Intravesical Hyaluronic Acid (HA) for Preventing Radiation Cystitis on Bladder Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorNational Cancer Center, Korea
About this trial
To evaluate the efficacy and safety of intravesical hyaluronic acid (HA) instillation therapy for the prevention of radiation-induced cystitis in patients undergoing radiotherapy for bladder cancer.
Eligibility criteria
Qualifiers
Pathologic confirmed Muscle-Invasive Urothelial Carcinoma I. Clinical stage: T2-T4a MIBC II. No or limited nodal involvement (N0 or partial N1, only isolated or regional) III. No distant metastasis (M0) IV. Transurethral resection of bladder tumor (TURBT): Maximal TURBT is available > Most tumors must be resected, and residual disease should be minimized.
Age ≥ 19
Karnofsky performance score (KPS) ≥ 70 or ECOG performance status 0~2
Patients who are candidates for bladder-preserving therapy, specifically those scheduled to undergo concurrent chemoradiotherapy (CCRT) instead of radical cystectomy.
Disqualifiers
Present of distant metastasis (M1)
Tumor invasion beyond the bladder wall into adjacent organs (T4b)
Non-urothelial carcinoma (including histologic variant) or predominant of non-urothelial components in mixed histology
Medically inoperable status or poor general condition (ECOG performance status > 2)
Trial design
Treatments tested in this trial
- Blad-Care (sodium hyaluronate 1.6%, 800 mg/50 mL, BioPlus Co., Ltd.)
- Normal Saline (NS)
Treatment groups
54 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov