Local Non-salvage Radiotherapy for Synchronous Oligometastatic Non-small-cell Lung Cancer :A Multicenter,Randomized,Controlled,Phase 2 Study.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
Aggressive therapy may improve survival in synchronous oligometastatic NSCLC and the goal of this clinical trial is to assess the efficacy and safety of local definitive radiotherapy in this subset of patients.
详细描述
For NSCLC patients with synchronous oligometastases, first line chemotherapy or targeted therapy concurrent with non-salvage radiotherapy on metastatic or primary thoracic tumor contributed a longer progression-free survival than chemotherapy or targeted therapy alone.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18 to 70 years old;
- •Histologically or cytologically confirmed non-small cell lung cancer;
- •Stage IV patients with measurable primary tumor and distant metastases number ≤5；
- •PS score 0-2；
- •Have never received local or systemic anti-cancer treatment, including surgery (biopsy is allowed), first line chemotherapy, targeted therapy or immunotherapy;
- •Life expectancy of >3 months;
- •Organ function levels must meet the following requirements:
- •(1)Bone marrow: White blood cell (WBC)≥4.0G/L；neutrophile granulocyte (NEU)≥1.5G/L；platelets (PLT)≥100G/L; hemoglobin (HGB)≥9g/L； (2)Liver and kidney: total bilirubin (TBIL), aspartate aminotransferase (AST), alanine aminotransferase (ALT)≤2.0 × the upper limit of normal (ULN)；creatinine≤1.5×ULN; 8.Patient must be willing and able to provide written informed consent.
排除标准
- •The amount of metastatic focus >5;
- •Patient can't tolerate chemotherapy or targeted therapy;
- •Local or systemic anti-cancer treatment had been used for the primary foci and metastatic lymph nodes, including surgery (biopsy is allowed), first line chemotherapy, targeted therapy or immunotherapy;
- •Previous or concurrent suffered from other malignancies;
- •Concurrent with other serious disease that can not be controlled;
- •Women who are breast-feeding or pregnant;
- •Have an allergy to pemetrexed, cisplatin, taxanes, targeted medicine and contrast agent;
- •Patients with poor obedience or researchers think that the patient may not be able to accomplish the whole trial.
研究组 & 干预措施
Local Definitive Radiotherapy
Standard platinum-based doublet chemotherapy or EGFR-TKI (Gefitinib or Erlotinib) followed by 3D-CRT (three-dimensional conformal radiotherapy) or IMRT (intensity modulated radiotherapy) to primary thoracic foci or remediable oligometastatic focus.
干预措施: Local Definitive Radiotherapy (Radiation)
Local Definitive Radiotherapy
Standard platinum-based doublet chemotherapy or EGFR-TKI (Gefitinib or Erlotinib) followed by 3D-CRT (three-dimensional conformal radiotherapy) or IMRT (intensity modulated radiotherapy) to primary thoracic foci or remediable oligometastatic focus.
干预措施: No Local Definitive Radiotherapy (Drug)
No Local Definitive Radiotherapy
Standard platinum-based doublet chemotherapy or EGFR-TKI (Gefitinib or Erlotinib) alone, according to gene test.
干预措施: No Local Definitive Radiotherapy (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: 5 years
Refers to the time from randomization to disease progression or death.
次要结局
- Local tumor control(up to 5 years)
- Oligometastatic foci control(up to 5 years)
- Thoracic Progression Free Survival(up to 5 years)
- Overall Survival(up to 5 years)
研究者
Xiaoxia Zhu
Professor
Southern Medical University, China