Role of Radiotherapy to the Primary Lesion in Metastatic Non-small Cell Lung Cancer Patients After First Line Systemic Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- progression free survival
研究概览
简要总结
study the effect of radiotherapy to the primary lesion after first line systemic therapy in metastatic non-small cell lung cancer patients.
详细描述
Metastatic non-small cell lung cancer patients after receiving their first line systemic therapy according to their genetic mutation will be randomized to follow up versus radiotherapy to the primary lesion.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed histological diagnosis of NSCLC.
- •Stage IV disease.
- •Patients with P.S ≤
- •finished at least 4 cycles of platinum-based doublet chemotherapy if patient has no diver mutation, or at least 3 months of anti-EGFR, Anti-ALK according to their driver mutation with SD, PR or CR.
排除标准
- •History of prior irradiation to the lung.
- •residual Malignant pleural or pericardial effusion at randomization time.
- •History of prior malignant tumor likely to interfere with the treatment protocol.
- •Severe comorbidities as measured by morbidity index.
- •Disease progression on first line systemic therapy.
研究组 & 干预措施
radiotherapy arm
after first line systemic therapy, patients will receive radiotherapy to the primary lesion, hypo-fractionated regimen 45gy will be given over 15 fractions
干预措施: first line systemic therapy (Drug)
radiotherapy arm
after first line systemic therapy, patients will receive radiotherapy to the primary lesion, hypo-fractionated regimen 45gy will be given over 15 fractions
干预措施: 3D radiotherapy or IMRT (Radiation)
no intervention arm
after first line systemic therapy, patients will be kept under follow up
干预措施: first line systemic therapy (Drug)
结局指标
主要结局
progression free survival
时间窗: six months
time from randomization till disease progression
patients quality of life
时间窗: six months
using the European Organization for Research and Treatment of Cancer core quality of life questionnaire, the EORTC QLQ-C30
次要结局
- overall survival(six months)
- patients pattern of failure(six months)
- patients toxicity(six months)
研究者
yostena nagy kamel mekhail
Principal Investigator
Menoufia University