NCT00727350Unknown2 期
Phase II Protocol for Primary Fractionated Stereotactic Body Radiation Therapy for Stage T1 - T3N0 Non Small Cell Lung Carcinoma.
AZ-VUB2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2007年3月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- To monitor potential acute and late toxicity in patients with stage T1,T2,T3N0 non small cell lung carcinoma (NSCLC), treated with primary stereotactic body radiation therapy (SBRT).
研究概览
简要总结
The study population will exist of patients with a histological diagnosis of NSCLC, stage T1, T2 or T3NO who are not fit for or who refuse surgery. A prospective data analysis will be performed on tumor response, potential acute and late toxicity and survival. A radiotherapy dose of 4x15Gy or 3x 20Gy will be given over 2 weeks with dynamic 3D-conformal arc therapy (Novalis TM)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •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
- •Informed consent is required
- •Life expectancy of at least 6 months
- •Age > 18 y.
- •Karnofsky score ≥ 70 or ECOG score ≤ 1
- •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 or chemotherapy for lung cancer
- •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
To monitor potential acute and late toxicity in patients with stage T1,T2,T3N0 non small cell lung carcinoma (NSCLC), treated with primary stereotactic body radiation therapy (SBRT).
时间窗: Every 3 months for the first 2 years. From 3 to 5 years every 6 months. After 5 years follow-up will happen yearly.
次要结局
- Local control at 2 years. Overall survival, local progression free survival, disease free survival, time to progression and local,regional or disseminated recurrence.Quality of life. Internal and Intra-fractional tumor motion. Biopsy samples.(Every 3 months for the first 2 years. From 3 to 5 years every 6 months. After 5 years follow-up will happen yearly.)
研究者
研究点 (2)
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