NL-OMON40781撤回2 期
ungTech Stereotactic Body Radiotherapy (SBRT) of inoperable centrally located NSCLC: A phase II study in preparation for a randomized phase III trial - LungTech
European Organisation for Research in Treatment of Cancer (EORTC)0 个研究点目标入组 42 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 42
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Diagnosis of non-metastatic NSCLC, confirmed by either histology or cytology.
- •- Centrally located tumor defined as tumor within 2 cm or touching the zone of the proximal bronchial tree or tumor that is immediately adjacent to the mediastinal or pericardial pleura, with a PTV expected to touch or include the pleura.
- •- Patient deemed medically inoperable after assessment in a multimodality tumor board or refusing surgery.
- •- Tumor size * 7 cm (T1-T3 N0 according to UICC 7th Edition 2011).
- •- T3 tumors will be accepted only if one lesion and not abutting the oesophagus.
- •- Whole body FDG-PET scan acquired before inclusion, combined with either
- •whole body CT or CT of chest and upper abdomen. In case of uncertainty about involvement of hilar/mediastinal nodes, endobronchial ultrasound-transbronchial needle aspiration (EBUS-TBNA) is strongly recommended
- •- Expert central review of all staging FDG-PET/CT images before inclusion by an experienced radiation oncologist and a PET/CT specialist.
- •- Treatment must be planned to start within 6 weeks of FDG-PET/CT.
- •- No prior radiotherapy to chest and/or mediastinum
- •- No chemotherapy and/or targeted treatment within 3 months before the start of SBRT
- •- WHO performance status * 2
- •- Age * 18 years
- •- Patients of childbearing / reproductive potential should use adequate birth control measures, during the study treatment period. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly.
- •- No other malignancy except adequately treated basal cell carcinoma of the skin or other malignancy from which the patient has been disease free for at least 5 years.
- •- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- •- Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations
排除标准
- •- Women must not be pregnant
研究者
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