Local Radiotherapy for Urinary Bladder Cancer in Patients Not Eligible for Curative Treatment; a Prospective Randomized Phase III Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 248
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
The goal of this clinical trial is to improve the quality of life and prolong survival in bladder cancer patients unfit for curative treatment. The trial will compare the survival and symptoms of patients randomized to either local radiotherapy in addition to standard of care or standard of care alone.
Using modern radiotherapy techniques, including hypofractionation and image-guided treatment adaptation, the aim is to deliver a well-tolerated, time-efficient, and effective treatment strategy for these patients.
The trial collaborates with two ongoing exploratory biomarker studies collecting and analyzing potential biomarkers in urothelial bladder cancer. The hope is to provide biomarkers for prognosis and treatment response which is essential to ensure bladder cancer patients individualized treatment in the future, like those with breast and prostate cancer.
详细描述
Around 700 individuals in Sweden are diagnosed each year with muscle-invasive bladder cancer (MIBC), and a similar number die annually from the disease (SVF RCC 2023). With a median age at diagnosis approaching 76 years (Swedish National Quality Registry for Urothelial Carcinoma), the incidence is expected to rise as the population ages.
Due to advanced age and comorbidity, many patients are not eligible for the demanding multimodal treatments used with curative intent. Recently introduced systemic therapies for palliation, such as antibody-drug conjugates and immunotherapy, also require a WHO performance status <2 and regular hospital-based administration. Consequently, up to 30% of patients receive no tumor-directed therapy at diagnosis (Swedish National Quality Registry for Urothelial Carcinoma).
Without treatment, MIBC often progresses rapidly, with a median overall survival of approximately 12 months in this cohort. Symptom burden is substantial, commonly involving pain, bleeding, and urinary tract obstruction, which frequently require repeated hospital admissions late in the disease trajectory.
Radiation therapy (RT) is an established curative modality in bladder cancer and is well documented for symptom palliation. In other malignancies, such as prostate cancer, limited radiation doses have been shown to prolong survival and reduce the development of distressing symptoms. Although some studies indicate similar benefits in bladder cancer, a clear survival effect has not been demonstrated, representing an important knowledge gap in the management of a common cancer type.
The LORUP project builds on existing translational research infrastructures to address this gap. Its aim is to develop a treatment strategy for MIBC patients unfit for curative therapy, focused on improving quality of life by reducing symptom burden and potentially prolonging survival, while maintaining a low treatment burden and minimal side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Oral and written consent
- •Histologically confirmed MIBC with urothelial component
- •Male or female participants ≥ 18 years old
- •Deemed not to benefit from curative treatment at a multidisciplinary tumour conference (MDT) or having declined curative treatment of their own accord.
排除标准
- •Clinical Fragility Scale score ≥8
- •Previous pelvic RT with significant overlap
- •Visceral or bone metastases on CT scan
- •Multiple (>3) lymph node metastases with a measurement of >2 cm on CT scan
- •Planed for systemic treatment at the time of inclusion.
- •Local RT to the bladder indicated for the palliation of symptoms at the time of inclusion.
研究组 & 干预措施
Arm B - SoC
Standard of care. All applicable palliative treatments, such as local RT, TURB, systemic anti-tumour treatments or other interventions/treatments applicable according to treating physician are allowed.
干预措施: Standard of Care (Investigator Choice) (Other)
Arm A - RT and SoC
Local hypo fractionated adaptive radiotherapy to the bladder, 7 Gy in 3 fractions delivered every other day (eod) prescribed in addition to standard of care.
干预措施: Local hypo fractionated adaptive radiotherapy and Standard of Care (Radiation)
结局指标
主要结局
Overall Survival
时间窗: From date of randomization until the date of death from any cause assessed up to a minimum of 36 months
次要结局
- Disease specific Survival(From date of randomization until the date of death by MIBC assessed up to a minimum of 36 months)
- Progression-free survival(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to a minimum of 36 months)
- Radiological progression-free survival(Time from randomization to the date of the first documented radiological progression or death, whichever comes first, assessed up to a minimum of 36 months)
- Start of systemic anti-tumour treatment(Time from randomization to start of systemic anti-tumour treatment assessed up to a minimum of 36 months)
- Health related quality of life, HRQoL(Collected every fourth month throughout follow-up from randomization to 36 months of follow-up or until death of any cause, which ever comes first)
- Patient reported outcome, PRO(Collected at every follow up (month 1, 2 and thereafter every 4th month from randomization) until last follow-up visit at 36 months or until death of any cause, which ever comes first)
- Early adverse events /late adverse event(Collected at every follow up (month 1, 2 and thereafter every 4th month from randomization) until last follow-up visit at 36 months or until death of any cause, which ever comes first)
- Adverse event of special interest, AESI:(Collected throughout follow-up for a minimum of 36 months or until death of any cause, which ever comes first)