A Multicenter Randomized Phase II Study of Stereotactic Hypofractionated Radiotherapy With Body Frame Versus Conventionally Fractionated Radiotherapy for Stage I Medically Inoperable Non-small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 102
- 主要终点
- Freedom from tumor progression
研究概览
简要总结
A randomized phase II study for medically inoperable stage I non-small cell lung cancer where stereotactic body radiotherapy in three fractions to 66 Gy is compared with conventionally fractionated radiotherapy to 70 Gy in 35 fractions.
详细描述
This is a multicenter Scandinavian randomized phase II study of stereotactic hypofractionated radiotherapy with body frame versus conventionally fractionated radiotherapy for stage I medically inoperable non-small cell lung cancer patients. There is a 1:1 randomization between arm A: Stereotactic radiotherapy to a dose of 66 Gy with 22 Gy per fraction at the isocenter (45 Gy covers the PTV) in 3 fractions during one week with body frame fixation and a planning target volume with a 5 mm margin around the macroscopic tumour, and arm B: Conventionally fractionated radiotherapy to a dose of 70 Gy with 2 Gy per fraction in 35 fractions during 7 weeks with fixation in a vacuum pillow and a planning target volume with a 2 cm margin around the macroscopic tumour.
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
- 接受健康志愿者
- 否
入选标准
- •Non-small cell lung cancer stage I: T1-2 N0 M
- •Medically inoperable patients or patients refusing surgery.
- •Morphologically verified. If that is impossible there must be increased tumour size in repeated CT scans and positive PET.
- •Patients should have a life expectancy of > 6 months.
- •WHO performance status 0-
- •Signed written informed consent obtained.
- •Patient should be feasible for both study arms.
排除标准
- •Patients with central tumour growth adjacent to trachea, main bronchus or esophagus.
- •Maximal tumour diameter > 6 cm.
- •Patients with prior malignancy within the last five years (except basal cell carcinoma of the skin or in situ carcinoma of the cervix).
- •Any prior antitumoral treatment of the present lung cancer.
- •Previous irradiation that included part of the lung.
- •Pregnant women.
结局指标
主要结局
Freedom from tumor progression
时间窗: At 36 months after randomization
complete remission,partial remission or stable disease
次要结局
- Overall survival(At 36 monts after randomization)
研究者
Ass. Prof. Jan Nyman
Ass. Prof. Jan Nyman
Swedish Lung Cancer Study Group