ACTRN12614000478617进行中(未招募)2 期
Assessing the feasibility of Stereotactic Ablative Body Radiotherapy (SABR) for stage I Non-Small Cell Lung Cancer (NSCLC): A single arm prospective phase II non-randomized multicentre study
Dr Eric Hau0 个研究点目标入组 134 人开始时间: 2014年5月8日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 134
研究概览
简要总结
Collaborative Implementation of Stereotactic Ablative Body Radiotherapy - A model for the safe implementation of complex radiotherapy techniques in Australia
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit(—)
- 性别
- All
入选标准
- •Diagnosis of non-small cell lung cancer
- •-Pathological diagnosis is desirable where this can be achieved.
- •-Diagnosis based on imaging: requires evidence that lesion(s) are increasing in size on 2 consecutive CT scans and /or increased uptake on PET.
- •Stage T1-T2, N0M0 (AJCC Staging, 6th ed.) with tumour size less than or equal to 5 cm, based upon:
- •-History and physical examination 4 weeks prior to registration.
- •-CT chest, abdomen and pelvis and/or
- •-FDG PET-CT scan
- •ECOG performance status of less than or equal to 2
- •Patients must be able to lie flat and comply with the requirements of simulation and treatment.
- •Patients with previous thoracic radiotherapy are permitted, provided V20 less than 15% on previous treatment an no overlap with intended current radiotherapy field
- •Patients with previous history of malignancy may be included provided the previous malignancy is in remission and after a MDT discussion the current lung lesion is thought to be more likely of lung primary rather than metastatic disease
排除标准
- •Pregnant women
- •Inability to lie flat and tolerate immobilization for duration of planning and treatment
研究者
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