Multicenter Prospective Study of the Efficacy of Stereotactic Lung Radiation Therapy After Concomitant Radio-chemotherapy for Unresectable Stage III Non-small Cell Lung Carcinoma (NSCLC) With Peripheral Primary Tumor.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 4
- 主要终点
- Local control rate
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of stereotactic lung radiation therapy after concomitant radiochemotherapy for unresectable stage III non-small cell lung carcinoma (NSCLC) with peripheral primary tumor.
Evaluate in terms of local control rate at 6 months the addition of stereotactic radiotherapy after concurrent chemoradiotherapy in the treatment of mediastinal non-resectable stage III NSCLC having a peripheral primary tumor.
The number of patients required in this multicenter prospective study is 70.
This is a prospective, multicenter, non comparative and non randomized study.
详细描述
Stereotactic radiotherapy or SBRT (Body Stereotactic Radiation Therapy) allows to irradiate with high dose limited lesions size with a local control surrounding of 80-98% and with a low level of toxicity.
We propose to realize a classic concomitant RT-CT for mediastinal irradiation and combine this treatment with stereotactic RT for peripheral primary tumor.
The estimated inclusion period is approximately 3 years.
Follow-up duration for each patient is 2 years. The duration of the research is 5 years.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years ≤ Age ≤ 75 years
- •PS ECOG 0 or 1
- •Histologically proven NSCLC
- •Unresectable stage III: T1 or T2 or T3 ≤ 5 cm AND N2 or N3 (only contralateral mediastinum or homolateral supraclavicular).
- •Peripheral primary tumor ≥ 1 cm and ≤ 5 cm
- •Possible concomitant chemoradiotherapy : 1 cure induction and 3 concomitant cycles of chemotherapy with cisplatin and Navelbine ® and 3D conformal radiotherapy delivering 66 Gy in 33 fractions to the mediastinal lymph node involvement without treating the peripheral tumor.
- •Adequate biological parameters
- •Forced expiratory volume (FEV) ≥1 liter or ≥ 30% of the theoretical value
- •Patient covered by a health insurance scheme
- •Signed informed consent
排除标准
- •SCLC or large cell neuroendocrine carcinoma
- •Metastatic disease
- •Stage IVa
- •Pregnant or breast-feeding women
结局指标
主要结局
Local control rate
时间窗: 6 months after the end of SBRT
According to RECIST v1.1
次要结局
- Overall survival(From date of inclusion until the date of death from any cause, assessed up to 24 months after the end of SBRT)
- Progression-free survival(From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months after the end of SBRT)
- Safety (adverse events, assessed using the NCI-CTCAE v4 grading scale)(Up to 2 years after the end of SBRT)