This study will evaluate whether adjuvant intravesical chemotherapy can be safely omitted under active surveillance after complete transurethral resection in selected patients with EAU intermediate-risk non-muscle-invasive bladder cancer. Patients with intermediate-risk non-muscle-invasive bladder cancer are commonly treated with transurethral resection followed by adjuvant intravesical chemotherapy to reduce the risk of recurrence. However, not all patients may derive the same benefit from additional intravesical treatment. Some tumors may have a low-shedding phenotype, meaning that they show no detectable tumor-associated signals in urine despite the presence of visible bladder tumors. In this study, preoperative urine-based liquid biopsy will be used to identify patients with a low-shedding profile. This profile is defined by negative results across urine cytology, NMP22, urinary DNA methylation, and urinary tumor DNA testing before transurethral resection. Eligible patients with EAU intermediate-risk non-muscle-invasive bladder cancer, a negative preoperative urine-based liquid biopsy profile, and complete tumor resection will be randomly assigned to active surveillance or standard adjuvant intravesical chemotherapy. The study will compare recurrence-free survival between the two groups and assess whether active surveillance can avoid immediate intravesical chemotherapy without compromising oncologic safety. Secondary outcomes will include high-grade recurrence, disease progression, need for subsequent bladder cancer treatment, safety, patient-reported outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
670
Participants assigned to active surveillance will not receive adjuvant intravesical chemotherapy after complete transurethral resection of bladder tumor. They will undergo scheduled follow-up assessments, including cystoscopy, urine cytology, urine-based liquid biopsy testing, imaging when clinically indicated, and other evaluations according to the study protocol. Further diagnostic evaluation or treatment will be initiated if recurrence or progression is suspected or confirmed.
Participants assigned to this intervention will receive one year of adjuvant intravesical chemotherapy after complete transurethral resection of bladder tumor. Gemcitabine is the preferred protocol-specified agent. Mitomycin C or epirubicin may be used as protocol-allowed alternatives when gemcitabine is unavailable, contraindicated, or not routinely used at the participating center. Treatment will include an induction course followed by maintenance intravesical instillations for up to 12 months.
Daqing Oil General Hopital
Daqing, China
Nanchang Second People's Hospital
Nanchang, China
The Second Hospital of Tianjin Medical University
Tianjin, China
General Hospital of Tianjin Medical University
Tianjin, China
Tianjin Hospital
Tianjin, China
Recurrence-free survival
Recurrence-free survival is defined as the time from randomization to the first histologically confirmed intravesical recurrence or death from any cause, whichever occurs first.
Time frame: Up to 24 months after randomization
High-grade recurrence-free survival
High-grade recurrence-free survival is defined as the time from randomization to the first histologically confirmed high-grade intravesical recurrence or death from any cause, whichever occurs first.
Time frame: Frame: Up to 24 months after randomization
Progression-free survival
Progression-free survival is defined as the time from randomization to the first occurrence of T1 high-grade disease, carcinoma in situ, muscle-invasive bladder cancer, upper tract urothelial carcinoma, nodal or distant metastasis, radical cystectomy, or death from any cause.
Time frame: Up to 24 months after randomization
Overall Survival
Defined as the time from randomization to the date of death from any cause
Time frame: Up to 24 months after randomization
European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire Core-30 items (EORTC-QLQ-C30) Scores
EORTC QLQ-C30 is a core 30-item questionnaire for evaluating the health-related quality of life (HRQoL) of participants participating in cancer clinical studies. It incorporates 5 functional scales (physical, role, cognitive, emotional, and social functioning), 3 symptom scales (fatigue, pain, and nausea or vomiting), and a global health status or HRQoL scale. Ratings for each item range from 1 (not at all) to 4 (very much). Higher scores indicated greater severity.
Time frame: Baseline, Weeks 6, 12, 24, 36, and 48
European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire for Non muscle Invasive Bladder Cancer (EORTC-QLQ-NMIBC24) Scores
EORTC QLQ-NMIBC24 is a 24-item questionnaire for evaluating the HRQoL of participants with non-muscle-invasive bladder cancer. The questionnaire is designed to supplement the QLQ C30 and incorporates 6 multi-item scales and 5 single items. Ratings for each item range from 1 (not at all) to 4 (very much). Higher scores indicated greater severity.
Time frame: Baseline, Weeks 6, 12, 24, 36, and 48
EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Scores
The EQ-5D-5L is a standardized questionnaire used to assess participants' general health status and health-related quality of life. It includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response levels, ranging from 1 (no problems) to 5 (extreme problems or unable to perform). Responses can be converted into a health utility index score using an appropriate value set, with higher index scores indicating better health status. The EQ-5D-5L also includes a visual analogue scale (EQ VAS), ranging from 0 to 100, where higher scores indicate better self-rated health.
Time frame: Baseline, Weeks 6, 12, 24, 36, and 48
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