Once-daily Simultaneous Modulated Accelerated Thoracic Radiotherapy Compared With Twice-daily Radiotherapy in Limited Small-cell Lung Cancer Treated Concurrently With Cisplatin and Etoposide
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- progression-free survival
研究概览
简要总结
This Phase II randomized study is to determine whether once-daily simultaneous modulated accelerated thoracic radiotherapy (RT) resulted in better survival than twice-daily RT for patients with limited-stage small-cell lung cancer (LD-SCLC).
详细描述
This Phase II randomized study is to determine whether once-daily (qd)simultaneous modulated accelerated thoracic radiotherapy resulted in better survival than twice-daily(bid) RT for patients with limited-stage small-cell lung cancer (LD-SCLC).
All patients receive four to six cycles of etoposide and cisplatin (EP) every 3 weeks. Thoracic RT is initiated with cycle 1-3 of chemotherapy. Qd RT includes the delivery of 65 Gy in 26 fractions delivered on weekdays for a total of 33 days. Bid RT includes the delivery of 45 Gy in 30 fractions delivered on weekdays for a total of 19 days. After the chest RT and the last cycle of EP, prophylactic cranial irradiation is administered to those patients with a complete or partial remission.
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
- •Pathologic confirmation of SCLC. Imaging studies' confirmation of limited stage.
- •No previous chest radiotherapy, chemotherapy or biotherapy.
- •Patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- •White blood cell count ≥4×109 /L, platelet count≥100×109 /L, hemoglobin ≥100 g /L; serum creatinine and total bilirubin 1.5 times or less the upper limits of normal (ULN), aspartate aminotransferase two times or less the ULN.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Weight loss ≤10% within the past 3 months.
- •Forced expiratory volume in 1 s >1 L.
排除标准
- •Previous or recent another malignancy.
- •A myocardial infarction within 6 months or had uncontrolled congestive heart failure, uncontrolled arrhythmia.
- •Malignant pleural or pericardial effusion.
- •Pregnant or Lactating.
- •Weight loss >10% within the past 3 months.
- •Drug addiction, long-term alcohol abuse and AIDS patients.
研究组 & 干预措施
q.d. RT
q.d. RT (65 Gy in 26 fractions) to the chest and concurrent etoposide and cisplatin
干预措施: etoposide and cisplatin (Drug)
q.d. RT
q.d. RT (65 Gy in 26 fractions) to the chest and concurrent etoposide and cisplatin
干预措施: q.d. RT (Radiation)
b.i.d.RT
b.i.d.RT (45Gy in 30 fractions) to the chest and concurrent etoposide and cisplatin
干预措施: b.i.d.RT (Radiation)
b.i.d.RT
b.i.d.RT (45Gy in 30 fractions) to the chest and concurrent etoposide and cisplatin
干预措施: etoposide and cisplatin (Drug)
结局指标
主要结局
progression-free survival
时间窗: 2 years
次要结局
未报告次要终点
研究者
Hui Liu
Professor
Sun Yat-sen University