A Randomised, Two Centre Trial on Daily Cone-beam vs Standard Weekly Orthogonal Image Guided Radiotherapy (IGRT) for 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
- 260
- 试验地点
- 2
- 主要终点
- Acute rectal side effects
研究概览
简要总结
The clinical importance of cone beam computer tomography based image guided radiotherapy (CT- IGRT) has not been established. The primary aim of the present trial is to investigate whether CT- IGRT and consequently reduced safety margins reduces the rectal side effects from curative, high dose radiotherapy in prostate cancer. Any impact of the reduced planning target volume in the CT- IGRT arm on biochemical freedom from disease will be evaluated as secondary outcome.
An open randomised phase III trial. The included men will be randomised to receive curative radiotherapy to 78 Gy in 39 fractions with weekly orthogonal position verification and standard safety margins (10-15 mm) or 78 Gy in 39 fractions with daily CT position verification and reduced safety margins (7mm).
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 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Biopsy confirmed adenocarcinoma of prostate
- •No evidence of nodal or distant metastases (N0M0)
- •Intermediate or high risk based on T stage, PSA level and Gleason score
- •Informed consent
排除标准
- •Previous treatment for cancer last 5 years, except basal cell carcinoma of skin
- •Any previous radiotherapy, except KV or electron treatment of skin tumors outside the pelvis
- •Metallic hip joint replacement
- •Pre-existing intestinal or genitourinary disease with increased risk of side effects
- •Any pre-existing condition making the patient unsuitable for radiotherapy
- •Any pre-existing condition making the patient unsuitable for hormonal therapy
- •Any pre-existing condition making the patient unsuitable for MRI.
- •ALAT, GT, ALP, creatinin > 1.5 x upper normal limit
结局指标
主要结局
Acute rectal side effects
时间窗: 10 weeks
FWUO94
次要结局
- Freedom from biochemical failure(3 years)
- Late genitourinary and rectal side effects(up to 10 years)
- quality of life(up to 10 years)
- Overall survival(up to 10 years)
- Cancer specific survival(up to 10 years)
- Acute genitourinary side effects(10 weeks)