Phase III Randomized Study of Hypofractionated vs Conventionally Fractionated Concurrent Chemo-radiotherapy for Limited Disease Small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 860
- 试验地点
- 2
- 主要终点
- overall survival
研究概览
简要总结
The purpose of this study is to determine whether hypofractionated concurrent chemo-radiotherapy has the same efficiency as conventionally fractionated concurrent chemo-radiotherapy in Limited Disease Small Cell Lung Cancer.
详细描述
For patients with Limited Disease Small Cell Lung Cancer, 45Gy/15F of radiotherapy with concurrent chemotherapy will be used in experimental arm. While 60Gy/30F of radiotherapy with concurrent chemotherapy 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 0-2
- •patients with histologically or cytologically proved small cell lung cancer
- •Limited disease (LD), was characterized by tumors confined to one hemithorax. It may include ipsilateral hilar, both mediastinum and both supraclavicular nodes. Metastatic lymph nodes were defined as lymph nodes with short diameter of more than 1cm or FDG uptake in PET. The thickness of pleural effusion was less than 1cm unless malignant pleural effusion was cytologically proved. In a word, stage I-IIIB excluding the patients with lung metastases should be defined as LD according to AJCC cancer staging 7th edition.
- •No progression after 2 cycles of chemotherapy with EP.
- •No prior history of anti-tumor treatment.
- •No severe internal diseases and no organ dysfunction
- •Written informed consent provided and
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
conventionally fractionated CRT
conventionally fractionated concurrent chemoradiotherapy
干预措施: conventionally fractionated concurrent chemoradiotherapy (Radiation)
hypofractionated CRT
hypofractionated concurrent chemoradiotherapy
干预措施: hypofractionated concurrent chemoradiotherapy (Radiation)
结局指标
主要结局
overall survival
时间窗: 2 years
次要结局
- disease free survival(2 years)
- local-regional failure (Incidence of tumor recurrence in local or regional area)(2 years)
- toxicity (Incidence of radiotherapy and chemotherapy induced toxicities assessed by CTCAE v 4.0)(2 year)
研究者
LVHUA WANG
Vice President of Cancer hospital of CAMS
Cancer Institute and Hospital, Chinese Academy of Medical Sciences