NCT02738723Unknown2 期
Stereotactic Body Radiation Therapy Compared With Intensity Modulated Radiation Therapy Concurrently With Chemotherapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- progression-free survival
研究概览
简要总结
As stereotactic radiotherapy (SBRT) has been widely used in clinical practice at present, the aim of this study is to evaluate the efficacy and safety of stereotactic body radiation therapy compared with intensity modulated radiation therapy (IMRT) concurrently with EP regimen(cisplatin plus etoposide) in treating patients with limited-stage small cell 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologic or cytologic diagnosis of SCLC
- •limited-stage disease is defined as disease confined to the ipsilateral hemithorax, which can be safely encompassed within a radiation field
- •No prior chemotherapy, or radiotherapy
- •Performance status of 0, 1, 2 on the ECOG criteria.
- •At least one unidimensional measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST. 2000).
- •Adequate hematologic (neutrophil count >= 1,500/uL, platelets >= 100,000/uL), hepatic (transaminase =< upper normal limit(UNL)x2.5, bilirubin level =< UNLx1.5), and renal (creatinine =< UNL) function
- •If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine device [IUD], birth control pills, or barrier device) during and for 3 months after trial. If male, use of an approved contraceptive method during the study and 3 months afterwards. Females with childbearing potential must have a urine negative HCG test within 7 days prior to the study enrollment.
排除标准
- •Non small cell lung cancer and carcinoid
- •Supraclavicular lymphadenopathy
- •Inability to comply with protocol or study procedures.
- •Moderate and severe ventilation dysfunction
- •Medically uncontrolled serious heart, lung, neurological, psychological, metabolic disease
- •Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
- •Pregnant or breast-feeding.
- •Enrollment in other study within 30 days
研究组 & 干预措施
GROUP 1
Experimental
SBRT plus EP
干预措施: SBRT (Radiation)
GROUP 1
Experimental
SBRT plus EP
干预措施: EP (Drug)
GROUP 2
Active Comparator
IMRT plus EP
干预措施: IMRT (Radiation)
GROUP 2
Active Comparator
IMRT plus EP
干预措施: EP (Drug)
结局指标
主要结局
progression-free survival
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first，assessed up to 3 years
次要结局
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](the first date of treatment to 3 months after the last dose of study drug)
- Overall survival(From date of randomization until last survival confirm date or date of death from any cause, whichever came first, assessed up to 3 years)
- Tumor response rate(the ratio between the number of responders and number of patients assessable for tumor response，assessed up to 1 years)
研究者
Xueqin Yang
Prof.
Third Military Medical University
研究点 (1)
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