NCT06627738招募中2 期
Locally Advanced NSCLC Treated With Radiochemotherapy: Phase 2 Study on the Value of a Stereotactic Boost
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- To evaluate progression-free survival at 24 months after additional Cyberknife irradiation following concomitant radio-chemotherapy in patients with locally advanced non-small cell lung carcinoma (NSCLC).
研究概览
简要总结
This is a monocentric, non-randomized, open-label, superiority phase II clinical investigation evaluating the efficacy of additional Cyberknife irradiation after a doublet of Platinum Salts-based chemotherapy and concomitant radiotherapy in patients with locally advanced non-small cell lung carcinoma (NSCLC), with an interim analysis.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years old or more
- •ECOG 0 to 2
- •Histologically proven non-small cell lung cancer
- •Stage III non-metastatic tumor, not allowing for immediate surgery
- •Volume(s) on the evaluation chest CT scan done at the end of conventional radiotherapy (between 34 & 46 Gy) meeting the following criteria:
- •1 to 3 target volumes of less than 5 cm in greatest diameter
- •And allowing for the delivery of a CyberKnife boost to be carried out in compliance with the manufacturer requirements and with the doses delivered to the organs at risk (OAR/fractions) defined in appendix 2
- •Patients who have received a " Taxcis " treatment consisting in 2 cycles of induction chemotherapy (platinium-based doublet) and then at least 40 Gy of irradiation in combination with at least 2 cycles of concomitant chemotherapy (platinium-based doublet)
- •No contraindication to implantable venous devices (IVDs)
- •Patient who has read the patient information note and signed the consent form
- •If applicable, negative pregnancy test*
- •Eligible for National Health Insurance in France
- •Chest CT scan performed prior to Taxcis
排除标准
- •Positive EGFR mutation
- •Exercise-induced dyspnea associated with heart failure equal to or greater than stage III of the New York Heart Association (NYHA) classification, (appendix 3)
- •Coronary syndrome or heart failure in the last three months
- •Pulmonary function test contraindicating radiotherapy: PFT-FEV1 inferior to 1 L.
- •After radio-chemotherapy, presence of any toxicity contraindicating Cyberknife irradiation
- •Vulnerable populations and participants as defined in Articles 64 to 68 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017:
- •Incapacitated participants who have not given or refused informed consent prior to the onset of their incapacity, who are not under the provisions of article 64 ;
- •Pregnant or breast-feeding women who are not covered by the provisions of article 66 ;
- •Adults under legal protection or unable to express their consent.
结局指标
主要结局
To evaluate progression-free survival at 24 months after additional Cyberknife irradiation following concomitant radio-chemotherapy in patients with locally advanced non-small cell lung carcinoma (NSCLC).
时间窗: 24 months
Progression-free survival at 24 months will be assessed by calculating the time between the date of inclusion and the date of progression (according to RECIST 1.1 criteria) or death from any cause whichever come first. Patients who have not progressed, died or been lost to follow-up at the time of analysis will be censored at the date of last news.
次要结局
- Evaluate overall survival at 24 months and at 60 months(60 months)
- Evaluate specific survival at 24 months and at 60 months(60 months)
- Evaluate the efficacy of the additional Cyberknife irradiation following concomitant radio-chemotherapy at 24 months(24 months)
- Evaluate overall tolerability of the additional Cyberknife irradiation following concomitant radio-chemotherapy at 24 months(24 months)
- Evaluate overall survival at 24 months and at 60 months(60 months)
- Evaluate specific survival at 24 months and at 60 months(60 months)
- Evaluate the efficacy of the additional Cyberknife irradiation following concomitant radio-chemotherapy at 24 months(24 months)
- Evaluate overall tolerability of the additional Cyberknife irradiation following concomitant radio-chemotherapy at 24 months(24 months)
- Evaluate overall quality of life before Cyberknife, 1 month post-Cyberknife and 6 months post-Cyberknife(6 months)
研究者
研究点 (2)
Loading locations...
相似试验
进行中（未招募）
2 期
Multimodality Treatment in Stage III Non-small Cell Lung Cancer (NSCLC)NSCLCNon-small Cell Lung CancerNCT04245514Swiss Cancer Institute90
已完成
1 期
Combined CFRT and SABR in Stage II and III NSCLC With Peripheral Tumors Smaller Than 5 cm.Inoperable Locally Advanced Non Small Cell Lung CancerNCT01933568The Netherlands Cancer Institute15
已完成
2 期
Tetracycline as a Prophylaxis for Rash in Patients With NSCLC Receiving Treatment With BIBW2992 (Afatinib)Skin RashLung CancerNCT01880515Instituto Nacional de Cancerologia de Mexico107
Unknown
2 期
Hypofractionated Intensity Modulated Chemoradiotherapy to Treat Locally Advanced Non-Small Cell Lung CancerStage III Non-Small Cell Lung CancerNCT00938418National University Hospital, Singapore43
终止
1 期
Study in Patients With Advanced Non-Small Cell Lung Cancer Treated With Pemetrexed and Carboplatin Plus or Minus SorafenibCarcinoma, Non-Small-Cell LungNCT00473486University Hospital Muenster12