Use of controlled heated intravesical chemotherapy in urinary bladder cancer

Not yet recruiting

• Conditions: Bladder disorder, unspecified,

• Registration Number: CTRI/2022/02/040185
• Lead Sponsor: Rajiv Gandhi Cancer Institute and Research Centre

Brief Summary

Carcinoma urinary bladder is most common urothelial cancer of urinary tract. Carcinoma urinary bladder is notorious for its high recurrence rates. Single dose of intravesical mitomycin in postoperative period has been recommended to reduce recurrence rate in patients of low and intermediate risk disease. The biologic rational for delivery of single postoperative dose of intravesical chemotherapy is based on the antitumor effects against tumor cells suspended in the bladder and residual tumor cells at the base of the resection bed following TURBT. Contemporary meta-analysis of randomized trials including 2278 patients reported a risk of recurrence reduction by 35% [hazard ratio (HR) 0.65; 95% confidence interval (CI) 0.58–0.77, *p* < 0.001] and absolute risk reduction of 14% at 5 years. So, guideline recommendations support the use of a single postoperative intravesical dose of chemotherapy [e.g.: mitomycin C (MMC) or epirubicin] immediately after TURBT for patients with low-risk NMIBC.

Hyperthermic intravesical chemotherapy is a new technique, where mitomycin is given into urinary bladder at temperature of 41 - 43°C. Investigators reported significant improvement in disease control for high and intermediate risk disease in comparison to mitomycin.

Hyperthermic intravesical mitomycin has not been studied in postoperative setting, whereas mitomycin has been already in use in postoperative setting with proven efficacy. In view of better efficacy of HIVEC in comparison to mitomycin, we propose better oncological results with HIVEC in immediate postoperative setting.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-15
• Last Update Posted: 2022-07-02

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Post-operative hyperthermic intravesical mitomycin will be given in all patients of non muscle invasive bladder cancer.

Exclusion Criteria

• 1. Patient having:.
• gross hematuria.
• bladder perforation.
• muscle invasive disease 2. Patient not willing to sign consent for the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events	Adverse events which occur within 30 days after the study intervention.

Secondary Outcome Measures

Name	Time	Method
to assess Recurrence free survival, Progression free survival	Every 3 monthly.

Trial Locations

Locations (1)

Rajiv Gandhi Cancer Institute and Research Centre; 🇮🇳 West, DELHI, India

Rajiv Gandhi Cancer Institute and Research Centre

🇮🇳West, DELHI, India

Dr Amitabh Singh

Principal investigator

01147022065

amitabhsingh27@gmail.com