Observational Clinical Study on High - Risk NMIBC Patients Choosing Trimodality Bladder - Sparing… (NCT07053748) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Observational Clinical Study on High - Risk NMIBC Patients Choosing Trimodality Bladder - Sparing Therapy
30 participantsStarted 2025-06-30
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.