of radical resection.
Sponsors
Peking University First Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Histologically confirmed NMIBC (Ta Tis T1). ≥2 recurrences after transurethral resection, or lack of response/intolerance to intravesical therapy (e.g., BCG). Refusal of radical cystectomy and choice of TMT for bladder preservation. Aged ≥18 years. Signed informed consent. ECOG performance status of 0-2. Adequate organ function for chemoradiotherapy: Hematology: Absolute neutrophil count ≥1.5×10⁹/L, platelets ≥100×10⁹/L, hemoglobin ≥90 g/L. Liver function: Total bilirubin ≤1.5×ULN, ALT and AST ≤2.5×ULN (≤5×ULN if hepatic metastasis is present). Renal function: Creatinine clearance ≥30 mL/min (via Cockcroft-Gault formula).
Exclusion criteria
Distant metastasis (M1). Other malignancies (except cured basal cell carcinoma or cervical carcinoma in situ). Severe cardiovascular disease (uncontrolled heart failure, unstable angina, myocardial infarction, etc.). Severe hepatic/renal dysfunction intolerance to chemoradiotherapy. Mental illness/cognitive impairment unable to comply with the study. Allergy to chemoradiotherapy drugs. Pregnant or breastfeeding women. Previous pelvic radiotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DFS | 5 years |
| OS | 5 Years |
| BI-DFS | 5 years |
Outcome results
None listed