Lung Microcytoma Extensive Disease: Prospective Study of Association of Thoraco-mediastinal Radiotherapy With Maintenance Immunotherapy Treatment With Atezolizumab
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Evaluate the efficacy of the association between radiotherapy and immunotherapy
研究概览
简要总结
Investigate the role of consolidative radiotherapy treatment at the thoraco-mediastinal level in the patient suffering from lung microcytoma - extensive disease and treated with chemo-immunotherapy with atezolizumab, in association with maintenance therapy with atezolizumab.
详细描述
Prospective phase II study on patients affected by extensive-stage small cell lung cancer. The traditional treatment of lung microcytoma-extensive disease consists in platinum and etoposide-based chemotherapy. Radiotherapy of consolidation at the thoracic mediastinal level after chemotherapy may have an impact on survival and can be offered to patients in response to chemotherapy. Studies have recently shown that the addition of immunotherapy with atezolizumab to traditional chemotherapy improves survival compared to placebo. However, the use of consolidation radiotherapy was not permitted in the study thoracic level. Therefore the objective is to evaluate the efficacy and tolerance of the thoracic radiotherapy-immunotherapy association in the maintenance phase with atezolizumab of the treatment of lung microcytoma - extensive disease treated with chemo-immunotherapy.
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
- •Histological diagnosis of lung microcytoma;
- •Age ≥18 years;
- •Performance status according to ECOG 0-2;
- •Extended disease at the time of first line oncological treatment;
- •Initial staging and restaging after chemo-immunotherapy with CT, CT-PET FDG and brain MRI;
- •In at least partial response (defined according to the Recist criteria [18]) after treatment chemoimmunotherapy according to the Impower 133 scheme;
- •Haematological, respiratory toxicity ≤ G1, other toxicities ≤ G2 at the time of treatment radiotherapy;
- •Pulmonary function tests at the time of radiotherapy treatment compatible with irradiation: FEV≥1.2 l or >40%, DLCO≥50%;
- •Written informed consent.
排除标准
- •Previous radiotherapy treatment at the thoraco-mediastinal level;
- •In disease progression after chemo-immunotherapy treatment.
研究组 & 干预措施
Thoracic radiotherapy-immunotherapy association in maintenance phase with atezolizumab
Patients enrolled during the maintenance phase of chemoimmunotherapy treatment (standard of care) according to the IMPOWER 133 scheme which is divided as follows: 1) initial chemo-immunotherapy phase with IV treatment cycles with carboplatin AUC 5 day 1 and etoposide 100 mg/m2 days 1-3 q21 followed by a maintenance phase with immunotherapy (Atezolizumab day 1 1200 mg i.v. g1 of each cycle) until progression-toxicity.
In association with immunotherapy, all patients will undergo treatment radiotherapy with 45 Gy in 15 fractions of 3 Gy administered 5 days a week on residual disease documented on CT-PET, dose 32.5Gy (2.16Gy for 15 fractions) on lymph node sites in response complete, equivalent to (EQD2 alpha beta 10) at 30 Gy in 3 fractions.
干预措施: Thoracic radiotherapy (Radiation)
Thoracic radiotherapy-immunotherapy association in maintenance phase with atezolizumab
Patients enrolled during the maintenance phase of chemoimmunotherapy treatment (standard of care) according to the IMPOWER 133 scheme which is divided as follows: 1) initial chemo-immunotherapy phase with IV treatment cycles with carboplatin AUC 5 day 1 and etoposide 100 mg/m2 days 1-3 q21 followed by a maintenance phase with immunotherapy (Atezolizumab day 1 1200 mg i.v. g1 of each cycle) until progression-toxicity.
In association with immunotherapy, all patients will undergo treatment radiotherapy with 45 Gy in 15 fractions of 3 Gy administered 5 days a week on residual disease documented on CT-PET, dose 32.5Gy (2.16Gy for 15 fractions) on lymph node sites in response complete, equivalent to (EQD2 alpha beta 10) at 30 Gy in 3 fractions.
干预措施: Atezolizumab 1200 mg e.v. q21 (Drug)
结局指标
主要结局
Evaluate the efficacy of the association between radiotherapy and immunotherapy
时间窗: 60 months
The local recurrence rate of the disease at one year will be evaluated, with the aim of considering a % greater than 49.9% as unacceptable, assuming that with the experimental treatment object of this study a % of local recurrences of 30% can be achieved. We will therefore test the hypothesis of a local recurrence rate \>50% vs the hypothesis of a local control \<30%. Assuming a power of 80% and a one-sided significance level of 5%, it will be necessary to enroll 37 patients; if 13 or fewer local recurrences are observed, the study will be considered positive.
次要结局
- Measuring the tolerability(60 months)