The Prospective,Multicenter,Randomized Controlled Clinical Study of the Optimal Intervention Time of Radiotherapy for Oligometastatic Stage IV Non-small Cell Lung Cancer（NSCLC）
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 420
- 试验地点
- 1
- 主要终点
- short-term effects（The response rate，RR）
研究概览
简要总结
This study evaluates the optimal intervention time of radiotherapy for oligometastatic stage iv lung cancer.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 75 years old , male or female
- •Pathologically or cytologically proven oligometastatic stage IV NSCLC non-small cell lung cancer（NSCLC）
- •Primary tumors can be measured
- •Distant organ metastases number ≤ 5
- •Karnofsky score >70,Zubrod performance status 0-1
- •Estimated life expectancy of at least 12 weeks
- •reproductive age women should ensure that before entering the study period contraception
- •Hemoglobin≥10.0g/dL,WBC≥ 4000 cells/mm³,Platelet count≥100,000 cells/mm³
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 times upper limit of normal,bilirubin normal
- •Creatinine normal OR creatinine clearance ≥ 60 mL/min
- •Patients have good compliance to treatment and follow-up of acceptance.
排除标准
- •Allergic to pemetrexed, cisplatin, docetaxel and contrast medium
- •Distant metastases organs > 5
- •The primary tumor or lymph node already received surgical treatment (except for biopsy)
- •Patient who received radiotherapy for primary tumor or lymph node
- •Patient who received the the epidermal growth factor targeted therapy
- •Patient who received chemotherapy or immunotherapy
- •Patient who suffered from other malignant tumor
- •Patient who have taken other drug test within 1 month
- •Pregnant woman or Lactating Women and Women in productive age who refuse to take contraception in observation period
- •Subject with a severe allergic history or idiosyncratic
- •Subject with severe pulmonary and cardiopathic disease history
- •Refuse or incapable to sign the informed consent form of participating this trial
- •Drug abuse or alcohol addicted
- •Subject with a Personality or psychiatric diseases, people with no legal capacity or people with limited capacity for civil conduct
研究组 & 干预措施
Arm A
Patients receive concurrent chemoradiotherapy at first。Patients also receive chemotherapy every 3-4 weeks for two cycles after concurrent chemoradiotherapy.
chemotherapy：（1） squamous cell carcinoma：Docetaxel 60mg/m2 d1+Cisplatin 25mg/m2 d1-3.（2）non squamous cell carcinoma： pemetrexed 500mg/m2 d1+Cisplatin 25mg/m2 d1-3.
干预措施: concurrent chemoradiotherapy (Radiation)
Arm A
Patients receive concurrent chemoradiotherapy at first。Patients also receive chemotherapy every 3-4 weeks for two cycles after concurrent chemoradiotherapy.
chemotherapy：（1） squamous cell carcinoma：Docetaxel 60mg/m2 d1+Cisplatin 25mg/m2 d1-3.（2）non squamous cell carcinoma： pemetrexed 500mg/m2 d1+Cisplatin 25mg/m2 d1-3.
干预措施: Docetaxel (Drug)
Arm A
Patients receive concurrent chemoradiotherapy at first。Patients also receive chemotherapy every 3-4 weeks for two cycles after concurrent chemoradiotherapy.
chemotherapy：（1） squamous cell carcinoma：Docetaxel 60mg/m2 d1+Cisplatin 25mg/m2 d1-3.（2）non squamous cell carcinoma： pemetrexed 500mg/m2 d1+Cisplatin 25mg/m2 d1-3.
干预措施: pemetrexed (Drug)
Arm A
Patients receive concurrent chemoradiotherapy at first。Patients also receive chemotherapy every 3-4 weeks for two cycles after concurrent chemoradiotherapy.
chemotherapy：（1） squamous cell carcinoma：Docetaxel 60mg/m2 d1+Cisplatin 25mg/m2 d1-3.（2）non squamous cell carcinoma： pemetrexed 500mg/m2 d1+Cisplatin 25mg/m2 d1-3.
干预措施: Cisplatin (Drug)
Arm B
Patients receive neoadjuvant chemotherapy every 3-4 weeks for two cycles at first.Patients then receive concurrent chemoradiotherapy after neoadjuvant chemotherapy.
chemotherapy：（1） squamous cell carcinoma：Docetaxel 60mg/m2 d1+Cisplatin 25mg/m2 d1-3.（2）non squamous cell carcinoma： pemetrexed 500mg/m2 d1+Cisplatin 25mg/m2 d1-3.
干预措施: concurrent chemoradiotherapy (Radiation)
Arm B
Patients receive neoadjuvant chemotherapy every 3-4 weeks for two cycles at first.Patients then receive concurrent chemoradiotherapy after neoadjuvant chemotherapy.
chemotherapy：（1） squamous cell carcinoma：Docetaxel 60mg/m2 d1+Cisplatin 25mg/m2 d1-3.（2）non squamous cell carcinoma： pemetrexed 500mg/m2 d1+Cisplatin 25mg/m2 d1-3.
干预措施: Docetaxel (Drug)
Arm B
Patients receive neoadjuvant chemotherapy every 3-4 weeks for two cycles at first.Patients then receive concurrent chemoradiotherapy after neoadjuvant chemotherapy.
chemotherapy：（1） squamous cell carcinoma：Docetaxel 60mg/m2 d1+Cisplatin 25mg/m2 d1-3.（2）non squamous cell carcinoma： pemetrexed 500mg/m2 d1+Cisplatin 25mg/m2 d1-3.
干预措施: pemetrexed (Drug)
Arm B
Patients receive neoadjuvant chemotherapy every 3-4 weeks for two cycles at first.Patients then receive concurrent chemoradiotherapy after neoadjuvant chemotherapy.
chemotherapy：（1） squamous cell carcinoma：Docetaxel 60mg/m2 d1+Cisplatin 25mg/m2 d1-3.（2）non squamous cell carcinoma： pemetrexed 500mg/m2 d1+Cisplatin 25mg/m2 d1-3.
干预措施: Cisplatin (Drug)
结局指标
主要结局
short-term effects（The response rate，RR）
时间窗: 3 months after the end of the treatment
Response Evaluation Criteria In Solid Tumors (RECIST)
次要结局
- PFS（progression-free survival）(up to 3 years)
- esophagitis and pneumonitis(up to 3 years)
- Other grade 3-5 adverse events(up to 3 years)
- Quality of life (QOL)(up to 3 years)
研究者
LI TAO
Section Head
Sichuan Cancer Hospital and Research Institute