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扶中消积疗法对IIIC期结直肠癌辅助治疗后的应用价值探索
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注册号:

Registration number:

ChiCTR1900022755 

最近更新日期:

Date of Last Refreshed on:

2019-04-28 

注册时间:

Date of Registration:

2019-04-24 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

扶中消积疗法对IIIC期结直肠癌辅助治疗后的应用价值探索 

Public title:

The value of Fu-Zhong Xiao-Ji therapy after adjuvant treatment of colorectal cancer in stage IIIC 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

扶中消积疗法对IIIC期结直肠癌辅助治疗后的应用价值探索 

Scientific title:

The value of Fu-Zhong Xiao-Ji therapy after adjuvant treatment of colorectal cancer in stage IIIC 

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:

吴珺玮 

研究负责人:

郑岚 

Applicant:

Junwei Wu 

Study leader:

Lan zheng 

申请注册联系人电话:

Applicant telephone:

+86 18917038525 

研究负责人电话:

Study leader's telephone:

+86 13012880202 

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:

captaingem@126.com 

研究负责人电子邮件:

Study leader's E-mail:

windy9453@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:

上海市黄浦区瑞金二路197号 

研究负责人通讯地址:

上海市黄浦区瑞金二路197号 

Applicant address:

197 Second Ruijin Road, Huangpu District, Shanghai, China 

Study leader's address:

197 Second Ruijin Road, Huangpu District, Shanghai, 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:

上海交通大学医学院附属瑞金医院 

Applicant's institution:

Ruijin Hospital, Shanghai JiaoTong University, School of 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:

(2018)临伦审第(222)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:

上海交通大学医学院附属瑞金医院伦理委员会 

Name of the ethic committee:

Ruijin Hospital Ethics Committee,Shanghai Jiao Tong University,School of Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-12-29 

伦理委员会联系人:

王译锋 

Contact Name of the ethic committee:

Yifeng Wang 

伦理委员会联系地址:

上海市黄浦区瑞金二路197号 

Contact Address of the ethic committee:

197 Second Ruijin Road, Huangpu District, Shanghai, China 

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:

上海交通大学医学院附属瑞金医院 

Primary sponsor:

Ruijin Hospital, Shanghai JiaoTong University, School of Medicine 

研究实施负责(组长)单位地址:

上海市黄浦区瑞金二路197号 

Primary sponsor's address:

197 Second Ruijin Road, Huangpu 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):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海交通大学医学院附属瑞金医院

具体地址:

黄浦区瑞金二路197号

Institution
hospital:

Ruijin Hospital, Shanghai JiaoTong University, School of Medicine

Address:

197 Second Ruijin Road, Huangpu District

经费或物资来源:

上海市中西医临床协作试点项目建设 

Source(s) of funding:

Shanghai Traditional Chinese Medicine and Western Medicine Clinical Collaborative Pilot Project Construction 

研究疾病:

结直肠癌 

Target disease:

colorectal 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:

探索性研究/预试验 

Study phase:

研究目的:

探索“扶中消积疗法”在IIIC期结直肠癌患者辅助治疗后的有效性和安全性。并对每位患者辨证分型,探索中医各证型与本项目研究目标间的相关性,明确各证型及中药干预治疗对于患者治疗以及预后判断的指导意义。 

Objectives of Study:

To explore the efficacy and safety of Fuzhong Xiaoji Therapy in the adjuvant treatment of patients with stage IIIC colorectal cancer. According to the syndrome differentiation of each patient, explore the correlation between the syndrome types of TCM and the research objectives of this project, and clarify the guiding significance of each syndrome type and TCM intervention treatment for patient treatment and prognosis judgment. 

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、入组患者在进入初筛后,均需签署知情同意书; 2、受试者年龄≥18周岁且≤75周岁; 3、经组织学或细胞学病理确诊为“结直肠”腺癌;根据第7版AJCC分期标准,分期为IIIC期的结直肠癌患者; 4、经腹腔镜或开腹手术R0切除患者,并至少完成6周期CAPOX方案或8周期FOLFOX6方案辅助化疗,随机按2:1分组进入临床研究。分组时距最后一次化疗结束后2月内,且随机时评估未发现复发转移者; 5、直肠癌患者允许接受围手术期放射治疗(术前放化疗、术后放化疗或单纯化疗); 6、受试者一般状况较好,ECOG评分0-2分,预计生存期大于6个月;(ECOG参见附件1) 7、血清谷丙转氨酶(ALT)和谷草转氨酶(AST)≤2.5倍正常值上限,胆红素≤1.5倍正常值上限,肌酐≤1.5倍正常值上限;无严重其他并发疾病,如心功能不全等不适宜参加临床研究的患者。 8、育龄期妇女需要进行有效的避孕措施(男女均适用)。 

Inclusion criteria

1. Patients who enter the group must sign an informed consent form after entering the initial screening; 2. Aged from 18 years old to 75 years old; 3. Histological pathology confirmed as "colorectal" adenocarcinoma; according to the 8th edition of the AJCC staging criteria, stage IIIC colorectal cancer patients; 4. Laparoscopic or open surgery R0 resection patients, and at least 6 cycles of CAPOX program or 8 cycles of FOLFOX6 regimen adjuvant chemotherapy, randomized into 2:1 group into clinical studies. The grouping time was within 2 months after the end of the last chemotherapy, and no recurrence and metastasis was found at enrollment time. 5. Patients with rectal cancer are allowed to receive perioperative radiation therapy (preoperative radiotherapy and chemotherapy, postoperative radiotherapy or chemotherapy or chemotherapy alone); 6. The general condition of the subjects is good, the ECOG score is 0-2, and the expected survival time is more than 6 months; 7. serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal, bilirubin ≤ 1.5 times the upper limit of normal, creatinine ≤ 1.5 times the upper limit of normal; no serious other complications, such as cardiac insufficiency Patients who are not suitable for clinical research; 8. Women of childbearing age need effective contraceptive measures (both male and female) 

排除标准:

1. 怀孕或哺乳期妇女,没有运用避孕手段的育龄期妇女; 2. 辅助治疗完成后中药治疗入组前影像评估出现疾病转移或复发; 3. 受试者存在症状明显的心脏疾病(心律失常、心功能不全或心肌梗塞病史); 4. 受试者存在活动性感染、活动性出血或严重的代谢障碍; 5. 受试者存在其他恶性肿瘤病史(除非已经治愈达5年以上); 6. 正在接受其他临床药物试验或者前次临床药物试验结束未满3个治疗周期; 7. 研究者判断其他不适合参加本项目的受试者。 

Exclusion criteria:

1. Pregnant or lactating women, women of childbearing age who do not use contraception; 2. After the completion of adjuvant therapy, the Chinese medicine treatment was evaluated to have disease metastasis or recurrence before enrollment; 3. The subject has a symptomatic heart disease (arrhythmia, cardiac insufficiency or history of myocardial infarction); 4. The subject has active infection, active bleeding or severe metabolic disorders; 5. The subject has a history of other malignancies (unless he has been cured for more than 5 years); 6. Undertake of other interventional clinical trials or the end of the previous clinical trials less than 3 treatment cycles; 7. The investigator determines other subjects who are not eligible to participate in the program. 

研究实施时间:

Study execute time:

From2019-05-01To 2022-05-01 

干预措施:

Interventions:

组别:

试验组

样本量:

100

Group:

experimental group

Sample size:

干预措施:

扶中消积法

干预措施代码:

Intervention:

fuzhong xiaoji therapy

Intervention code:

组别:

对照组

样本量:

50

Group:

Control group

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

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):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海交通大学医学院附属瑞金医院 

单位级别:

三甲 

Institution
hospital:

Ruijin Hospital, Shanghai JiaoTong University, School of Medicine  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

无疾病生存率/时间

指标类型:

主要指标 

Outcome:

disease free survival

Type:

Primary indicator 

测量时间点:

1年

测量方法:

Measure time point of outcome:

1 year

Measure method:

ratio

指标中文名:

无疾病生存率/时间

指标类型:

主要指标 

Outcome:

Disease free survival

Type:

Primary indicator 

测量时间点:

2年

测量方法:

Measure time point of outcome:

2 year

Measure method:

ratio

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:

正在进行

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):

非随机

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

non-random

盲法:

N/A

Blinding:

N/A

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):

www.chictr.org.cn

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

www.chictr.org.cn

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:

eCRF,ResMan

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

eCRF,ResMan

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-04-24
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