Prospective Study of siMultaneous Adaptive RadioTherapy for Local Boost for Prostate and Bladder Cancers (SMART-B01)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Acute GU and GI toxicities as per NCI-CTC 5.0 criteria 3-months post RT
研究概览
简要总结
The goal of this clinical trial is to learn if adaptive radiation boost works to treat genitourinary cancers, esp. in the context of prostate cancer patients with post-prostatectomy local relapse and bladder cancer patients with bladder-conserving treatment. It will also learn about the safety and efficacy of adaptive boost. The main questions it aims to answer are:
Does adaptive boost lower the toxicities? Does adaptive boost maintain or improve the clinical efficacy?
Participants will:
Undergo adaptive boost on 1.5-Tesla MR-Linac Visit the clinic once every 2 weeks during RT, and every 3 months post-ART Keep a regular QOL questinnaire completion
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with newly diagnosed or metastatic/recurrent pathologically confirmed urological tumors, clinically assessed as suitable for adaptive radiotherapy;
- •Age ≥ 18 years;
- •ECOG performance status score 0-2;
- •No prior radiotherapy history within the current radiation field;
- •No contraindications for MRI scanning;
- •No contraindications for radiotherapy.
排除标准
- •Patients with contraindications to radiotherapy;
- •Patients unable to tolerate MRI or with contraindications to MRI scanning.
结局指标
主要结局
Acute GU and GI toxicities as per NCI-CTC 5.0 criteria 3-months post RT
时间窗: 3-months post-RT
次要结局
- Quality-of-Life, general(Baseline, 1-month post-RT, every 3 months till 2-years post-RT)
- Local control(2-year)
- disease-free survival(2-year)
- Late toxicities(2-year)
- Quality-of-Life, sexual scales(Baseline, 1-month post-RT, every 3 months till 2-years post-RT)
- Quality-of-Life, GU (genitourinary) and GI (gastrointestinal) scales(Baseline, 1-month post-RT, every 3 months till 2-years post-RT)
研究者
NINGNING LU
Principal Investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences