Concurrent Chemo-Radiotherapy for Limited Disease Small Cell Lung Cancer (LD-SCLC) on Basis of FDG-PET-Scans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- isolated Nodal Recurrences
研究概览
简要总结
Our group has shown that the omission of elective nodal irradiation on the basis of CT scans in patients with LD-SCLC lead to a higher than expected isolated nodal recurrence in the ipsilateral supraclavicular area. We have previously also shown that selective mediastinal nodal radiation on basis of FDG-PET scans in NSCLC is safe and reduces the radiation fields and hence toxicity. As the accuracy of FDG-PET scans is also in SCLC higher than CT, we will investigate the safety of selective nodal irradiation in LD-SCLC patients treated with concurrent chemo-radiation.
详细描述
Eligible patients (see below) will receive radiotherapy to the primary tumor and the initially involved mediastinal lymph nodes on FDG-PET scan to a dose of 45 Gy in 30 fractions in 3 weeks (1.5 Gy BID with minimum 6 h interfraction interval).
Dose-constraints: MLD > 20 Gy. In that case, CT-based replanning will be done after 1 week of treatment and shrinking field techniques will be used if appropriate.
The radiation doses will be specified according to ICRU 50. Lung density corrections will be applied, as well as all standard QA procedures. Technical requirements are the same as in standard practice at MAASTRO clinic.
Radiotherapy shall start during the first cycle of carboplatin and etoposide chemotherapy.
Chemotherapy (standard schedule in the Comprehensive Cancer Centre Limburg region):
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Histological or cytological proven SCLC
- •UICC stage I-III, "limited disease"
- •Performance status 0-2
- •FeV 1 and DLCO at least 30% of the age-predicted value
排除标准
- •Not SCLC or mixed SCLC and other histologies (e.g. non-small cell lung carcinoma)
- •UICC stage IV
- •Performance status 3 or more
- •FeV 1 and DLCO < 30% of the age-predicted value
结局指标
主要结局
isolated Nodal Recurrences
时间窗: 18 months post-treatment
次要结局
- overall survival(18 months post-treatment)
- progression-free interval(18 months post-treatment)
- dyspnea (CTCAE 3.0)(18 months post-treatment)
- dysphagia (CTCAE 3.0)(18 months post-treatment)
- patterns of recurrence(18 months post-treatment)