Observational Clinical Study of Patients With Muscle - Invasive Bladder Cancer Undergoing Bladder Preservation Therapy After Neoadjuvant 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: NA-TMT.
- Who it may be relevant to
- Registry conditions: Bladder (Urothelial, Transitional Cell) Cancer. 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 →
Unsure about the terms? Read our patient guide →
Overview
The goal of this observational study is to evaluate the safety and efficacy of neoadjuvant therapy followed by bladder - preserving TMT in patients with MIBC. The main question it aims to answer is: Does this treatment model improve long - term outcomes, including survival, local control, distant metastasis, and bladder preservation rates? Participants who received neoadjuvant therapy and underwent TMT for bladder preservation will be observed.
Interventions
- Radiation NA-TMT
After neoadjuvant therapy, patients choose trimodality therapy (TMT) for bladder preservation over radical cystectomy.
Primary outcome measures
- DFS [Time frame: 5 years]
- OS [Time frame: 5 years]
- BI - EFS [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
Histopathologically confirmed bladder cancer (T2-T4aN0-2M0, 8th edition AJCC staging).
Underwent bladder - sparing TMT following neoadjuvant therapy (ADC, immunotherapy, or chemotherapy).
Aged ≥18 years. Signed an informed consent form. Good general condition with ECOG performance status of 0-2. Adequate organ function for chemoradiotherapy: (1) Hematology: Absolute neutrophil count ≥1.5×10⁹/L, platelets ≥100×10⁹/L, hemoglobin ≥90 g/L. (2) Liver function: Total bilirubin ≤1.5×ULN, ALT and AST ≤2.5×ULN (≤5×ULN if hepatic metastasis is present). (3) 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: NCT07053722 · NA-TMT-001