Randomized Trial of Concomitant Hypofractionated IMRT Boost Versus Conventional Fractionated IMRT Boost for Localized High Risk Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- Acute Toxicity
研究概览
简要总结
Randomized trial comparing 2 external beam radiotherapy fractionation schemes in patients with localized high risk prostate cancer. Primary endpoint is acute toxicity.
详细描述
Patients enrolled onto this study will be randomized to one of the following treatment arms:
- Standard fractionation: Using 2 sequential IMRT plans, the pelvic lymph nodes and prostate will initially be treated to 46 Gy in 23 fractions, followed by a subsequent boost to the prostate to a total dose of 78 Gy.
- Hypofractionation: Using a one phase IMRT plan, the pelvic lymph nodes will be treated to a dose of 48 Gy in 25 fractions, while the prostate will be treated to a dose of 68 Gy in 25 fractions concomitantly (simulataneous integrated boost).
In addition, all patients receive 1.5- 3 years of androgen deprivation therapy.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Written informed consent obtained.
- •Histologically confirmed diagnosis of adenocarcinoma of the prostate.
- •T1-2 N0 M0, Gleason Score <= 7, PSA 20 - 100
- •T1-2 N0 M0, Gleason Score 8 - 10, PSA <= 100
- •T3 N0 M0, any Gleason Score, PSA <= 100
排除标准
- •Patients with unilateral or bilateral hip replacement.
- •Patients with active collagen vascular disease.
- •Patients with active inflammatory bowel disease.
- •Patients with previous radiotherapy to the pelvis.
- •Patients with ataxia telangiectasia.
- •Patients with nodal or distant metastases
研究组 & 干预措施
Standard Fractionation
Using 2 sequential IMRT plans, the pelvic lymph nodes and prostate will initially be treated to 46 Gy in 23 fractions, followed by a subsequent boost to the prostate to a total dose of 78 Gy.
干预措施: Conventionally Fractionated versus Hypofractionated Boost (Radiation)
Hypofractionation
Using a one phase IMRT plan, the pelvic lymph nodes will be treated to a dose of 48 Gy in 25 fractions, while the prostate will be treated to a dose of 68 Gy in 25 fractions concomitantly (simulataneous integrated boost).
干预措施: Conventionally Fractionated versus Hypofractionated Boost (Radiation)
结局指标
主要结局
Acute Toxicity
时间窗: within 3 months after starting radiotherapy
Proportion of patients experiencing grade \>=2 acute toxicity
次要结局
- Biochemical Control (Phoenix Definition)(at 5 years)
- Overall Survival(at 5 years)
- Late Toxicity(beyond 3 months of starting radiotherapy)
研究者
Dr. Patrick Cheung
Radiation Oncologist
Sunnybrook Health Sciences Centre