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Sparing the salivary glands to decrease the risk of xerostomia by intensity modulated radiotherapy in the treatment of head and neck cancer: a prospective clinical study
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注册号:

Registration number:

ChiCTR-ONN-17010597 

最近更新日期:

Date of Last Refreshed on:

2017-02-09 

注册时间:

Date of Registration:

2017-02-09 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

头颈部恶性肿瘤调强放疗保护唾液腺减轻口干症的前瞻性临床研究  

Public title:

Sparing the salivary glands to decrease the risk of xerostomia by intensity modulated radiotherapy in the treatment of head and neck cancer: a prospective clinical study  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

头颈部恶性肿瘤调强放疗保护唾液腺减轻口干症的前瞻性临床研究 

Scientific title:

Sparing the salivary glands to decrease the risk of xerostomia by intensity modulated radiotherapy in the treatment of head and neck cancer: a prospective clinical study 

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

滕峰 

研究负责人:

马林 

Applicant:

Teng Feng 

Study leader:

Ma Lin 

申请注册联系人电话:

Applicant telephone:

+86 18901268105 

研究负责人电话:

Study leader's telephone:

+86 13911197589 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

tfeng0611@126.com 

研究负责人电子邮件:

Study leader's E-mail:

malinpharm@sina.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

北京市朝阳区酒仙桥一街坊6号清华大学第一附属医院肿瘤科 

研究负责人通讯地址:

北京市海淀区复兴路28号 中国人民解放军总医院放疗科 

Applicant address:

6 Jiuxianqiao Area, Chaoyang District, Beijing, China 

Study leader's address:

28 Fuxing Road, Haidian District, Beijing  

申请注册联系人邮政编码:

Applicant postcode:

100016 

研究负责人邮政编码:

Study leader's postcode:

100853 

申请人所在单位:

清华大学第一附属医院 

Applicant's institution:

First Affiliated Hospital of Tsinghua Uinversity 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

S2016-122-01 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

中国人民解放军总医院医学伦理委员会 

Name of the ethic committee:

The Ethic Committee of The General Hospital of People’s Liberation Army  

伦理委员会批准日期:

Date of approved by ethic committee:

2016-11-24 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

中国人民解放军总医院 

Primary sponsor:

The General Hospital of People’s Liberation Army 

研究实施负责(组长)单位地址:

北京市海淀区复兴路28号 中国人民解放军总医院放疗科 

Primary sponsor's address:

28 Fuxing Road, Haidian District, Beijing 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京市

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

中国人民解放军总医院

具体地址:

北京市海淀区复兴路28号 中国人民解放军总医院放疗科

Institution
hospital:

The General Hospital of People’s Liberation Army

Address:

28 Fuxing Road, Haidian District, Beijing

经费或物资来源:

自筹经费 

Source(s) of funding:

self-financing 

研究疾病:

头颈部恶性肿瘤 

Target disease:

head and neck cancer 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

头颈部恶性肿瘤总体发病率占全身肿瘤的5%~10%,在全球恶性肿瘤中发病率第6位,死亡率第8位,主要发生在包括唇、口腔、咽喉、鼻腔副鼻窦、唾液腺等部位。放射治疗是头颈部恶性肿瘤治疗的主要方法之一。但唾液腺体功能减退导致口干是放射治疗最常见的晚期不良反应,严重影响患者生活质量,比如咀嚼、吞咽、讲话、睡眠障碍,还会继发口腔感染、放射性龋齿等其他疾病。因此为了减轻患者口干症状、改善生活质量,在头颈部恶性肿瘤放射治疗中进行唾液腺体保护显得至关重要。如何最大限度降低患者口干症状,是当前临床研究需要解决的重要问题。随着科学技术的发展,放射治疗依次经历了二维普放、三维适形(3D-CRT)、调强放射治疗(IMRT)、图像引导(IGRT)、自适应放疗(DGRT-ART)。新的技术和设备的出现为我们开展此项临床奠定了一定物质基础。我科在最近临床试验中初步研究表明:通过调强放射治疗全面限制唾液腺体(腮腺、颌下腺、舌下腺以及小涎腺)体积和剂量可以明显减轻患者口干症状,改善患者生活质量。但是目前样本量比较小且属于回顾性研究,进行腺体危及器官靶区保护属于不同放疗医生勾画,没有统一标准,因此没有大样本前瞻性临床试验证明:头颈部恶性肿瘤放射治疗中全面保护腺体能够明显降低口干症状且不会增加局部区域肿瘤的复发和淋巴结转移。因此,我们研究团队拟开展这方面的前瞻性临床试验研究:通过调强放射治疗保护腮腺、颌下腺以及舌下腺、口腔涎腺限制其受照体积和剂量;通过对患者唾液流速的客观测量和患者口干症状调查表的主观评价来判断通过全面保护腺体后患者口干症状的改善情况,从而指导以后临床实际工作,给患者带来益处。为了进一步减轻口干进行自适应调强放疗(DGRT-ART)再计划的必要性研究奠定一定理论和临床基础,可进一步探索自适应放疗中(DGRT-ART)再计划因患者体重减轻、肿瘤体积缩小可以进一步最大限度保护腺体减少口干症状的疗效开辟道路。 

Objectives of Study:

The overall incidence of head and neck cancer accounts for 5 % ~ 10 % of the total tumors, the sixth in global malignancy, the eighth in the mortality rate , mainly in the lips, mouth, throat, nasal cavity, sinuses, salivary glands. Radiotherapy is one of the main methods for the treatment of head and neck cancer. However, the subside of salivary glands lead to xerostomiais the most common late adverse reaction, seriously affecting the quality of life, such as chewing, swallowing, speech, sleep disorders, and oral infection, radiation caries. Therefore, in order to alleviate the xerostomia and improve the quality of life, salivary gland protection is very important in radiotherapy of head and neck malignant tumors. How to minimize the dry mouth symptoms of patients is an important issue in clinical research. With the development of science and technology, radiotherapy has undergone erweipufang, three-dimensional conformal ( 3d CRT ), intensity modulated radiotherapy ( IMRT ), image guidance ( IGRT), adaptive radiotherapy ( DGRT-ART). The emergence of new technology and equipment has laid a solid foundation for us to carry out this clinical practice. The preliminary study of our department in recent clinical trials shows that the overall limited salivary gland ( parotid, submandibular gland, sublingual gland and minor salivary gland ) by intensity modulated radiotherapy can significantly reduce the xerostomia and improve the quality of life of patients. However, at present, the sample size is small and belongs to retrospective study, the gland lesions target area protection belongs to different radiotherapy doctors without unified standard, so there is no large sample prospective clinical trial. Therefore, our research team will intend to carry out prospective clinical trials on the protection of parotid, submandibular and sublingual gland, oral salivary gland to limit their volume and dose; Through the objective measurement of saliva flow rate and subjective evaluation of the patient xerostomia questionnaire to determine the improvement of xerostomia after comprehensive protection of the glands, so as to guide the clinical practical work, to bring benefits. In order to further reduce the necessity of adaptive intensity modulated radiotherapy ( DGRT-ART), a theoretical and clinical basis, can further explore adaptive radiotherapy (DGRT-ART ), because of weight loss, tumor size reduction can further maximize the protection of glands to reduce the effect of xerostomia . 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

1、原发肿瘤为头颈部恶性肿瘤,包括口腔、咽喉、鼻腔副鼻窦、唾液腺等部位; 2、影像学检查(MRI平扫+增强,无法行MR检查时采用CT平扫+增强;颈部浅表淋巴结彩超)明确原发病变侵及范围及淋巴结转移情况; 3、有明确的病理学诊断及临床分期; 4、预期生存大于2年; 5、允许颈部及锁骨上区淋巴结转移; 6、无远处器官转移; 7、允许诱导化疗、同步化疗、巩固化疗、靶向药物治疗等治疗方式参与; 8、未进行手术干预治疗; 9、功能状态评分(KPS)评分≥70分,体能状态评分(ECOG ):0-1分; 10、年龄18-65岁; 11、完整的病历资料(病史、体检、相关检查、既往治疗); 12、可行唾液流速测定及定期口干评估量表评分; 13、自愿参加并书面签署知情同意书。 

Inclusion criteria

1. the primary tumor is head and neck malignant tumor, including the parts of the mouth, throat, nasal cavity, sinuses, salivary gland; 2. the imaging examination ( MRI ) was enhanced, and the CT enhancement was used in Mr examination. The neck superficial linbajiecai ( super ) confirmed the scope and lymph node metastasis of primary disease; 3. definite pathological diagnosis and clinical stage; 4. life expectancy is more than 2 years; 5. cervical and supraclavicular lymph node metastasis is allowed; 6. no organ transfer; 7. allow induction chemotherapy, synchronous chemotherapy, consolidation of chemotherapy, targeted drug therapy and other treatment modalities; 8. no operation intervention was carried out; 9. the functional state score ( KPS ) score ≥ 70, the physical status score ( ECOG ): 0-1socre; 10. Aged 18-65 years old; 11. complete medical records ( history, physical examination, related examination, treatment); 12. the feasible saliva flow rate and the table score of the regular dry mouth; 13. voluntary participation and written and signed informed consent. 

排除标准:

1、既往干燥综合征等其他风湿免疫系统疾病; 2、唾液腺体行手术或其他物理治疗; 3、既往头颈部手术外伤史; 4、既往有头颈部放疗史; 5、拒绝或者不能签署书面知情同意书; 

Exclusion criteria:

1. other rheumatic immune system diseases such as Sjogren's syndrome; 2. salivary gland cyst operation or other physical therapy; 3. history of head and neck surgery trauma; 4. head and neckradiationthearpy; 5. refusal or unable to sign the written informed consent. 

研究实施时间:

Study execute time:

From2017-03-01To 2019-03-31 

征募观察对象时间:

Recruiting time:

From2017-03-01To 2017-03-31 

干预措施:

Interventions:

组别:

A

样本量:

40

Group:

A

Sample size:

干预措施:

保护腮腺+口腔

干预措施代码:

Intervention:

Protection of parotid gland and oral cavity

Intervention code:

组别:

B

样本量:

40

Group:

B

Sample size:

干预措施:

保护颌下腺+口腔

干预措施代码:

Intervention:

Protection of Submandibular gland and oral cavity

Intervention code:

组别:

C

样本量:

40

Group:

C

Sample size:

干预措施:

仅保护口腔

干预措施代码:

Intervention:

Protect oral cavity only

Intervention code:

组别:

D

样本量:

40

Group:

D

Sample size:

干预措施:

保护腮腺+颌下腺+口腔

干预措施代码:

Intervention:

Protect both parotid gland, submandibular gland, and oral cavity

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京市 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国人民解放军总医院 

单位级别:

三级甲等医院 

Institution
hospital:

The General Hospital of People’s Liberation Army  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

唾液流速

指标类型:

主要指标 

Outcome:

Velocity of saliva

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

口干评分

指标类型:

主要指标 

Outcome:

xerostomia score

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

口干评分

指标类型:

主要指标 

Outcome:

xerostomia score

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

总生存期

指标类型:

主要指标 

Outcome:

OS

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

无进展生存期

指标类型:

主要指标 

Outcome:

DFS

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

唾液

组织:

Sample Name:

saliva

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 65 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

非随机实效性研究,根据临床患者实际治疗情况来决定分组

Randomization Procedure (please state who generates the random number sequence and by what method):

no random effectiveness study, based on actual clinical treatment of patients to determine the group

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

Yes

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

2019年7月31日,论文形式

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

2019-7-31published paper

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

试验数据将汇入病例报告表库,输入计算机保存 HIS系统

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Test data will be imported into CRFs, then input computer.,HIS (hospital information system)

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2017-02-09
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