A Phase I/II Study of Escalated-Dose Short-Course Hypofractionated Radiotherapy (55 Gy/16 Fractions/4 Weeks) for Localized Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- rectal toxicity
研究概览
简要总结
Many patients with localized prostate cancer choose radiotherapy for treatment. Recent improvements in technology have lead to better outcomes with less side effects and better disease control rates by allowing high doses of radiation to be delivered to the cancer with lower doses to surrounding healthy tissues. Currently patients are required to attend daily treatments over seven to eight weeks which can be costly and disruptive for patients, especially those not living close to a cancer centre.
There is recent research that suggests that the same or better outcomes might be achieved in prostate cancer by delivering a smaller number of treatments, but with a higher dose of radiation given on each visit, over a shorter time than the usual seven to eight weeks.
In this study the investigators propose to treat patients with prostate cancer using 16 treatments over four weeks, thus reducing the number of visits to the cancer centre for treatment by 50%.
详细描述
Purpose:
- To determine the acute and late effects of high-dose short-course hypofractionated radiotherapy of 55 Gy/16 fraction/4 weeks in the treatment of localized prostate cancer.
- To provide clinical data for confirmation of current linear-quadratic radiobiological model of fractionation sensitivity in the treatment of prostate cancer by external beam radiotherapy.
Radiotherapy for Prostate Cancer:
In 2003, 18,800 Canadians were expected to be diagnosed with prostate cancer, 2000 of whom were in Alberta. Prostate cancer represents a significant workload in most Canadian cancer centres. At the Cross Cancer Institute (CCI), approximately 400 patients underwent a radical course of external beam radiotherapy in 2002. Typically, each course of radiation consisted of 35 fractions given over 7 weeks. Assuming an ideal efficiency of patient turnover on a given linear accelerator, 3000 machine hours would be required to treat 400 patients.
At present, clinical trials are on-going to confirm that an increase in radiation dose given over 39-44 fractions per patient will be more efficacious than the current standard of 35-39 fractions. Such an increase in radiation dose will require an increase in treatment capacity by 10% without increasing the number of patients treated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Low/intermediate risk localized prostate cancer
排除标准
- •High risk, metastatic
- •Patient refusal
结局指标
主要结局
rectal toxicity
时间窗: Study completion
次要结局
- Prostate-specific antigen (PSA) control(Study completion)