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中医综合规范化方案预防非小细胞肺癌根治术后复发转移的多中心随机对照研究
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注册号:

Registration number:

ChiCTR-IPR-16009062 

最近更新日期:

Date of Last Refreshed on:

2016-08-22 

注册时间:

Date of Registration:

2016-08-22 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

中医综合规范化方案预防非小细胞肺癌根治术后复发转移的多中心随机对照研究 

Public title:

Multi-center randomized controlled clinical trial of comprehensive treatment with Traditional Chinese Medicine and adjuvant chemotherapy on preventing the recurrence and metastasis of non-small cell lung cancer after radical operation 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

中医综合规范化方案预防非小细胞肺癌根治术后复发转移的多中心随机对照研究 

Scientific title:

Multi-center randomized controlled clinical trial of comprehensive treatment with Traditional Chinese Medicine and adjuvant chemotherapy on preventing the recurrence and metastasis of non-small cell lung cancer after radical operation 

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:

毕向雁 

研究负责人:

刘苓霜 

Applicant:

Xiangyan Bi 

Study leader:

Lingshuang Liu 

申请注册联系人电话:

Applicant telephone:

+86 18317067515 

研究负责人电话:

Study leader's telephone:

+86 13818510253 

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:

384901602@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

liuls107@163.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:

上海徐汇区宛平南路725号上海中医药大学附属龙华医院肿瘤科 

研究负责人通讯地址:

上海徐汇区宛平南路725号上海中医药大学附属龙华医院肿瘤科 

Applicant address:

Department of Oncology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, Xuhui District, Shanghai, China 

Study leader's address:

Department of Oncology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, Xuhui District, Shanghai, China 

申请注册联系人邮政编码:

Applicant postcode:

200032 

研究负责人邮政编码:

Study leader's postcode:

200032 

申请人所在单位:

上海中医药大学附属龙华医院 

Applicant's institution:

Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine 

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:

2016LCSY039 

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:

上海中医药大学附属龙华医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine. 

伦理委员会批准日期:

Date of approved by ethic committee:

2016-07-13 

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:

上海中医药大学附属龙华医院 

Primary sponsor:

Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

上海徐汇区宛平南路725号上海中医药大学附属龙华医院肿瘤科 

Primary sponsor's address:

Department of Oncology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, Xuhui District, Shanghai, 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):

上海

市(区县):

徐汇区

Country:

China

Province:

Shanghai

City:

Xuhui district

单位(医院):

上海中医药大学附属龙华医院

具体地址:

上海徐汇区宛平南路725号

Institution
hospital:

Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine.

Address:

725 South Wanping Road, Xuhui District, Shanghai, China

经费或物资来源:

上海市科学技术委员会 

Source(s) of funding:

Shanghai Science and Technology Committee 

研究疾病:

非小细胞肺癌 

Target disease:

Non-small cell 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:

上市后药物 

Study phase:

研究目的:

观察中医综合方案对预防非小细胞肺癌根治术后复发转移及改善生活质量的临床疗效,并对该方案的毒副反应和安全性做出评估。建立疗效确切、可供临床推广的规范化非小细胞肺癌根治术后中医综合治疗方案。 

Objectives of Study:

To observe the clinical effecacy of comprehensive treatment with Traditional Chinese Medicine and adjuvant chemotherapy on preventing the recurrence and metastasis, and improving the quality of life of patients with NSCLC after radical operation. To evaluate the toxicity and safety of the comprehensive treatment. Then, establishing comprehensive treatment which has definite curative effect and can be promoted for clinical practice in treating NSCLC after radical operation. 

药物成份或治疗方案详述:

1)中药颗粒剂 1.益气养阴、软坚解毒颗粒:生黄芪、北沙参、天冬、麦冬、夏枯草、石上柏、石见穿等; 2.益气、软坚解毒颗粒:生黄芪、白术、茯苓、仙灵脾、夏枯草、石上柏、石见穿等; 3.养阴、软坚解毒颗粒:南沙参、北沙参、天冬、麦冬、夏枯草、石上柏、石见穿等; 2)中药静脉制剂: 华蟾素注射液 

Description for medicine or protocol of treatment in detail:

1. Traditional Chinese medicine granules (1) Benifiting Qi and yin,resolving hard lump and detoxication granule: raw astragalus, radix glehniae, radix asparagi, Radix Ophiopogonis, Spica prunellae,Selaginella doederleinii,Salvia chinensia Benth,etc; (2) Benifiting Qi,resolving hard lump and detoxication granule: raw astragalus, Raw Rhizoma Atractylodis, Poria, Herba Epimedii, Spica prunellae, Selaginella doederleinii, Salvia chinensia Benth,etc; (3) Benifiting yi, resolving hard lump and detoxication granule: Radix Adenophorae, Radix Glehniae, Radix Asparagi, Radix Ophiopogonis, Spica prunellae, Selaginella doederleinii, Salvia chinensia Benth,etc; 2. Traditional Chinese medicine intravenous agents Cinobufacini injection 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

①Ib-Ⅲa期接受完全性手术切除患者,术后病理学证实为非小细胞肺癌; ②完全切除术后6周内尚未接受治疗的患者; ③中医辨证为气虚证、阴虚证或气阴两虚证; ④年龄在18岁-75岁之间(含18、75岁); ⑤体力状况评分(ECOG PS)≤2分; ⑥中性粒细胞绝对值>1.5×109/L、血小板计数>100×109/L、血红蛋白>100mg/dl,肝肾功能基本正常者; ⑦患者依从性好,能理解本研究的情况并签署知情同意书。 

Inclusion criteria

(1) patients with complete resection who are at TNM stage Ib-Ⅲa, postoperative pathology confirmed for non-small cell lung cancer; (2) patients who are within 6 weeks after complete resection have not been treated; (3) TCM syndrome differentiation is Qi deficiency syndrome, yin deficiency syndrome or Qi and Yin deficiency syndrome; (4) aged 18-75 years old (including 18, 75); (5) Eastern Cooperative OncologyGroup (ECOG) PS of two or less; (6) normal hematological function with total neutrophil count> 1.5 x 10^9/L, platelets count > 100 x 10^9/L , Lhemoglobin > 100 mg/dl and normal liver functionand kidney function; (7) patients compliance is good, and patients can understand the situation of this study and sign informed consent. 

排除标准:

①预期生存期<6个月者; ②无明确病理诊断者; ③患者合并有心、肝、肾和造血系统等严重疾病; ④妊娠或哺乳期患者; ⑤患有不易控制的精神病史者。 

Exclusion criteria:

(1) expected lifetime < 6 months; (2) there is no clear pathological diagnosis; (3) patients with intentional liver, kidney and hematopoietic diseases; (4) patients with pregnancy or lactation; (5) patients with hisory of serirous mental illness. 

研究实施时间:

Study execute time:

From2016-07-01To 2019-09-30 

干预措施:

Interventions:

组别:

试验组

样本量:

156

Group:

experimental group

Sample size:

干预措施:

中医综合方案治疗(辅助化疗+中药治疗)

干预措施代码:

Intervention:

Comprehensive treatment (adjuvant chemotherapy and treatment of TCM )

Intervention code:

组别:

对照组

样本量:

156

Group:

control group

Sample size:

干预措施:

辅助化疗+中药安慰剂治疗

干预措施代码:

Intervention:

Adjuvant chemotherapy and placebo

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

徐汇区 

Country:

China 

Province:

Shanghai 

City:

Xuhui distirct 

单位(医院):

上海中医药大学附属龙华医院 

单位级别:

三级甲等中医院 

Institution
hospital:

Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine.  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

杨浦区 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

同济大学附属上海市肺科医院 

单位级别:

三级甲等专科医院 

Institution
hospital:

Shanghai Pulmonary Hospital affiliated to Tongji University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

徐汇区 

Country:

China 

Province:

Shang hai 

City:

Xuhui district 

单位(医院):

上海市胸科医院 

单位级别:

三级甲等专科医院 

Institution
hospital:

Shanghai Chest Hospital  

Level of the institution:

Three level of specialized hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

卢湾区 

Country:

China 

Province:

Shanghai 

City:

Luwan district 

单位(医院):

上海交通大学医学院附属瑞金医院 

单位级别:

三级甲等综合性医院 

Institution
hospital:

Ruijin hospital affiliated to Medical School of Shanghai Jiaotong University  

Level of the institution:

Tertiary A hospital 

国家:

国家 

省(直辖市):

上海 

市(区县):

浦东新区 

Country:

China 

Province:

Shanghai 

City:

New pudong district 

单位(医院):

上海中医药大学附属曙光医院 

单位级别:

三级甲等中医院 

Institution
hospital:

Shuguang hospital affiliated to Shanghai University of Traditional Chinese Medicine.  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

2年无病生存率

指标类型:

主要指标 

Outcome:

2-year disease-free survival rate

Type:

Primary indicator 

测量时间点:

每2个化疗周期,每4个中医药治疗周期。随访期间两年内3个月随访一次,以后每6月随访一次。

测量方法:

观察是否有复发转移,是否生存

Measure time point of outcome:

Every two periods of chemotherapy, every four periods of TCM treatment. Every three months in two years, and then every six months during the follow-up period

Measure method:

Observe recurrence, metastasis, and survival condition

指标中文名:

无病生存期

指标类型:

主要指标 

Outcome:

Disease-free survival, DFS

Type:

Primary indicator 

测量时间点:

每2个化疗周期,每4个中医药治疗周期。随访期间两年内3个月随访一次,以后每6月随访一次。

测量方法:

观察是否有复发转移,是否生存

Measure time point of outcome:

Every two periods of chemotherapy, every four periods of TCM treatment. Every three months in two years, and then every six months during the follow-up period

Measure method:

Observe recurrence, metastasis, and survival condition

指标中文名:

生活质量

指标类型:

次要指标 

Outcome:

Quality of life

Type:

Secondary indicator 

测量时间点:

每个周期

测量方法:

EORTC QLQ-C30和QLQ-LC13生存质量量表

Measure time point of outcome:

Every period of treatment

Measure method:

the European Organizationfor Research and Treatment of Cancer quality-of-life question-naire QLQ-C30 (EORTC QLQ-C30, Chinese version 3.0) and EORTCQLQ-LC13 (Chinese version)

指标中文名:

体力状态评分

指标类型:

次要指标 

Outcome:

ECOG Performance Status

Type:

Secondary indicator 

测量时间点:

每个周期

测量方法:

ECOG PS评分标准

Measure time point of outcome:

Every period of treatment

Measure method:

ECOG PS scoring criteria

指标中文名:

中医症状量表

指标类型:

次要指标 

Outcome:

symptoms lists questionnaire of traditional Chinese medicine

Type:

Secondary indicator 

测量时间点:

每个周期

测量方法:

原发性肺癌症状分级量化表

Measure time point of outcome:

Every period of treatment

Measure method:

Primary lung cancer symptom classifying quantization tables

指标中文名:

总生存期

指标类型:

次要指标 

Outcome:

Overall survival

Type:

Secondary indicator 

测量时间点:

每2个化疗周期,每4个中医药治疗周期。随访期间两年内3个月随访一次,以后每6月随访一次。

测量方法:

是否生存

Measure time point of outcome:

Every two periods of chemotherapy, every four periods of TCM treatment. Every three months in two years, and then every six months during the follow-up period

Measure method:

Observe survival condition

指标中文名:

癌胚抗原

指标类型:

次要指标 

Outcome:

CEA(Carcino Embryonie Antigen)

Type:

Secondary indicator 

测量时间点:

每2个化疗周期,每4个中医药治疗周期

测量方法:

酶联免疫吸附法

Measure time point of outcome:

Every two periods of chemotherapy, every four periods of TCM treatment

Measure method:

Enzyme linked immunosorbent assay

指标中文名:

糖类抗原125

指标类型:

次要指标 

Outcome:

CA125 (Carbohydrate Antigen 125)

Type:

Secondary indicator 

测量时间点:

每2个化疗周期,每4个中医药治疗周期

测量方法:

酶联免疫吸附法

Measure time point of outcome:

Every two periods of chemotherapy, every four periods of TCM treatment

Measure method:

Enzyme linked immunosorbent assay

指标中文名:

细胞角蛋白19片段

指标类型:

次要指标 

Outcome:

CYFRA21-1(cytokeratin fragment antiogen 21-1)

Type:

Secondary indicator 

测量时间点:

每2个化疗周期,每4个中医药治疗周期

测量方法:

酶联免疫吸附法

Measure time point of outcome:

Every two periods of chemotherapy, every four periods of TCM treatment

Measure method:

Enzyme linked immunosorbent assay

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

blood

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 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):

随机过程及操作将由专业统计人员参与并主导完成,协助制定本临床试验方案中的统计设计,包括临床试验随机分配方案、协助数据管理等。

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

Random process and operation will be completed by professionals working in the department of statistics of Shanghai University of Traditional Chinese Medicine,and they will assist in the random assignment of clinical trials, data management and so on.

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):

研究结束并在论文发表后公开,通过上传Excel/word文件共享到中国临床试验注册中心

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

After completion of the trial and finishing the paper publication, the results will be shared through upload Excel or Word documents to the web of chinese clinical registry.

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:

原始数据记录由研究负责人保存,电子版采用excel及spss软件管理

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

All of the original data records are preserved by the head of this study, and the electronic version records are managed by excel and spss.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2016-08-22
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