今天是:2018-04-21 星期六

脊柱转移瘤术中放疗疗效及安全性的临床研究
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注册号:

Registration number:

ChiCTR1800014439 

最近更新日期:

Date of Last Refreshed on:

2018-04-16 

注册时间:

Date of Registration:

1990-01-01 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

脊柱转移瘤术中放疗疗效及安全性的临床研究 

Public title:

Clinical study on the efficacy and safety of intraoperative radiotherapy in the spinal metastases 

注册题目简写:

IORT 

English Acronym:

IORT 

研究课题的正式科学名称:

脊柱转移瘤术中放疗疗效及安全性的临床研究 

Scientific title:

Clinical study on the efficacy and safety of intraoperative radiotherapy in the spinal metastases 

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:

陈铿 

研究负责人:

陈铿 

Applicant:

Keng Chen 

Study leader:

Keng Chen 

申请注册联系人电话:

Applicant telephone:

+86 13602425774 

研究负责人电话:

Study leader's telephone:

+86 13602425774 

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:

chen.keng@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

chen.keng@qq.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:

广东省广州市沿江西路107号孙逸仙纪念医院 

研究负责人通讯地址:

广东省广州市沿江西路107号孙逸仙纪念医院 

Applicant address:

107 Yanjiang Road West, Guangzhou, Guangdong, China 

Study leader's address:

107 Yanjiang Road West, Guangzhou, Guangdong, China 

申请注册联系人邮政编码:

Applicant postcode:

510000 

研究负责人邮政编码:

Study leader's postcode:

510000 

申请人所在单位:

中山大学孙逸仙纪念医院 

Applicant's institution:

Sun-Yat-Sen Memorial Hospital, Sun-Yat-Sen University 

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:

[2018]快审第(40)号 

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:

中山大学孙逸仙纪念医院医学伦理委员会 

Name of the ethic committee:

Ethics committee of Sun-Yat-Sen Memorial Hospital, Sun-Yat-Sen University 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-03-15 

伦理委员会联系人:

林双秀 

Contact Name of the ethic committee:

Shuangxiu Lin 

伦理委员会联系地址:

广东省广州市沿江西路107号 

Contact Address of the ethic committee:

107 Yanjiang Road West, Guangzhou, Guangdong, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 020-81332587 

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:

中山大学孙逸仙纪念医院 

Primary sponsor:

Sun-Yat-Sen Memorial Hospital, Sun-Yat-Sen University 

研究实施负责(组长)单位地址:

广东省广州市沿江西路107号 

Primary sponsor's address:

107 Yanjiang Road West, Guangzhou, Guangdong, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

广东省

市(区县):

广州市

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

孙逸仙纪念医院

具体地址:

广东省广州市沿江西路107号

Institution
hospital:

Sun-Yat-Sen Memorial Hospital

Address:

107 Yanjiang Road West, Guangzhou, Guangdong, China

经费或物资来源:

逸仙临床研究培育项目 

Source(s) of funding:

Sun-Yat-Sen Clinical Research Cultivating Program 

研究疾病:

脊柱转移瘤 

Target disease:

spinal metastases 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional 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:

本课题拟开展前瞻性随机对照临床研究,采用脊柱转移瘤术中放疗,研究其安全性和有效性,有助于为脊柱转移瘤治疗提供有效的证据。 

Objectives of Study:

Prospective randomized controlled clinical study of the cninical safty and eddectiveness of intraoperative radiotherapy for spinal metastases. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照试验 

Study design:

Randomized parallel controlled trial 

纳入标准:

1) 18岁以上成人; 2) 有恶性肿瘤病史和/或影像学/病理学诊断为脊柱转移瘤; 3) 累及脊柱的转移瘤; 4) 预期生存时间≥3个月; 5) VAS疼痛评分≥3、或合并病理性骨折、神经功能损伤的椎体转移瘤。 

Inclusion criteria

1) over 18 years old; 2) the history of malignant tumor and / or imaging / pathology were diagnosed as spinal metastases; 3) metastatic tumor involved the vertebral; 4) expected survival time more than 3 months; 5) VAS pain score ≥3, or pathological fracture of vertebral body, neurologic injury and metastases. 

排除标准:

1) 不能耐受麻醉和俯卧体位; 2) 凝血障碍患者; 3) 随访MRI/CT检查禁忌患者; 4) 孕期/哺乳期妇女; 5) 无法进行知情同意的精神疾病; 6) 伴发其他会导致生存期缩短、慢性疼痛的严重疾病; 7) 恶液质,器官功能失代偿; 8) 滥用药物以及医学、心理学或社会条件可能干扰患者参与研究或对研究结果的评估有影响; 9) 已知或怀疑对研究药物过敏或对给予的与本试验相关的任何药物过敏; 10) 任何不稳定的状况或可能危及患者安全性以及依从性的情况. 

Exclusion criteria:

1) intolerance of anesthesia and prone position; 2) patients with coagulation disorders; 3) patients who were unable to perform MRI/CT examination; 4) pregnant / lactation women; 5) mental illness that cannot be informed of informed consent; 6) other serious diseases that may lead to shorter survival and chronic pain; 7) dyscrasia, organ function decompensation; 8) drug abuse and medical, psychological or social conditions may interfere with the patient's participation in the study or the assessment of the results of the study; 9) any allergy to the study of drug allergy or any drug allergy to this test is known or suspected; 10) any unstable state or condition that may jeopardize the safety and compliance of the patient. 

研究实施时间:

Study execute time:

From2018-01-13To 2020-03-31 

干预措施:

Interventions:

组别:

IORT组

样本量:

85

Group:

IORT group

Sample size:

干预措施:

手术+术中放疗

干预措施代码:

Intervention:

Surgery + IORT

Intervention code:

组别:

OP组

样本量:

85

Group:

OP group

Sample size:

干预措施:

仅进行手术

干预措施代码:

Intervention:

Surgery only

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东省 

市(区县):

广州市 

Country:

China 

Province:

Guangdong 

City:

Guangzhou City 

单位(医院):

孙逸仙纪念医院 

单位级别:

三甲 

Institution
hospital:

Sun-Yat-Sen Memorial Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

局部控制率

指标类型:

主要指标 

Outcome:

Local control rate

Type:

Primary indicator 

测量时间点:

1年

测量方法:

MR,CT

Measure time point of outcome:

1 year

Measure method:

MR,CT

指标中文名:

疼痛

指标类型:

主要指标 

Outcome:

Pain

Type:

Primary indicator 

测量时间点:

0,3,6,12,18,24,30,36个月

测量方法:

VAS评分

Measure time point of outcome:

0, 3, 6, 12, 18, 24, 30, 36 months

Measure method:

VAS score

指标中文名:

脊柱稳定性

指标类型:

次要指标 

Outcome:

Spinal stability

Type:

Secondary indicator 

测量时间点:

0,6,12,18,24,30,36个月

测量方法:

MR,CT/X片

Measure time point of outcome:

0, 3, 6, 12, 18, 24, 30, 36 months

Measure method:

MR, CT/Xray

指标中文名:

脊髓神经功能

指标类型:

次要指标 

Outcome:

Neurologic function

Type:

Secondary indicator 

测量时间点:

0,3,6,12,18,24,30,36个月

测量方法:

脊髓损伤功能评价

Measure time point of outcome:

0, 3, 6, 12, 18, 24, 30, 36 months

Measure method:

ASIA

指标中文名:

活动能力

指标类型:

次要指标 

Outcome:

Activity ability

Type:

Secondary indicator 

测量时间点:

0,3,6,12,18,24,30,36个月

测量方法:

临床评估

Measure time point of outcome:

0, 3, 6, 12, 18, 24, 30, 36 months

Measure method:

clinical evaluation

指标中文名:

手术并发症

指标类型:

次要指标 

Outcome:

Surgery complication

Type:

Secondary indicator 

测量时间点:

0,3,6,12个月

测量方法:

临床评估

Measure time point of outcome:

0, 3, 6, 12months

Measure method:

clinical evaluation

指标中文名:

放疗并发症

指标类型:

次要指标 

Outcome:

Radiation complication

Type:

Secondary indicator 

测量时间点:

0,3,6,12,18,24,30,36个月

测量方法:

临床评估

Measure time point of outcome:

0, 3, 6, 12, 18, 24, 30, 36 months

Measure method:

clinical evaluation

指标中文名:

生存期

指标类型:

次要指标 

Outcome:

Life period

Type:

Secondary indicator 

测量时间点:

最后一次随访

测量方法:

临床评估

Measure time point of outcome:

Last follow-up

Measure method:

clinical evaluation

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

椎体病灶

组织:

肿瘤

Sample Name:

spinal tumor sample

Tissue:

tumor

人体标本去向

使用后销毁 

说明

病理确诊与分型

Fate of sample:

Destruction after use 

Note:

Pathological diagnosis

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 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):

随机分组:仅接受有资格的研究者进行的患者随机化。 本研究采用分段随机,随机分配编码由统计学专业人员在计算机上模拟产生,给定种子数(seed),采用SAS统计软件产生随机数字表,随机信息采用不可见信封进行隐匿封存。研究者把病人信息汇报给随机人员,随机人员按入组先后顺序拆信开不可见信封,将随机信息给该研究者,完成随机。

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

Random grouping: patient randomization only accepted by qualified researchers. In this study, a piecewise random allocation code is generated by computer professionals. The number of given seeds is generated by using SAS statistical software to generate random numbers. The researchers put the patient information reporting

盲法:

Blinding:

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

研究结束后,如果需要,数据将会公开

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

After the study finishes, the data will be public when required

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:

数据表由研究负责单位保管

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

Research form should be saved by the responsible units

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 1990-01-01
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