Assessment of Quality of Life and Outcomes in Patients Treated With Stereotactic Body Radiotherapy (SBRT) for Inoperable Renal Cell Carcinoma (RCC): A Multicenter Phase II Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Local Control at 2 years
研究概览
简要总结
This is a multicenter, single arm phase II study of stereotactic body radiation therapy (SBRT) for patients with medically inoperable primary renal cell carcinoma (RCC).
详细描述
Primary renal cell carcinoma (RCC) is a common malignancy in Canada. The current standard of care for fit patients with localized RCC is surgical resection of the kidney (nephrectomy). RCC, however, affects predominately an older population with a median age at diagnosis of 65 years. Surgery is often not an option for these patients due to existing co-morbidities, and in an increasing environment of shared decision making in healthcare, some patients decline surgical resection and seek less invasive alternatives.
Stereotactic body radiotherapy (SBRT) is a treatment approach that offers precise delivery of highly conformal radiotherapy to the tumour with minimal exposure to the surrounding normal tissues. SBRT is non-invasive and not limited by the size or location of kidney tumors like other ablative strategies. The worldwide experience of treating RCC with SBRT is growing and the results to date are promising. There is broader enthusiasm from both the radiation oncology and urology community to increase utilization of SBRT for RCC in non-surgical patients within the context of a well-designed prospective trial in Canada.
The investigators will prospectively assess the efficacy, toxicity and impact on quality of life (QoL) of SBRT in the treatment of inoperable RCC
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients ≥18 years old
- •Newly diagnosed RCC by biopsy (preferred) or radiologic evidence of growth on surveillance over two consecutive assessments (6-12 months)
- •Primary lesion >3 cm, or recurrent lesion following local ablative therapy
- •Medically inoperable or patient who refuses surgery following assessment by experienced urologist, and discussed in a multidisciplinary setting
- •Written informed consent
- •Participants must be able to understand the English-language or with the aid of a translator
排除标准
- •Primary Lesion >20cm
- •Evidence of distant metastatic disease
- •Previous abdominal RT in vicinity of kidney preventing definitive SBRT
- •History of major radiosensitivity syndrome
- •Second invasive malignancy within the past 3 years (excluding non-melanomatous skin cancer)
- •Currently pregnant or lactating
研究组 & 干预措施
SBRT for Medically Inoperable RCC
35-45 Gy in five fractions (7-9 Gy/day)
干预措施: Stereotactic body radiotherapy (Radiation)
结局指标
主要结局
Local Control at 2 years
时间窗: 2 years
Local control at 2 years defined as the absence of progression of disease of the treated primary kidney cancer using Responsive Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
次要结局
- Late treatment-related toxicities(week 4-6 post-SBRT, and months: 3,6,9,12,18,24 and 36)
- Health utilities(Baseline, week 4-6 post-SBRT, and months: 3,6,9,12,18,24 and 36)
- Quality of life of Participants(Baseline, week 4-6 post-SBRT, and months: 3,6,9,12,18,24 and 36)
- Progression-free and Overall survival(week 4-6 post-SBRT, and months: 3,6,9,12,18,24 and 36)
- Severity of late treatment-related toxicity(6-60 months)
- Incidence of late treatment-related toxicity(6-60 months post-SBRT)
- Quality of life score (e.g., EPIC-26 or other tool)(Months 3, 6, 9, 12, 18, 24, 36, 48, and 60 post-SBRT)
- Late Toxicity(Week 4-6 post-SBRT)
研究者
William Chu, MD, MSc, FRCPC
Assistant Professor, Department of Radiation Oncology, University of Toronto
Sunnybrook Health Sciences Centre