PRophylactic Cerebral Irradiation or Active MAgnetic Resonance Imaging Surveillance in Small-cell Lung Cancer Patients (PRIMALung Study)
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Limited Stage Small Cell Lung Cancer
- 发起方
- European Organisation for Research and Treatment of Cancer - EORTC
- 入组人数
- 600
- 试验地点
- 41
- 主要终点
- Overall survival
- 状态
- 招募中
- 最后更新
- 2年前
概览
简要总结
In this phase III study, the primary objective is to test with a one-sided significance of 5% whether for the treatment of small cell lung cancer (SCLC) patients, brain MRI surveillance alone is non-inferior in terms of overall survival compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the entire study population.
详细描述
The primary objective is to test with a one-sided significance of 5% whether for the treatment of small cell lung cancer (SCLC) patients, brain MRI surveillance alone is non-inferior in terms of overall survival compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the entire study population under the treatment policy strategy. The secondary objectives are: * To test with a one-sided type I error of 2.5% whether brain MRI surveillance is superior in terms of cognitive failure free survival (CFFS) compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the study population. * To test with a one-sided type I error of 2.5% whether brain MRI surveillance is superior in terms of global health status/QoL and cognitive functioning according to EORTC QLQ-C30 questionnaire compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the study population. * To evaluate the frequency and severity of toxicities according to CTCAE v5.0 in the two arms in the treated population (i.e. patients who have started treatment). The exploratory objectives are: * To compare OS and CFFS between the arms within the subgroups of patients with LS and ES disease. * To compare OS and CFFS between the arms within the subgroups: HA-PCI or not, first-line immunotherapy or not, memantine or not. * To compare cognitive failure free survival (CFFS) rate at 12 months after randomization between the arms. * To compare the cumulative incidence of cognitive failures with death as a competing risk between the arms. * To compare brain-metastasis-free survival (BMFS) between the arms. * To compare progression free survival (PFS) between the arms. * To compare time to brain-metastasis-attributed death (TBMAD) between the arms. * To compare other QoL scales according to EORTC QLQ-C30 and QLQ-BN20 questionnaires between arms. * To evaluate the cost-effectiveness of MRI surveillance alone versus MRI surveillance combined with PCI. * To collect blood for biobanking.
研究者
入排标准
入选标准
- •Age ≥ 18 years
- •Histologically/cytologically proven diagnosis of SCLC
- •Limited and extensive stage
- •LS SCLC: Stage I-III (T any, N any, M0, according to UICC TNM staging v8.0) that can be safely treated with definitive radiation doses. Excludes T3-4 due to multiple lung nodules that are too extensive or have tumour/nodal volume that is too large to be encompassed in a tolerable radiation plan.
- •ES SCLC: Stage IV (T any, N any, M 1a/b), or T3-4 due to multiple lung nodules that are too extensive or have tumour/nodal volume that is too large to be encompassed in a tolerable radiation plan.
- •Completed standard therapy prior to randomization:
- •For patients with LS-SCLC, this includes a combination of 4-6 cycles of platinum-based doublet chemotherapy and either definitive thoracic radiotherapy (including SBRT for early-stage T1-2 N0 M0 disease who do not undergo surgery) or definitive surgical resection; thoracic radiation in addition to definitive surgical resection is allowed at the discretion of the treating physician, but is not mandated.
- •For patients with ES-SCLC, this includes 4-6 cycles of platinum-based doublet chemotherapy either with or without thoracic radiotherapy
- •o Immunotherapy concurrent with and/or adjuvant to standard therapy is allowed at the discretion of the treating physician.
- •Absence of progressive disease after completed standard therapy on systemic imaging (computed tomography (CT) or magnetic resonance imaging (MRI) of Chest/Abdomen/Pelvis and brain MRI), 28 days before randomization.
排除标准
- •Prior radiotherapy to the brain or whole brain radiotherapy. Note: Patients who have undergone prior stereotactic radiosurgery for benign tumours or conditions (e.g., acoustic neuroma, grade I meningioma, trigeminal neuralgia) may be considered on a case-by-case basis. Discussion with EORTC Headquarters is mandatory, before the randomization.
- •Known contraindication to imaging tracer or any product of contrast media, such as allergy or insufficient renal function. Known contraindication to MRI, such as implanted metal devices or foreign bodies.
- •Other active hematologic or solid tumour malignancy requiring current active treatment.
- •Any unresolved toxicities from prior therapy (e.g., chemotherapy, radiotherapy) greater than CTCAE grade 2 (according to CTCAE v5.0) at the time of randomization.
- •Patient with severe active comorbidities, defined as follows:
- •Unstable angina and/or congestive heart failure requiring hospitalization within 6 months prior to randomization
- •Transmural myocardial infarction within 6 months prior to randomization
- •Acute infection requiring treatment at the time of randomization
- •Chronic obstructive pulmonary disease exacerbation or other acute respiratory illness precluding study therapy at the time of randomization
- •Severe hepatic disease defined as a diagnosis of Child-Pugh class B or C hepatic disease
结局指标
主要结局
Overall survival
时间窗: 12 Months
The primary objective is to test with a one-sided significance of 5% whether for the treatment of small cell lung cancer (SCLC) patients, brain MRI surveillance alone is non-inferior in terms of overall survival compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the entire study population
次要结局
- cognitive failure free survival(12 Months)
- Quality of Life(12 Months)
- Safety profiling(12 Months)