A Randomized Phase III Study of Comparison Between Simultaneous Integrated Boost (SIB) Intensity-modulated Radiation Therapy (IMRT) Versus Routine IMRT/VMAT in LD-SCLC
试验速览
- 阶段
- 3 期
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- progress-free survival
研究概览
简要总结
Thoracic radiotherapy concurrent with chemotherapy stands for the standard regime for limited staged small cell lung cancer. Involved node radiation（INF） replaced elective node irradiation（ENI） as the more popular since several trails compared the two regimes. simultaneous integrated boost IMRT becomes mature with advancing in IMRT and VMAT. The investigator hypothesis that SIB-IMRT can confine the dose for organs at risk to reduce the toxicities compared with routine IMRT in limited disease small-cell lung cancer.
详细描述
All patients recruited divided into two arms：SIB-IMRT or routine IMRT，in the routine arm，the prescription dose was 60Gy/2Gy/30f，and in the SIB arm ，60Gy was given to the field of the tumor and metastatic lymph nodes，50Gy was given to CR lesion and high-risk prevention. The physical advantages of SIB-IMRT are to reduce the radiation dose of organs that are at risk in the lungs, esophagus, and heart ensuring the adequate dose for tumor area at the same time. The investigators are carrying out this trial to compare the efficacy, safety, side effects, and type of failure of the two radiotherapy techniques, which will provide a new choice and reliable basis for the future dose-segmentation study of limited-stage small-cell lung cancer.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-70 years old,KPS≥80
- •pathological small cell lung cancer
- •staged as limited disease SCLC（contralateral hilar invasion not included）
- •receive radiotherapy concurrent or sequential with chemotherapy，if induction chemotherapy，got PR or SD
- •no other tumors
- •No serious medical diseases and dysfunction of major organs
- •understand this study，able to complete the treatment，accept the following up and sign the informed consent
- •Contraception in women of childbearing age.
排除标准
- •other malignant tumor（historically or simultaneously）curable non-melanoma skin cancer and cervical carcinoma in situ not included
- •Uncontrolled heart disease or myocardial infarction within 6 months
- •History of mental illness
- •Pregnancy or Lactation
- •uncontrolled diabetes、hypertension
结局指标
主要结局
progress-free survival
时间窗: 2 year
the rate of patients survival from the treatment to death or progress
次要结局
- overall survival(2 year)
- local control rate(2 year)
- side-effects(3-6months after radiation)
研究者
Zongmei Zhou
Clinical Professor
Chinese Academy of Medical Sciences