SBRT Compared With IMRT Concurrently With Chemotherapy in Treating Patients With LS-SCLC
2016年4月10日 更新者:Xueqin Yang、Third Military Medical University
Stereotactic Body Radiation Therapy Compared With Intensity Modulated Radiation Therapy Concurrently With Chemotherapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
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
研究概览
研究类型
介入性
注册 (预期的)
50
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Chongqing
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Chongqing、Chongqing、中国、400042
- 招聘中
- Daping Hospital, Third Military Medical University
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接触:
- Xueqin Yang, PH.D.
- 电话号码:86-23-68757151
- 邮箱:yangxueqin@hotmail.com
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首席研究员:
- Xueqin Yang, PH.D.
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:GROUP 1
SBRT plus EP
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40 Gy for each patient.
Patients receiving once-daily therapy ,4 Gy daily in 10 treatments over a period of two weeks.
Etoposide 75mg/m2/iv over 90min through day 1 to day 4 and cisplatin 25mg/m2/iv over 30min through day 1 to day 3, repeat Q 3weeks.
Continuous administration to six cycles or to disease progression, unacceptable toxicity or patients' refusal.
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有源比较器:GROUP 2
IMRT plus EP
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Etoposide 75mg/m2/iv over 90min through day 1 to day 4 and cisplatin 25mg/m2/iv over 30min through day 1 to day 3, repeat Q 3weeks.
Continuous administration to six cycles or to disease progression, unacceptable toxicity or patients' refusal.
45 Gy for each patient,Accelerated twice-daily thoracic radiotherapy involved the administration of 1.5 Gy in 30 treatments over a period of three weeks.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
progression-free survival
大体时间: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
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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
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
肿瘤缓解率
大体时间:反应者人数与可评估肿瘤反应的患者人数之间的比率,评估长达1年
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反应者人数与可评估肿瘤反应的患者人数之间的比率,评估长达1年
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Overall survival
大体时间:From date of randomization until last survival confirm date or date of death from any cause, whichever came first, assessed up to 3 years
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From date of randomization until last survival confirm date or date of death from any cause, whichever came first, assessed up to 3 years
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Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
大体时间:the first date of treatment to 3 months after the last dose of study drug
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Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
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the first date of treatment to 3 months after the last dose of study drug
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Xueqin Yang, PHD、Daping Hospital, Third Military Medical University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Turrisi AT 3rd, Kim K, Blum R, Sause WT, Livingston RB, Komaki R, Wagner H, Aisner S, Johnson DH. Twice-daily compared with once-daily thoracic radiotherapy in limited small-cell lung cancer treated concurrently with cisplatin and etoposide. N Engl J Med. 1999 Jan 28;340(4):265-71. doi: 10.1056/NEJM199901283400403.
- Li C, Xiong Y, Zhou Z, Peng Y, Huang H, Xu M, Kang H, Peng B, Wang D, Yang X. Stereotactic body radiotherapy with concurrent chemotherapy extends survival of patients with limited stage small cell lung cancer: a single-center prospective phase II study. Med Oncol. 2014 Dec;31(12):369. doi: 10.1007/s12032-014-0369-x. Epub 2014 Nov 22.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2016年1月1日
初级完成 (预期的)
2019年1月1日
研究完成 (预期的)
2020年1月1日
研究注册日期
首次提交
2016年3月25日
首先提交符合 QC 标准的
2016年4月10日
首次发布 (估计)
2016年4月14日
研究记录更新
最后更新发布 (估计)
2016年4月14日
上次提交的符合 QC 标准的更新
2016年4月10日
最后验证
2016年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
SBRT的临床试验
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Soonchunhyang University HospitalSMG-SNU Boramae Medical Center尚未招聘肿瘤 | 继发性恶性肿瘤
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Kantonsspital Winterthur KSWKrebsforschung Schweiz, Bern, Switzerland招聘中