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Randomized phase II/III trial of stereotactic body radiotherapy versus conventional multi-fractional radiotherapy for spine metastases.
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注册号:

Registration number:

ChiCTR-TRC-14004281 

最近更新日期:

Date of Last Refreshed on:

2016-08-13 

注册时间:

Date of Registration:

2014-02-21 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

立体定向放疗对比常规低分割放疗治疗脊柱转移瘤骨痛的前瞻性随机对照研究 

Public title:

Randomized phase II/III trial of stereotactic body radiotherapy versus conventional multi-fractional radiotherapy for spine metastases. 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

立体定向放疗对比常规低分割放疗治疗脊柱转移瘤骨痛的前瞻性随机对照研究 

Scientific title:

Randomized phase II/III trial of stereotactic body radiotherapy versus conventional multi-fractional radiotherapy for spine 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:

庄婷婷 

研究负责人:

庄婷婷 

Applicant:

Zhuang Tingting 

Study leader:

Zhuang Tingting 

申请注册联系人电话:

Applicant telephone:

+86 18902746030 

研究负责人电话:

Study leader's telephone:

+86 18902746030 

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:

ttz303@21cn.com 

研究负责人电子邮件:

Study leader's E-mail:

ttz303@21cn.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:

广东省汕头市饶平路7号 

研究负责人通讯地址:

广东省汕头市饶平路7号 

Applicant address:

7 Raoping Road, Shantou, Guangdong, China 

Study leader's address:

7 Raoping Road, Shantou, Guangdong, China 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

广东省汕头市汕头大学医学院附属肿瘤医院 

Applicant's institution:

Cancer Hospital of Shantou University Medical College 

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:

2014020803 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

汕头大学医学院附属肿瘤医院 

Name of the ethic committee:

Cancer Hospital of Shantou University Medical College 

伦理委员会批准日期:

Date of approved by ethic committee:

2014-02-10 

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:

汕头大学医学院附属肿瘤医院 

Primary sponsor:

Cancer Hospital of Shantou University Medical College 

研究实施负责(组长)单位地址:

广东省汕头市饶平路7号 

Primary sponsor's address:

7 Raoping Road, Shantou, 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

市(区县):

汕头

Country:

China

Province:

Guangdong

City:

Shantou

单位(医院):

汕头大学医学院附属肿瘤医院

具体地址:

广东省汕头市饶平路7号

Institution
hospital:

Cancer Hospital of Shantou University Medical College

Address:

7 Raoping Road, Shantou, Guangdong, China

经费或物资来源:

汕头大学医学院和汕头大学医学院附属肿瘤医院 

Source(s) of funding:

Shantou University Medical College and Cancer Hospital of Shantou University Medical College 

研究疾病:

脊柱转移瘤 

Target disease:

spinal metastasis 

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:

I期临床试验 

Study phase:

研究目的:

验证立体定向放疗(SBRT)治疗脊柱转移瘤患者的疗效和安全性,并比较SBRT 24Gy/2F与EBRT前后对穿30Gy/10F的两种放疗方法在疗效与毒性等方面的差别。 

Objectives of Study:

The first object is to confirm the efficacy and safety of stereotactic body radiotherapy(SBRT) in treatment of spine metastases.The second object is to compare the treatment effect and toxicity between SBRT (24Gy in 2 fractions) and conventional multi-fractional radiotherapy (30Gy in 10 fractions). 

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 

Study design:

Parallel 

纳入标准:

年龄≥18岁; 有病理确诊原发肿瘤,有病理或影像学提示脊柱转移; 可以长时间平躺; 一般状况可(KPS≥40); 脊柱转移灶≤3个; 预期寿命超过半年(改良的Tokuhashi预后评分法得分≥9分); 没有脊柱不稳定或骨折; 拟照射部位未曾接受过放射治疗或核素治疗; WBC ≥2.5×109/L, PLT≥70.0×109/L, Hb ≥70g/L; 签署知情同意书。 

Inclusion criteria

Aged 18 years and more; Histologically proven primary malignancy; Histologically or imaging shown spinal metastasis; Be able to lie flat for an extended period of time; Karnofsky performance status score≥40; The number of spinal metastases ≤3; Life expectancy more than half a year(revised Tokuhashi score≥9); No mechanically unstable spine or fracture; No previous radiotherapy or radionuclide therapy to the metastatic spinal segment; WBC≥2.5×10^9/L, PLT≥70.0×10^9/L,Hb ≥70g/L; Patient consensus. 

排除标准:

椎管受侵狭窄超过25%的; 脊柱移位或脊髓和受压硬膜间距离小于3mm的; 脊柱不稳定可能导致或已经出现压缩性骨折的; 因各种原因不能做脊柱增强MRI检查的; 有结缔组织病史的; 妊娠期妇女。 

Exclusion criteria:

The spine canal constriction 25% or more; Spine displacement; Epidural compression approaching spinal cord within 3mm; Spine instability may due to a compression fracture; Unsustainable to MRI for any reason; History of connective tissue disease; Pregnant women. 

研究实施时间:

Study execute time:

From2014-03-01To 2017-03-01 

征募观察对象时间:

Recruiting time:

From2014-03-01To 2017-03-01 

干预措施:

Interventions:

组别:

对照组

样本量:

50

Group:

control group

Sample size:

干预措施:

常规放疗

干预措施代码:

Intervention:

conventional multi-fractional radiotherapy

Intervention code:

组别:

研究组

样本量:

50

Group:

research group

Sample size:

干预措施:

立体定向放疗

干预措施代码:

Intervention:

stereotactic body radiotherapy

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

汕头大学医学院附属肿瘤医院 

单位级别:

三级 

Institution
hospital:

Cancer Hospital of Shantou University Medical College  

Level of the institution:

Tertiary hospital 

国家:

中国 

省(直辖市):

广东 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

汕头市中心医院 

单位级别:

三级甲等 

Institution
hospital:

Shantou Central Hospintal  

Level of the institution:

Tertiary-A hospital 

测量指标:

Outcomes:

指标中文名:

毒副反应

指标类型:

副作用指标 

Outcome:

toxicities

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

一般状况评分

指标类型:

附加指标 

Outcome:

KPS score

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疼痛评分

指标类型:

主要指标 

Outcome:

Pain 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:

24小时内口服吗啡等效用量

指标类型:

主要指标 

Outcome:

OME

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

骨转移灶大小变化

指标类型:

次要指标 

Outcome:

metastasis tumor size

Type:

Secondary 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:

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 90 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):

随机数字表

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

random number table

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

No

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):

Not stated

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

Not stated

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:

Not stated

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

Not stated

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:

 2014-02-21
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