Randomized Phase III Study Comparing Different Thoracic Radiotherapy Regimens in Patients With Extensive Stage Small Cell Lung Cancer Who Respond to Chemotherapy
试验速览
- 阶段
- 不适用
- 入组人数
- 186
- 试验地点
- 2
- 主要终点
- overall survival
研究概览
简要总结
Most patients with extensive stage small-cell lung cancer (ES-SCLC) who undergo chemotherapy, and prophylactic cranial irradiation, have persistent intrathoracic disease. A Dutch study recently proved that thoracic radiotherapy(TRT), using 30 Gy in 10 fractions of 3 Gy, could improve 2-year overall survival(OS) of this patient group compared with non-TRT group. But intrathoracic progression was still high, either with or without progression elsewhere, occurring in 43.7% in the TRT group. The ideal TRT regimen for ES-SCLC is undefined. Maybe higher dose can provide better local control(LC) and overall survival. In this study, the investigators propose to give an increased dose of TRT to determine whether higher dose will improve 2-year OS, LC and progression-free survival.
详细描述
This is a multicenter, prospective, randomised phase III study. For patients with ES-SCLC who respond to chemotherapy after four to six cycles of standard chemotherapy (platinum etoposide), 45Gy/15F of thoracic radiotherapy will be used in experimental arm, while 30Gy/10F of thoracic radiotherapy will be used in the control arm. Both survival and toxicity of the two arms will be observed and compared.
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
- •18 - 70 years old, ECOG 0-
- •Patients with histologically or cytologically proved small cell lung cancer.
- •Extensive stage small-cell lung cancer (ES-SCLC), was characterized by tumors beyond the hemithorax, hilar, mediastinal, and supraclavicular nodes. According to 2007 AJCC cancer staging 7th edition, stage I-IIIB with lung metastases and stage IV should be defined as LD.
- •Has 1-4 extracranial metastatic lesions.
- •No brain or central nervous system (CNS) metastases.
- •No prior history of anti-tumor treatment.
- •Response after 4 to 6 cycles of EP-based chemotherapy within the past 4 weeks.
- •No severe internal diseases and no organ dysfunction.
- •Written informed consent provided.
排除标准
- •Malignant tumors of other sites. Non melanoma skin cancer and Cervical carcinoma in situ were not included if curable.
- •Active heart disease or acute myocardial infarction happen in six months.
- •Psychiatric history.
- •Pregnant woman or woman need to breast feed or woman with positive chorionic gonadotrophin (HCG).
- •Uncontrolled diabetes or hypertension.
- •Interstitial pneumonia or Active pulmonary fibrosis.
- •Acute bacterial or fungal infection.
- •Oral or intravenous use of steroids.
研究组 & 干预措施
high-dose TRT
high-dose thoracic radiotherapy X-ray RT
干预措施: high-dose TRT (Radiation)
standard-dose TRT
standard-dose thoracic radiotherapy XRT
干预措施: standard-dose TRT (Radiation)
结局指标
主要结局
overall survival
时间窗: 2 years
The time interval between diagnosis and death
次要结局
- Incidence of tumor recurrence in local or regional area(2 years)
- Incidence of radiotherapy and chemotherapy induced toxicities assessed by CTCAE v 4.0(2 years)
- progression-free survival(2 years)
研究者
Luhua Wang
Vice President of Cancer hospital of CAMS
Chinese Academy of Medical Sciences