The Role of Concurrent Chemotherapy for Lower Risk Locally Advanced Nasopharyngeal Carcinoma(NPC) in the Era of IMRT
2021年1月28日 更新者：Jun-Lin Yi, MD、Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Multicenter Phase III Study of Intensity-modulated Radiotherapy Alone Compared to Intensity-modulated Radiotherapy Combined Chemotherapy for Lower Risk Locally Advanced Nasopharyngeal Carcinoma
The purpose of this study is to verify that simultaneous integrated boost IMRT (SIB-IMRT) alone is non-inferior to SIB-IMRT combined with concurrent chemotherapy for low-risk locally advanced nasopharyngeal carcinoma.
研究概览
详细说明
- There were several randomized clinical trials confirmed that concurrent chemoradiotherapy (CCRT) is superior to radiotherapy (RT)alone for locally advanced NPC, most of the patients in the trials were treated with conventional radiotherapy technique.
- As the new technique of IMRT used more and more in the clinical practice, the role of concurrent chemoradiotherapy (CCRT) seems blurred, in two of Hongkong phaseIII studies(NPC9901/9902), half of the patients were treated by 3-dimensional conformal radiotherapy (3DCRT)/IMRT,the results showed that there were no significant different in terms of overall survival between RT alone and CCRT groups. Furthermore, several large sample size retrospective studies from China, showed that there were no advantage of CCRT over RT alone when treated by SIB-IMRT.
- In an analysis of who will benefit from CCRT,( Lin, et.al, IJROBP,2004; 60:156-164), the author divided the locally advanced NPC patients into two groups, with the high-risk group defined as patients met at least one of following criteria: nodal size >6 cm, (2) supraclavicular node metastasesN3, T4N2 and multiple neck node metastases with 1 node >4cm.
- Based on these information, we hypothesize that, for low-risk locally advanced NPC patients, there may no need CCRT under SIB-IMRT treatment.
研究类型
介入性
注册 (预期的)
590
阶段
- 第三阶段
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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Beijing、中国、100021
- 招聘中
- Cancer Hospital, Chinese Academy of Medical Sciences
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接触：
- Junlin YI, MD
- 电话号码：861087788504
- 邮箱：yijunlin1969@163.com
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Guangdong
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Guangzhou、Guangdong、中国、510060
- 尚未招聘
- Department of nasopharyngeal carcinoma, Cancer hospital, Sun Yat-Sen University
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接触：
- Xiang Guo, MD
- 电话号码：8613902251681
- 邮箱：guoxiang@sysucc.org.cn
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Guangzhou、Guangdong、中国、510060
- 招聘中
- Department of Radiation oncology, Cancer hospital, Sun Yat-Sen University
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接触：
- Chong Zhao, MD
- 电话号码：8613902206160
- 邮箱：zhaochong@sysucc.org.cn
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Hubei
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Wuhan、Hubei、中国、430030
- 尚未招聘
- Zhongnan Hospital of Wuhan University
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接触：
- Conghua Xie, MD
- 电话号码：8613638607566
- 邮箱：chxie_65@hotmail.com
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Wuhan、Hubei、中国、430032
- 招聘中
- Tongji hospital, Huazhong University of Science & Technology
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接触：
- Guoqing Hu, MD
- 电话号码：8613707189803
- 邮箱：gqhu@tjh.tjmu.edu.cn
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Jiangxi
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Nanchang、Jiangxi、中国、330029
- 尚未招聘
- Jiangxi Province Cancer Hospital
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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:
- Histopathological proven non-keratin nasopharyngeal carcinoma
- AJCC 7th edition stage III/IVM0, without any one of following factors: node size >6cm;supraclavicular metastasis node; T4N2; multiple neck node metastases with 1 node >4 cm
- Life expectancy≥6 months
- Adequate renal function, defined as follows: Serum creatinine < 2 x institutional upper limit of normal(ULN) within 2 weeks prior to registration or creatinine clearance rate (CCr) ≥ 50 ml/min within 2 weeks prior to registration determined by 24- hour collection or estimated by Cockcroft-Gault formula: CCr male = [(140 - age) x (wt in kg)] [(Serum Cr mg/dl) x (72)] CCr female = 0.85 x (CCrmale)
- The following assessments are required within 2 weeks prior to the start of registration: Na, K, Cl, glucose, Ca, Mg, and albumin
Exclusion Criteria:
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; noninvasive cancers (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible) are permitted even if diagnosed and treated < 3 years ago
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- Severe, active co-morbidity
- Treatment planning does not meet the requirement of prescription dose.
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：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：RT alone
SIB-IMRT was given to the patients with a regimen of 69.96Gy-73.92Gy
to the gross target volume, 60Gy to the high risk clinical target volume, 50Gy to the low risk clinical target volume
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SIB-IMRT was given to the patients with regimen of 69.96Gy-73.92Gy
to the gross target volume, 60Gy to the high risk clinical target volume, 50Gy to the low risk clinical target volume
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|
有源比较器：CCRT group
SIB-IMRT was given to the patients with regimen of 69.96Gy-73.92Gy
to the gross target volume, 60Gy to the high risk clinical target volume, 50Gy to the low risk clinical target volume and cisplatin 100mg/m2 was given at d1, d22,d43 during radiotherapy.
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SIB-IMRT was given to the patients with regimen of 69.96Gy-73.92Gy
to the gross target volume, 60Gy to the high risk clinical target volume, 50Gy to the low risk clinical target volume
Cisplatin 100mg/m2 was delivered at d1,d22 and d43 to the CCRT group patients during radiotherapy.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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overall survival
大体时间：5 years
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according to the recruitment, a interrim analysis will done in July, 2019, if there is inferior finding of RT alone group, the study will premature terminate
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5 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Acute and late toxicities
大体时间：5years
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5years
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3 year Progression-free survival (PFS)
大体时间：5year
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to compare the 3years PFS between the IMRT alone and IMRT with concurrent chemoradiotherapy
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5year
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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：Li Gao, MD、Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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
2013年4月1日
初级完成 (实际的)
2019年7月30日
研究完成 (预期的)
2021年3月30日
研究注册日期
首次提交
2013年3月20日
首先提交符合 QC 标准的
2013年3月20日
首次发布 (估计)
2013年3月22日
研究记录更新
最后更新发布 (实际的)
2021年1月29日
上次提交的符合 QC 标准的更新
2021年1月28日
最后验证
2020年7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.
SIB-IMRT的临床试验
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IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity of Bologna; Catholic University of the Sacred Heart; Howard University完全的前列腺癌
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IRCCS Azienda Ospedaliero-Universitaria di Bologna未知
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Cancer Institute and Hospital, Chinese Academy...完全的