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生酮饮食联合伊立替康促进局部复发或转移性Her-2阴性乳腺癌患者化疗敏感性及靶病灶缓解:随机、对照、临床试验方案
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注册号:

Registration number:

ChiCTR1900024597 

最近更新日期:

Date of Last Refreshed on:

2019-07-18 

注册时间:

Date of Registration:

2019-07-18 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

生酮饮食联合伊立替康促进局部复发或转移性Her-2阴性乳腺癌患者化疗敏感性及靶病灶缓解:随机、对照、临床试验方案 

Public title:

Ketogenic diet combined with irinotecan is available for promoting chemotherapy sensitivity and reducing target lesions in patients with locally recurrent or metastatic Her-2 negative breast cancer: a randomized controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

生酮饮食联合伊立替康促进局部复发或转移性Her-2阴性乳腺癌患者化疗敏感性及靶病灶缓解:随机、对照、临床试验方案 

Scientific title:

Ketogenic diet combined with irinotecan is available for promoting chemotherapy sensitivity and reducing target lesions in patients with locally recurrent or metastatic Her-2 negative breast cancer: a randomized controlled trial 

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:

王妍 

研究负责人:

孙涛 

Applicant:

Yan Wang 

Study leader:

Tao Sun 

申请注册联系人电话:

Applicant telephone:

+86 13840093058 

研究负责人电话:

Study leader's telephone:

+86 13940404526 

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:

wyseaky@sina.com 

研究负责人电子邮件:

Study leader's E-mail:

jianong@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:

辽宁省沈阳市大东区小河沿路44号 

研究负责人通讯地址:

辽宁省沈阳市大东区小河沿路44号 

Applicant address:

44 Xiaoheyan Road, Dadong District, Shenyang, Liaoning, China 

Study leader's address:

44 Xiaoheyan Road, Dadong District, Shenyang, Liaoning, China 

申请注册联系人邮政编码:

Applicant postcode:

110042 

研究负责人邮政编码:

Study leader's postcode:

110042 

申请人所在单位:

辽宁省肿瘤医院 

Applicant's institution:

Liaoning Cancer Hospital & Institute 

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:

20170234 

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:

辽宁省肿瘤医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Liaoning Cancer Hospital & Institute 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-03-01 

伦理委员会联系人:

朴浩哲 

Contact Name of the ethic committee:

Haozhe Piao 

伦理委员会联系地址:

辽宁省沈阳市大东区小河沿路44号 

Contact Address of the ethic committee:

44 Xiaoheyan Road, Dadong District, Shenyang, Liaoning, 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:

辽宁省肿瘤医院 

Primary sponsor:

Liaoning Cancer Hospital & Institute 

研究实施负责(组长)单位地址:

辽宁省沈阳市大东区小河沿路44号 

Primary sponsor's address:

44 Xiaoheyan Road, Dadong District, Shenyang, Liaoning, 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):

辽宁

市(区县):

沈阳

Country:

China

Province:

Liaoning

City:

Shenyang

单位(医院):

辽宁省肿瘤医院

具体地址:

辽宁省沈阳市大东区小河沿路44号

Institution
hospital:

Liaoning Cancer Hospital & Institute

Address:

44 Xiaoheyan Road, Dadong District, Shenyang, Liaoning, China

经费或物资来源:

无 

Source(s) of funding:

None 

研究疾病:

局部复发或转移性Her-2阴性乳腺癌 

Target disease:

locally recurrent or metastatic Her-2 negative breast 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:

试验拟观察生酮饮食联合伊立替康对中国东北地区局部复发或转移性Her-2阴性乳腺癌患者化疗敏感性及靶病灶缓解的影响。 

Objectives of Study:

This trial is designed to observe the clinical efficacy of ketogenic diet combined with irinotecan on chemotherapy sensitivity and target lesion remission in patients with locally recurrent or metastatic Her-2 negative breast cancer in Northeast China. 

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:

- 具有组织学或细胞学检测确认的Her-2阴性乳腺癌患者。Her-2判定标准按照2006年ASCO和CAP联合制定并发布的乳腺癌Her-2检测指南进行判定; - 年龄18-70岁,女性患者; - 体质量指数(BMI)≥24 kg/m2,或体脂率≥28%; - TOP1表达率≥10%; - 无法实施根治手术的局部复发或转移性乳腺癌的患者,接受过最少两种用于治疗局部复发或转移性疾病的化疗方案; - 预计总生存期≥3个月者; - 入组前2周内存在RECIST v1.1 标准定义的可测量病灶; - ECOG评分0-2分; - 自愿参与研究并签署了书面知情同意书的患者。 

Inclusion criteria

1. Female patients with histologically or cytologically confirmed locally recurrent or metastatic breast cancer. HER2 testing criteria are based on 2006 American Society of Clinical Oncology (ASCO)/American College of Pathologists (CAP)-approved HER2 testing guideline for breast cancer; 2. Aged 18–70 years; 3. Body mass index >=24 kg/m2, or body fat percentage >=28%; 4. TOP1 expression rate >=10%; 5. Patients with locally recurrent or metastatic breast cancer who are unable to receive a radical surgery and have been treated with at least two chemotherapy regimens 6. Estimated overall survival >=3 months; 7. Measurable lesions defined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 within 2 weeks before enrollment; 8. Eastern Cooperative Oncology Group (ECOG) performance status score 0–2; 9. Provision of informed consent. 

排除标准:

- 已知UGT1A1*6纯合突变和/或UGT1A1*28纯合突变的患者; - 随机分组前4周内接受过化疗、手术治疗(指治疗乳腺癌的大型手术等)或分子靶向治疗者,2周内接受激素治疗或放疗;随机分组前 4 周内参加过其他药物临床试验; - 未得到控制的高血压或不稳定型心绞痛。 - 已知患有中枢神经系统(CNS)疾病; - 不可控制的骨转移的患者; - 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; - 具有第二种原发性恶性肿瘤病史,不包括双侧乳腺癌、原位宫颈癌、经过充分治疗的皮肤非黑色素瘤癌及其他至少以往5年治疗过并且无复发证据的恶性肿瘤; - 哺乳期患者; - 进食困难者,不能配合生酮饮食治疗的患者。 

Exclusion criteria:

1. Patients with homozygous mutations in UGT1A1*6 and/or UGT1A1*28 (such patients are susceptible to irinotecan-induced diarrhea); 2. Patients who have received chemotherapy, surgery (such as a large surgery for breast cancer) or molecular targeted therapy within 4 weeks prior to randomization or who have received hormone therapy or radiotherapy within 2 weeks prior to randomization; 3. Patients who have participated other clinical trials within 4 weeks prior to randomization; 4. Uncontrolled hypertensionor unstable angina; 5. Patients who have developed central nervous system (CNS) diseased; 6. Uncontrollable bone metastasis; 7. Known or suspected allergy to the primary agent or any other drug administered during the study; 8. A history of another primary malignancies, except for bilateral breast cancer, in situ cervical carcinoma, fully treated non-melanoma skin cancer, and malignant tumors that have been treated and have not relapsed within 5 years. 9. Lactating women; 10. Patients who are unable to cooperate with ketogenic diet if they have trouble in eating. 

研究实施时间:

Study execute time:

From2019-12-02To 2022-12-31 

征募观察对象时间:

Recruiting time:

From2019-12-02To 2021-06-30 

干预措施:

Interventions:

组别:

联合干预组

样本量:

259

Group:

Experimental group

Sample size:

干预措施:

伊立替康单药+生酮饮食干预

干预措施代码:

Intervention:

irinotecan + ketogenic diet

Intervention code:

组别:

对照组

样本量:

259

Group:

Control group

Sample size:

干预措施:

伊立替康单药+普通饮食干预

干预措施代码:

Intervention:

irinotecan + normal diet

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

辽宁 

市(区县):

沈阳 

Country:

China 

Province:

Liaoning 

City:

Shenyang 

单位(医院):

辽宁省肿瘤医院 

单位级别:

三级甲等 

Institution
hospital:

Liaoning Cancer Hospital & Institute  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

肿瘤靶病灶客观缓解率

指标类型:

主要指标 

Outcome:

Objective remission rates (ORR)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

患者对化疗药物(伊立替康)的敏感性

指标类型:

主要指标 

Outcome:

Sensitivity to irinotecan

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

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:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

无进展生存期

指标类型:

次要指标 

Outcome:

progression-free survival

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

总生存时间

指标类型:

次要指标 

Outcome:

Overall survival

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

3和4级不良事件发生率

指标类型:

次要指标 

Outcome:

The incidences of grade 3-4 AEs

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血液生化检查指标

指标类型:

附加指标 

Outcome:

Blood biochemical index

Type:

Additional 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:

标本中文名:

血液

组织:

Sample Name:

Blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction 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 70 years

性别:

女性

Gender:

Female

随机方法(请说明由何人用什么方法产生随机序列):

试验采用随机数字表法分组。

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

Patients will be automatically assigned a random number generated.

盲法:

试验中结果指标收集者和评估者对试验不知晓。

Blinding:

Data collectors and evaluators will be blinded.

试验完成后的统计结果(上传文件):

点击下载

Calculated Results after
the Study Completed(upload file):

download

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):

出版数据将公开发布于www.figshare.com中

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

Anonymized trial data will be available indefinitely at www.figshare.com

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:

研究使用临床电子数据采集系统(EDC)进行数据收集与管理。

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

This study will use a password-protected electronic data collection system to manage the electronic CRFs.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-07-18
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