Phase II Protocol for Risk-adapted Stereotactic Body Radio Therapy for Stage T1-T3N0 Non-Small Cell Lung Carcinoma
试验速览
- 阶段
- 2 期
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Toxicity of grade 3+ as assessed by NCI CTCAE v4.0
研究概览
简要总结
The purpose of this study is to perform prospective data analysis on tumor response in terms of local tumor control after 2 years, potential acute and late toxicity and survival in patients with non-metastatic, non-small-cell lung cancer treated by radiotherapy that are medically inoperable due to coexisting comorbidities or that refuse surgery. SBRT regimens used will be 4 fractions of 12 Gy or 3 fractions of 17 Gy depending on tumor location in a risk-adapted approach.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stage T1,T2,T3N0M0 NSCLC, histological confirmation either by biopsy or cytology
- •Maximal tumor diameter of 6 cm
- •Only T3 lesions based upon thoracic wall involvement, only 1 lesion
- •Informed consent is required
- •Life expectancy of at least 6 months
- •Age >/= 18 y.
- •Karnofsky score ≥ 70 or ECOG score ≤ 2
- •Inoperable patients or patients refusing surgery
- •Patients with measurable lesion (according to RECIST criteria)
排除标准
- •Diagnosis of small cell lung cancer
- •Lymph node involvement
- •Prior radiotherapy to the chest and/or mediastinum
- •No chemotherapy and/or targeted treatment within 3 months before SBRT
- •Pregnant or lactating women
- •Known allergy for CT contrast
- •Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
- •Patient unlikely to comply with protocol, i.e., uncooperative attitude, inability to return for follow-up visits, extreme degradation of lung function tests and patients not likely to complete the study.
结局指标
主要结局
Toxicity of grade 3+ as assessed by NCI CTCAE v4.0
时间窗: From start of SBRT until 1 year. After 1 year until end of follow-up for late toxicity
To monitor potential toxicity in patients with stage T1,T2,T3 N0 non-small cell lung carcinoma (NSCLC), treated with primary stereotactic body radiation therapy (SBRT)
次要结局
- Time to local progression(every 3 months for the first 2 years. From 3 to 5 years every 6 months. After From start of SBRT until date of death, regional fialure of last follow-up. Aanalysis occurs when all patients have been potentially followed for 24 months.)
研究者
Christine Collen, MD.
Radiaton Oncologist
Universitair Ziekenhuis Brussel