HERAN2 Heterogeneously Hypofractionated Radiotherapy for Locally Advanced NSCLC A Randomised Multicentre Phase II Feasibility Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 182
- 主要终点
- OS at 12 months after randomization
研究概览
简要总结
Aim To test if proton therapy can improve survival compared to photon therapy in patients with locally advanced NSCLC who are not candidates for standard definitive chemo-radiotherapy.
Hypothesis The trial hypothesis is that proton therapy is less toxic than photon therapy in fragile patients and that this difference will mitigate to a difference in overall survival.
Design Multicentre, randomized phase II study 1:1 Sample size 182 patients (91 in each arm) Treatment Radiotherapy (inhomogeneous dose distribution) 50 Gy/ 24 fraction Endpoint Primary: Overall survival at 12 months Secondary: progression free survival, time to loco-regional and distant failure, pattern of failure, acute and late toxicity, quality of life, patient compliance.
详细描述
Study aim To evaluate whether a heterogeneous and hypo-fractionated definitive radiotherapy schedule delivered using proton (PT) can improve OS compared to photon (XT) in patients with LA_NSCLC not candidates for standard, long-course chemo-radiotherapy.
Primary endpoint
- OS at 12 months Secondary endpoints
- Progression-free survival
- Time to loco-regional failure
- Time to distant failure
- Pattern of failure
- Acute toxicity
- Late toxicity
- Persistent acute grade 2 or higher lung or esophageal toxicity
- Radiotherapy compliance
- Hospitalization during and up to 6 months after treatment
- Patient reported outcome measures at base-line and during follow-up Exploratory endpoints
- Heart toxicity evaluated by changes in cardiac biomarkers
- Changes in lymphocyte counts
Study design The study is designed as a prospective randomized multicentre phase II study. It includes patients with inoperable locally advanced NSCLC (stage IIB-IIIB) not candidates for standard concomitant chemotherapy. Patients are treated with radiotherapy in 24 fractions, 5 fractions a week. Dose prescription is inhomogeneous with 50 Gy to the clinical target volume (CTV).
Patients will be randomized 1:1 between XT or PT. It will thus be open-label to the patient and the treating physicians.
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
- •Histological or cytological confirmed LA_NSCLC
- •Not candidate for definitive chemo-radiotherapy
- •Performance status 0-2
- •Signed informed consent
- •Able to comply with study and follow-up procedures
排除标准
- •Prior radiotherapy to the thorax unless there is no significant overlap of current treatment volumes with previous treatment fields.
- •Uncontrolled other malignant disease.
- •Pregnancy
结局指标
主要结局
OS at 12 months after randomization
时间窗: 12 month after patient randomization
Overall survival 12 months after randomization
次要结局
- Changes in level of ctDNA(within 12 months after patient randomization)
- Changes in level of cardiac biomarkers (BNP)(12 month after patient randomization)
- Changes in level of cardiac biomarkers (TnT)(12 month after patient randomization)
- Acute toxicity(9 months after patient randomization)
- Progression free survival(up to 5 years after patient randomization)
- Changes in level of lymphocyte counts(12 month after patient randomization)
- Late toxicity(Up to 5 years after patient randomization)
- Pattern of faillure(up to 5 years after patient randomization)
- Changes in level of cardiac biomarkers (TnI)(12 month after patient randomization)
研究者
Tine Schytte
Professor, Consultant
Odense University Hospital