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Mitomycins

Mitomycin

Intravesical instillation of 40mg mitomycin C at 43 degrees for 60 minutes immediately after transurethral resection of bladder tumour

Hyperthermic intravesical chemotherapy

This is a prospective single-arm pilot study investigating the safety and feasibility of giving hyperthermic intravesical chemotherapy immediately following transurethral resection of bladder tumour.

The Combat Bladder Recirculation System (BRS) is a CE marked device which has been used in over 200 sites in Europe. It is an aluminum heat exchanger that allows hyperthermic intravesical chemotherapy (HIVEC) at 43±0.2 degrees for patients with bladder cancer. Previous studies showed that the Combat BRS could warm the entire bladder wall to the target temperature with excellent safety parameters. The flow rates and pressure levels are kept low during the HIVEC treatment. A previous study has demonstrated the safety and tolerability of HIVEC as a maintenance therapy for patients with non-muscle-invasive bladder cancer (NMIBC), and two randomized controlled trials are underway to demonstrate its efficacy in terms of disease recurrence and progression. On the other hand, the use of HIVEC immediately following transurethral resection of bladder tumour (TURBT) remains largely unexplored. It is the investigators' current practice to give intravesical mitomycin C (MMC) to all patients who have endoscopically NMIBC with complete resection, provided that there are no bladder perforations being noted. In this study, the investigators shall evaluate the safety and feasibility of hyperthermia in addition to the current practice of intravesical MMC alone immediately following TURBT.

Use of Immediate Hyperthermic Intravesical Chemotherapy Following TURBT

A Pilot Study on the Use of Immediate Hyperthermic Intravesical Chemotherapy Following Transurethral Resection of Bladder Tumour (I-HIVEC Study)

Complications which occur within 30 days after the experimental treatment

Rate of hyperthermic intravesical chemotherapy instillation given after the operation

Duration of urethral catheterisation after the experimental treatment

Rate of bladder irrigation given after the experimental treatment

Duration of bladder irrigation after the experimental treatment

Duration of hospital stay for the experimental treatment

Chinese University of Hong Kong

Assistant Professor

Recurrence

Non-Muscle Invasive Bladder Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gemcitabine

Antimetabolites

Patients undergo Transurethral Resection of Bladder Tumors (TURBT) and receive Intravesical Chemotherapy.

Patients undergo Transurethral Resection of Bladder Tumors (TURBT) and Hyperthermic Intravesical Chemotherapy (HIVEC)

Transurethral Resection of Bladder Tumors

TURBT

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.

HIVEC

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.

Intravesical Chemotherapy

Shuzhong Cui, MD

Jing Li, MD

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.

HIVEC in Patients With Non-Muscle-Invasive Bladder Cancer

A Multicenter Prospective Randomized Controlled Clinical Trial of Hyperthermic Intravesical Chemotherapy After Transurethral Resection of Bladder Tumors in Patients With Non-Muscle-Invasive Bladder Cancer

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%.

1-year recurrence rate = number of recurrence cases within 1 years / total number of enrolled cases \* 100%.

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 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.

IPSS is International Prostate Symptom Score (IPSS), 0\~35, the higher the score, the worse the symptom severity is.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Use of Immediate Hyperthermic Intravesical Chemotherapy Following TURBT	NCT03689478	Bladder Cancer Hyperthermia Chemotherapy Ef...	Hyperthermic in...	18 Years -	Chinese University of Hong Kong
HIVEC in Patients With Non-Muscle-Invasive Bladder Cancer	NCT06327932	Non-Muscle-Inva...	TURBT HIVEC Intravesical Ch... Gemcitabine	18 Years - 80 Years	Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Spots Global Cancer Trial Database for hyperthermic intravesical chemotherapy