Observational Clinical Study on High - Risk NMIBC Patients Choosing Trimodality Bladder - Sparing Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Trimodality Bladder-preserving Therapy.
- Who it may be relevant to
- Registry conditions: High - Risk NMIBC. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Radiation Trimodality 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.
Primary outcome measures
- DFS [Time frame: 5 years]
- OS [Time frame: 5 Years]
- BI-DFS [Time frame: 5 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07053748 · 2025-1081