Intravesical Hyaluronic Acid (HA) for Preventing Radiation Cystitis on Bladder Cancer : A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Primary endpoint
研究概览
简要总结
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.
详细描述
Study Design: Single-blind, Randomized, Controlled trial.
- Primary endpoint
- To assess patient-reported outcomes (PROs) related to symptoms of radiation-induced cystitis in patients with bladder cancer undergoing radiotherapy.
-
Secondary endpoint
-
To evaluate tumor control rates in patients with bladder cancer undergoing radiotherapy.
-
To assess the incidence and severity of radiation-induced cystitis using RTOG/EORTC criteria, CTCAE grading, and cystoscopic findings.
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To compare healthcare costs between the treatment group receiving intravesical hyaluronic acid instillation and the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
- •V. Preserved bladder function is required: patients must have normal bladder capacity and maintain adequate voiding function.
- •VI. Unifocal or localized tumor (except multifocal) VII. No extensive carcinoma in situ (CIS)
- •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.
- •Patients scheduled to receive radiotherapy in combination with one or more of the following chemotherapeutic agents prior to study enrollment: Cisplatin-based chemotherapy (e.g. weekly cisplatin), Gemcitabine or 5-FU/mitomycin, in accordance with standard clinical practice.
- •Written informed consent obtained from the patients prior to study participation
排除标准
- •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)
- •History of active cystitis or recurrent urinary tract infections within the past 6 months
- •Known hypersensitivity to hyaluronic acid or related compounds
- •Any condition in which, in the investigator's judgment, administration of the study drug or procedure is deemed inappropriate
- •Pregnant or breastfeeding women, or women of childbearing potential who are unable or unwilling to use adequate contraception during the study period
结局指标
主要结局
Primary endpoint
时间窗: 12 months
To assess patient-reported outcomes (PROs) related to symptoms of radiation-induced cystitis using the EORTC QLQ-BLM30 questionnaire (Korean version) in patients with bladder cancer undergoing radiotherapy.
次要结局
- Tumor Control(12 months)
- Radiation-induced cystitis(12 months)
- healthcare costs(12 months)
研究者
Sung Uk Lee
M.D., Ph.D.
National Cancer Center, Korea