Induction Chemotherapy in Young Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
2019年8月6日 更新者：Hai-Qiang Mai,MD,PhD、Sun Yat-sen University
Phase II Study of TPF Induction Chemotherapy Followed by Concurrent Chemoradiotherapy in Young Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
1. To see the effect if a combination of induction chemotherapy followed by chemoradiotherapy works in treating children with advanced nasopharyngeal carcinoma(NPC).
研究概览
详细说明
This phase II trial is studying how well radiation therapy and chemotherapy work in treating young patients with newly diagnosed nasopharyngeal cancer.
Radiation therapy uses high-energy x-rays to kill tumor cells.
Drugs used in chemotherapy, such as cisplatin and fluorouracil and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
研究类型
介入性
注册 (预期的)
37
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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Guangdong
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Guangzhou、Guangdong、中国、510060
- 招聘中
- Sun Yat-sen University
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接触：
- HaiQiang Mai, PhD
- 电话号码：8620-38606186
- 邮箱：maihq@sysucc.org.cn
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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
不超过 18年 (孩子、成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type).
- Original clinical staged as T4N0-3 M0 or any T、N3M0（according to the American Joint Committee on Cancer(AJCC) 7th edition）
- No evidence of distant metastasis (M0).
- Age ≤ 18 years old.
- Satisfactory performance status: Karnofsky scale (KPS) > 70.
- Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL.
- Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) <1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN.
- Adequate renal function: creatinine clearance ≥60 ml/min.
- Patients must be informed of the investigational nature of this study and give written informed consent.
Exclusion Criteria:
- WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
- Age >18 years.
- Treatment with palliative intent.
- Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
- Pregnancy or lactation.
- History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
- Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
- Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), and emotional disturbance.
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：不适用
- 介入模型：单组作业
- 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：Paclitaxel liposome, Cisplatin, 5-Fu,
Patients receive paclitaxel liposome(135mg/m2 on day 1), cisplatin (75mg/m2 on day 1,Separate injection on day 1 to 3) and fluorouracil (3750mg/m2 CIV 120h) every three weeks for three cycles before the radiotherapy, and then receive radical radiotherapy(Intensive modulate radiotherapy,IMRT)and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.
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Patients receive paclitaxel liposome(135mg/m2 on day 1),cisplatin (75mg/m2 Separate injection on day 1 to 3) and 5-fluorouracil (3750mg/m2 CIV 120h ) every three weeks for three cycl es before the radiotherapy. Patients receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy. Radical radiotherapy:Intensive modulate radiotherapy (IMRT),total dose for nasopharynx and nodule of neck:60Gy/30F,2.0Gy/daily.
其他名称：
Cisplatin (75mg/m2 Separate injection on day 1 to 3) with Paclitaxel liposome and 5-fu every three weeks for three cycles before the radiotherapy.Cisplatin(100mg/m2) every three weeks for three cycles during radiotherapy.
其他名称：
Fluorouracil (3750mg/m2 CIV 120h)with Paclitaxel liposomeand cisplatin every three weeks for three cycles before the radiotherapy.
其他名称：
Intensive modulate radiotherapy (IMRT) will be implement,total dose for nasopharynx and nodule of neck:60Gy(Gray)/30F(Fraction),2.0Gy/daily,5 days/week.
其他名称：
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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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Complete Response (CR)
大体时间：After the completion of the chemoradiotherapy treatment (up to 9 weeks)
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CR assessed by independent reviewers, according to the Modified Response Evaluation Criteria in Solid Tumors (RECIST) from the National Cancer Institute (NCI).
Disease response evaluated after the completion of the chemoradiotherapy treatment.
Complete response defined as the complete disappearance of the target and non-target lesion(s) identified at baseline after radiological evaluation by Magnetic Resonance Imaging (MRI) only
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After the completion of the chemoradiotherapy treatment (up to 9 weeks)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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由国家癌症研究所不良事件通用术语标准（4.0 版）评估的短期毒性作用
大体时间：3个月
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短期毒性作用由国家癌症研究所不良事件通用术语标准（4.0 版）评估
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3个月
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长期毒性
大体时间：通过学习完成，平均半年
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使用欧洲癌症研究和治疗组织生活质量调查问卷 C30 (EORTCQLQ-C30) 评估 QoL
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通过学习完成，平均半年
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长期毒性
大体时间：通过学习完成，平均半年
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EORTC 生活质量问卷(QLQ) 头颈
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通过学习完成，平均半年
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生长
大体时间：通过学习完成，平均半年
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将监测患者的身高（以米为单位）
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通过学习完成，平均半年
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生长
大体时间：通过学习完成，平均半年
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将监测患者的体重（公斤）
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通过学习完成，平均半年
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生长
大体时间：通过学习完成，平均半年
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将监测患者的 BMI（以 kg/m^2 为单位）
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通过学习完成，平均半年
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智力开发
大体时间：通过学习完成，平均半年
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Stanford-Binet 测试的智商
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通过学习完成，平均半年
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Overall survival(OS)
大体时间：3-year
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The OS was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.
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3-year
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Progress-free survival(PFS)
大体时间：3-year
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Progress-free survival is calculated from the date of randomization to the date of the first progress at any site or death from any cause or censored at the date of the last follow-up
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3-year
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Locoregional failure-free survival(LRFS)
大体时间：3-year
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The LRFS is evaluated and calculated from the date of random assignment until the day of first locoregional relapse or until the date of the last follow-up visit
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3-year
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Distant metastasis-free survival(DMFS)
大体时间：3-year
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The DMFS is evaluated and calculated from the date of random assignment until the day of first distant metastases or until the date of the last follow-up visit
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3-year
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Sex Development
大体时间：Through study completion, an average of half year
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Sex hormone(estrogen,testosterone) levels(in nmol/L)
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Through study completion, an average of half year
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Sex Development
大体时间：Through study completion, an average of half year
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Secondary sex characteristic survey
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Through study completion, an average of half year
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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：HaiQiang Mai, MD,PhD、Cancer center
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
- Daoud J, Ghorbal L, Siala W, Elloumi F, Ghorbel A, Frikha M. [Is there any difference in therapeutic results of nasopharyngeal carcinoma between adults and children?]. Cancer Radiother. 2013 Dec;17(8):763-7. doi: 10.1016/j.canrad.2013.06.046. Epub 2013 Nov 20. French.
- Yan Z, Xia L, Huang Y, Chen P, Jiang L, Zhang B. Nasopharyngeal carcinoma in children and adolescents in an endemic area: a report of 185 cases. Int J Pediatr Otorhinolaryngol. 2013 Sep;77(9):1454-60. doi: 10.1016/j.ijporl.2013.06.005. Epub 2013 Jul 3.
- Liao WW, Tang SQ, Liu Y, Feng C. [Treatment of nasopharyngeal carcinoma in children]. Zhongguo Dang Dai Er Ke Za Zhi. 2013 Apr;15(4):273-6. Chinese.
- Hu S, Xu X, Xu J, Xu Q, Liu S. Prognostic factors and long-term outcomes of nasopharyngeal carcinoma in children and adolescents. Pediatr Blood Cancer. 2013 Jul;60(7):1122-7. doi: 10.1002/pbc.24458. Epub 2013 Jan 9.
- Cheuk DK, Billups CA, Martin MG, Roland CR, Ribeiro RC, Krasin MJ, Rodriguez-Galindo C. Prognostic factors and long-term outcomes of childhood nasopharyngeal carcinoma. Cancer. 2011 Jan 1;117(1):197-206. doi: 10.1002/cncr.25376. Epub 2010 Aug 24.
- Buehrlen M, Zwaan CM, Granzen B, Lassay L, Deutz P, Vorwerk P, Staatz G, Gademann G, Christiansen H, Oldenburger F, Tamm M, Mertens R. Multimodal treatment, including interferon beta, of nasopharyngeal carcinoma in children and young adults: preliminary results from the prospective, multicenter study NPC-2003-GPOH/DCOG. Cancer. 2012 Oct 1;118(19):4892-900. doi: 10.1002/cncr.27395. Epub 2012 Feb 22.
- Shen C, Gao Y, Xu T, Wang X, Ying H, Hu C. Carcinoma of the nasopharynx in young patients: a single institution experience. Clin Oncol (R Coll Radiol). 2009 Oct;21(8):617-22. doi: 10.1016/j.clon.2009.07.005. Epub 2009 Aug 5.
- Varan A, Ozyar E, Corapcioglu F, Koksal Y, Aydin B, Yazici N, Akyuz C, Buyukpamukcu M. Pediatric and young adult nasopharyngeal carcinoma patients treated with preradiation Cisplatin and docetaxel chemotherapy. Int J Radiat Oncol Biol Phys. 2009 Mar 15;73(4):1116-20. doi: 10.1016/j.ijrobp.2008.05.028. Epub 2008 Sep 9.
- Laskar S, Bahl G, Muckaden M, Pai SK, Gupta T, Banavali S, Arora B, Sharma D, Kurkure PA, Ramadwar M, Viswanathan S, Rangarajan V, Qureshi S, Deshpande DD, Shrivastava SK, Dinshaw KA. Nasopharyngeal carcinoma in children: comparison of conventional and intensity-modulated radiotherapy. Int J Radiat Oncol Biol Phys. 2008 Nov 1;72(3):728-36. doi: 10.1016/j.ijrobp.2008.01.032. Epub 2008 Apr 18.
- Selek U, Ozyar E, Ozyigit G, Varan A, Buyukpamukcu M, Atahan IL. Treatment results of 59 young patients with nasopharyngeal carcinoma. Int J Pediatr Otorhinolaryngol. 2005 Feb;69(2):201-7. doi: 10.1016/j.ijporl.2004.09.001.
- Orbach D, Brisse H, Helfre S, Klijanienko J, Bours D, Mosseri V, Rodriguez J. Radiation and chemotherapy combination for nasopharyngeal carcinoma in children: Radiotherapy dose adaptation after chemotherapy response to minimize late effects. Pediatr Blood Cancer. 2008 Apr;50(4):849-53. doi: 10.1002/pbc.21372.
- Ahern V, Jenkin D, Banerjee D, Greenberg M, Payne D. Nasopharyngeal carcinoma in the young. Clin Oncol (R Coll Radiol). 1994;6(1):24-30. doi: 10.1016/s0936-6555(05)80364-4.
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 (实际的)
2016年11月14日
初级完成 (预期的)
2020年12月30日
研究完成 (预期的)
2022年12月30日
研究注册日期
首次提交
2016年12月14日
首先提交符合 QC 标准的
2017年1月11日
首次发布 (估计)
2017年1月13日
研究记录更新
最后更新发布 (实际的)
2019年8月7日
上次提交的符合 QC 标准的更新
2019年8月6日
最后验证
2019年8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.
Paclitaxel liposome的临床试验
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