Combined Stereotactic Radiotherapy and Conventional Fractionation in Stage II and III Non Small Cell Lung Cancer (NSCLC) With Peripheral Tumors Smaller Than 5 cm
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- The mean-lung dose that is associated with a 15% probability of dose limiting toxicity, defined according to the CTCAE v4; radiation pneumonitis ≥ grade 3 and radiation induced dyspnea ≥ grade 3.
研究概览
简要总结
A phase I trial is being conducted in patients with inoperable locally advanced NSCLC to treat with a combination of Conventional Fractionated Radiotherapy (CFRT) on the mediastinal lymph nodes and Stereotactic Ablative Radiotherapy (SABR)on the primary tumor with concurrent chemotherapy. It is hypothesized that this will lead to an increase of local control and overall survival
详细描述
In locally advanced NSCLC local control has been poor, but with SABR remarkable high local control rates with low toxicity have been reported. Currently stage III and inoperable II NSCLC patients have been treated with IMRT and concurrent chemotherapy at out institute. In this study we will explore the combination of SABR and CFRT with concurrent chemotherapy
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
- All
- 接受健康志愿者
- 否
入选标准
- •Cytological or histological proven NSCLC stage III or inoperable stage II, cT1-2a-3N1-3M0 with peripheral tumors < 5 cm (chest wall infiltration is no exclusion criteria if the tumor diameter is < 5 cm).
- •Weight loss < 10% in the last three months
- •WHO-performance status ≤ 2
- •Patients that receive concurrent chemoradiotherapy, with the exception of adriamycin and gemcitabine
- •FEV1 and DLCO > 40 % of the age-adjusted normal value
- •Minimum required laboratory data bone marrow reserve and hepatic- and renal function
- •Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- •Before patient registration, written informed consent must be given according to GCP and national regulations
- •Exclusion criteria:
- •Patients with central tumors < 2 cm of the proximal bronchial tree (Figure 2) or tumors immediately adjacent to mediastinal or pericardial pleura.
- •Patients that receive sequential chemoradiotherapy or radiotherapy only.
- •Patients with grade 3 dyspnea at baseline (according to CTCAE version 4.03)
- •Patients with Pancoast tumors
- •Prior radiotherapy treatment to the thorax
- •Any contraindications to the administration of thoracic radiotherapy
- •Pregnant women
排除标准
- 未提供
研究组 & 干预措施
Radiation
combined CFRT and SABR with concurrent cisplatin
干预措施: SABR (Radiation)
Radiation
combined CFRT and SABR with concurrent cisplatin
干预措施: Cisplatin (Drug)
结局指标
主要结局
The mean-lung dose that is associated with a 15% probability of dose limiting toxicity, defined according to the CTCAE v4; radiation pneumonitis ≥ grade 3 and radiation induced dyspnea ≥ grade 3.
时间窗: 2 yrs
次要结局
未报告次要终点