Observational Clinical Study of Patients With Muscle - Invasive Bladder Cancer Undergoing Bladder Preservation Therapy After Neoadjuvant Therapy

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07053722

Enrollment

Registered

2025-07-08

Start date

2025-06-30

Completion date

2027-06-30

Last updated

2025-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder (Urothelial, Transitional Cell) Cancer

Keywords

radiation oncology, bladder cancer, TMT

Brief summary

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

RADIATIONNA-TMT

After neoadjuvant therapy, patients choose trimodality therapy (TMT) for bladder preservation over radical cystectomy.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
DFS	5 years
OS	5 years
BI - EFS	5 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026