A Phase 3 interventional study of TURBT and HIVEC in Non-Muscle-Invasive Bladder Cancer, sponsored by Affiliated Cancer Hospital & Institute of Guangzhou Medical University. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-03-25.
Sponsored by Affiliated Cancer Hospital & Institute of Guangzhou Medical University · Phase 3, Interventional, and Prevention
The purpose of this study is to determine the efficacy and safety of Hyperthermic Intravesical Chemotherapy (HIVEC) with Gemcitabine (GEM) after Transurethral Resection of Bladder Tumors (TURBT) in the treatment of medium or high-risk group Non-Muscle-Invasive Bladder Cancer (NMIBC).
In this study, patients with Non-Muscle-Invasive Bladder Cancer (NMIBC) and planed to undergo Transurethral Resection of Bladder Tumors (TURBT) are randomized into HIVEC group and control group. In HIVEC group, HIVEC is performed with Gemcitabine Gemcitabine (3g/150ml NS) at 45 °C for 60 minutes within 4 weeks, once a week (±5 days) for 6 to 8 times, once a month to 1 year. For the patients in the control group, Intravesical Chemotherapy is administered after TURBT. The primary endpoint is 2-year recurrence rate. Secondary end points include 1-year recurrence rate, recurrence-free survival (RFS) rate, disease free survival (DFS) rate, time to treatment failure (TTF), Success rate of therapeutic operation, Instrument performance evaluation, quality of international prostate symptom score, quality of Urinary Symptoms Distress Score. All efficacy analyses are conducted in the intention-to-treat population. Safety analysis include only patients who receive their randomly assigned treatment.
1,617 studies on the registry are indexed under Urinary Bladder Neoplasms; 422 are open to participants now.
This study's planned enrollment of 320 is above the median of 60 across 1,163 interventional studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →Affiliated Cancer Hospital & Institute of Guangzhou Medical University is the lead sponsor of 28 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
Patients undergo Transurethral Resection of Bladder Tumors (TURBT) and receive Intravesical Chemotherapy.
Procedure: TURBT · Procedure: Intravesical Chemotherapy · Drug: Gemcitabine
Patients undergo Transurethral Resection of Bladder Tumors (TURBT) and Hyperthermic Intravesical Chemotherapy (HIVEC)
Procedure: TURBT · Procedure: HIVEC · Drug: Gemcitabine
Transurethral Resection of Bladder Tumors
Hyperthermic Intravesical Chemotherapy with Gemcitabine (3g/150ml NS) at 45 °C for 60 minutes. Induction perfusion was required to start within 4 weeks, once a week (±5 days) for 6 to 8 times. After the last induction infusion, maintenance infusion was performed, once every month (±2 weeks) for 1 year from the first induction infusion.
Intravesical Chemotherapy with Gemcitabine (3g/150ml NS). Induction perfusion was required to start within 4 weeks, once a week (±5 days) for 6 to 8 times. After the last induction infusion, maintenance infusion was performed, once every month (±2 weeks) for 1 year from the first induction infusion.
Gemcitabine (3g/150ml NS).
Recurrence rate
The patients were observed for 2 years since they received HIVEC or intravesical chemotherapy，and cystoscopy was repeated every 3 months. If a new tumor-like organism is seen under the microscope, and pathology indicates urothelial carcinoma of the bladder after TURBT or cystoscopic biopsy, the tumor is considered to have recurred. 2-year recurrence rate = number of recurrence cases within 2 years / total number of enrolled cases \* 100%.
Time frame: 2-year
1-year recurrence rate
1-year recurrence rate = number of recurrence cases within 1 years / total number of enrolled cases \* 100%.
Time frame: 1-year
Recurrence-free survival (RFS) rate
Recurrence free survival is calculated from the date of randomization to the date of record recurrence or death from any cause, whichever occurred first.
Time frame: 2-year
Time to treatment failure
Time to treatment failure is calculated from the date of randomization to the date of treatment discontinuation/termination, including any reason for discontinuation/termination, such as disease progression, death, withdrawal due to adverse events, subject's refusal to continue the study, or use of a new treatment.
Time frame: 2-year
Success rate of therapeutic operation
Success rate of therapeutic operation
Time frame: 2-year
Quality of international prostate symptom score
IPSS is International Prostate Symptom Score (IPSS), 0\~35, the higher the score, the worse the symptom severity is.
Time frame: Evaluation was performed during the screening period and at 3, 12 and 24 months after initiation of treatment.
Quality of bother of score
BS is Bother of Score (BS), 0\~6, the higher the score, the worse the performance is.BS is the Bother of Score (BS), 0\~6, the higher the score, the worse the performance is.
Time frame: Evaluation was performed during the screening period and at 3, 12 and 24 months after initiation of treatment
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This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Affiliated Cancer Hospital & Institute of Guangzhou Medical University