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碘125粒子联合化疗治疗Ⅲ同期放化疗后局部复发临床研究
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注册号:

Registration number:

ChiCTR-IOR-15006560 

最近更新日期:

Date of Last Refreshed on:

2015-06-13 

注册时间:

Date of Registration:

2015-06-13 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

碘125粒子联合化疗治疗Ⅲ同期放化疗后局部复发临床研究 

Public title:

Combination of Iodine-125 brachytherapy and chemotherapy for locally recurrent stage III non-small cell lung cancer after concurrent chemoradiotherapy 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

碘125粒子联合化疗治疗Ⅲ同期放化疗后局部复发临床研究 

Scientific title:

Combination of Iodine-125 brachytherapy and chemotherapy for locally recurrent stage III non-small cell lung cancer after concurrent chemoradiotherapy 

研究课题代号(代码):

Study subject ID:

20050116 

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:

李进 

研究负责人:

何敬东 

Applicant:

Li Jin 

Study leader:

He Jingdong 

申请注册联系人电话:

Applicant telephone:

+86 15051389633 

研究负责人电话:

Study leader's telephone:

+86 13861596338 

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:

lijin83doctor@163.com 

研究负责人电子邮件:

Study leader's E-mail:

hjddoctor@126.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:

江苏省淮安市淮阴区北京西路6号 

研究负责人通讯地址:

江苏省淮安市淮阴区北京西路6号 

Applicant address:

6 West Beijing Road, Huaiyin district, Huaian, Jiangsu, China 

Study leader's address:

6 West Beijing Road, Huaiyin district, Huaian, Jiangsu, China 

申请注册联系人邮政编码:

Applicant postcode:

223300 

研究负责人邮政编码:

Study leader's postcode:

223300 

申请人所在单位:

淮安市第一人民医院(南京医科大学附属淮安第一医院) 

Applicant's institution:

The First People's Hospital, Huaian (the First Hospital of Huaian Affiniated Nanjing Medical 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:

20050116 

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:

淮安市第一人民医院伦理委员会 

Name of the ethic committee:

Ethical committee of the people's first hospital,huaian 

伦理委员会批准日期:

Date of approved by ethic committee:

2005-03-29 

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:

淮安市第一人民医院(南京医科大学附属淮安第一医院) 

Primary sponsor:

The First People's Hospital, Huaian (the First Hospital of Huaian Affiniated Nanjing Medical University) 

研究实施负责(组长)单位地址:

江苏省淮安市淮阴区北京西路6号 

Primary sponsor's address:

6 West Beijing Road, Huaiyin district, Huaian, Jiangsu, 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):

江苏

市(区县):

淮安

Country:

China

Province:

Jiangsu

City:

Huaian

单位(医院):

淮安市第一人民医院(南京医科大学附属淮安第一医院)

具体地址:

江苏省淮安市淮阴区北京西路6号

Institution
hospital:

The First People's Hospital, Huaian (the First Hospital of Huaian Affiniated Nanjing Medical University)

Address:

6 West Beijing Road, Huaiyin district, Huaian, Jiangsu, China

经费或物资来源:

淮安市第一人民医院 

Source(s) of funding:

The First People's Hospital, Huaian (the First Hospital of Huaian Affiniated Nanjing Medical University) 

研究疾病:

非小细胞肺癌 

Target disease:

non small lung cancer 

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:

其它 

Study phase:

N/A 

研究目的:

评价碘-125粒子植入联合化疗治疗同期放化疗后局部复发的III期非小细胞肺癌的疗效及其安全性 

Objectives of Study:

To explore the therapeutic effect of radioactive seed 125I implantation combined chemotherapy for local recurrent stage III non-small Cell Lung Cancer (NSCLC) patients after concurrent chemoradiotherapy regimen, and to assess the feasibility of 125I brachytherapy as a suitable therapy for patients with local recurrent stage III NSCLC after Concurrent Chemoradiotherapy. 

药物成份或治疗方案详述:

多西紫杉醇、顺铂 

Description for medicine or protocol of treatment in detail:

docetaxel 60mg/m2 ,cisplatin 75 mg/m2 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

⑴接受过同期放疗化疗后1年内局部复发的III期非小细胞肺癌患者;⑵预计生存期大于6个月;⑶肿瘤的直径≤6cm;⑷无严重的肝、肾功能不全、心脏病、糖尿病、凝血功能障碍等疾病;⑸无严重的肺部基础疾病;⑹患者的PS评分≤2分。⑺胸部CT片上病灶有穿刺路径;⑻患者及家属同意行放射性粒子植入治疗。 

Inclusion criteria

1. patients with locally recurrent stage III NSCLC within one year after receiving concurrent chemoradiotherapy; 2. time of survival was estimated to be longer than three months; 3. tumor diameter was less than 6 cm; 4. no severe liver insufficiency, renal insufficiency, heart diseases, diabetes, coagulation dysfunction, and other chronic diseases; 5. no severer chronic basic pulmonary diseases; 6. the Eastern Cooperative Oncology Group (ECOG) score 2; 7. tumor lesion had a suitable position for brachytherapy, which was confirmed by chest CT scanning; 8. patients and their families were intended to receive the treatments of this study; 9. patients didn't receive any radiotherapy and chemotherapy within 3 months of the study procedure. All patients were evaluated by the investigators of this study (including the oncologists, surgical specialists, and radiologists of Huai'an First People's Hospital Affiliated to Nanjing Medical University) and confirmed to be able to receive the second-line chemotherapy (doctaxel (60 mg/m2, at day 1) plus cisplatin (75 mg/m2, at day 2)) and CT-guided radioactive 125I seed implantation. 

排除标准:

PS>2分;预期生存小于3个月;严重的肺动脉高压;严重的肺疾病引起严重的呼吸窘迫;重度肝、肾功能不全;III级以上的心功能不全;凝血功能异常;严重糖尿病。 

Exclusion criteria:

PS>2 score ,survival time more than 3m. 

研究实施时间:

Study execute time:

From2006-01-01To 2009-01-01 

征募观察对象时间:

Recruiting time:

From2006-06-01To 2013-01-01 

干预措施:

Interventions:

组别:

研究组

样本量:

26

Group:

research group

Sample size:

干预措施:

I-125 +DP

干预措施代码:

Intervention:

received the combined therapy of 125I brachytherapy and DP chemotherapy,

Intervention code:

组别:

对照组

样本量:

26

Group:

control group

Sample size:

干预措施:

DP

干预措施代码:

Intervention:

DP chemotherapy

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江苏 

市(区县):

淮安 

Country:

China 

Province:

Jiangsu 

City:

Huaian 

单位(医院):

淮安市第一人民医院(南京医科大学附属淮安第一医院) 

单位级别:

三级甲等 

Institution
hospital:

the people's first hospital,huaian (the first hospital of huaian affiniated Nanjing medical university)  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

疾病无进展时间

指标类型:

主要指标 

Outcome:

progression-free survival

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

局部控制时间

指标类型:

主要指标 

Outcome:

the time of local regional control

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:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 22 years
最大 Max age 75 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):

数字随机法

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

random by figure

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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):

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

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:

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

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2015-06-13
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