Postoperative Radiotherapy of Non-small Cell Lung Cancer: Accelerated vs. Conventional Fractionation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 16
- 主要终点
- assessment of local tumor control
研究概览
简要总结
In this randomized multicentric phase II study it will be investigated whether an accelerated postoperative radiotherapy with photons or protons (7 fractions per week, 2 Gy single dose) may improve locoregional tumour control in non-small cell lung cancer (NSCLC) in comparison to conventional fractionation (5 fractions per week, 2 Gy single dose).
详细描述
This study is a randomized multicentric trial. Within this study an accelerated irradiation schedule (7 fractions per week, 2 Gy single dose) will be compared with the currently used conventional fractionation schedule (5 fractions per week, 2 Gy single dose) for postoperative radiotherapy with photons or protons in patients with NSCLC. The primary endpoint is locoregional tumour control after 36 months. Secondary endpoints are overall survival of patients, local recurrence-free and distant metastases-free survival after 36 months, acute and late toxicity as well as quality of life for both treatment methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •histologically confirmed non-small cell lung cancer
- •previous tumor resection with curative intention
- •postoperative indication for irradiation (> pN1 and/ or R1)
- •R2-resection or recurrence postoperative/after adjuvant chemotherapy diagnosed by the restaging-imaging
- •exclusion of distant metastases (M0)
- •age > 18 years
- •good general condition (ECOG performance status 0 or 1)
- •written informed consent
- •appropriate compliance to ensure close follow-up
- •women of childbearing age: adequate contraception
排除标准
- •histologically confirmed small cell lung cancer
- •distant metastases
- •no written informed consent or lack of cooperation relating to therapy or follow-up
- •previous (< 5 years) or concomitant other malignant disease (exception: malignant disease, which is very likely healed and not influenced therapy or follow up of the non-small cell lung cancer, e.g. carcinoma in-situ, basaliomas, very early skin cancers)
- •for proton therapy: heart pacemaker
- •previous radiotherapy of the thorax or lower neck region
- •pregnancy or lactation
- •participation in another intervention study or not completed follow-up of a intervention study. Exceptions are psychological studies, supportive or observation studies, the previous therapy of non-small cell lung cancer is in accordance with the guideline and the participation in radiotherapy studies is not excluded in the trial protocol of the previous study
结局指标
主要结局
assessment of local tumor control
时间窗: 36 months after therapy
Local tumor control will be assessed by appropriate non-invasive (CT or PET-CT) and if necessary invasive examination methods (bronchoscopy with biopsy).
次要结局
- overall survival(36 months after therapy)
- local recurrence-free survival(36 months after therapy)
- acute toxicity(Comparison after 20, 50, 100 and 200 patients have been treated. This number of patients is expected to be included after 6, 12, 18 and 40 months.)
- quality of life(36 months after therapy)
- late toxicity(Comparison after 20, 50, 100 and 200 patients have been treated. This number of patients is expected to be included after 6, 12, 18 and 40 months.)
- distant metastases-free survival(36 months after therapy)
研究者
Dr. Rebecca Bütof
Principal Investigator
Technische Universität Dresden