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帕洛诺司琼联合地塞米松加或不加奥氮平防治三日顺铂方案化疗诱发的恶心呕吐的疗效比较:多中心、随机、平行组、对照研究
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注册号:

Registration number:

ChiCTR-IPR-14005265 

最近更新日期:

Date of Last Refreshed on:

2014-10-12 

注册时间:

Date of Registration:

2014-08-11 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

帕洛诺司琼联合地塞米松加或不加奥氮平防治三日顺铂方案化疗诱发的恶心呕吐的疗效比较:多中心、随机、平行组、对照研究 

Public title:

Comparison of the effects of Palonosetron and Dexamethasone with and without Olanzapine to prevent the nausea and vomiting induced by 3-day cisplatin based chemotherapy in cancer patients: a multi cen 

注册题目简写:

CINV 

English Acronym:

CINV 

研究课题的正式科学名称:

帕洛诺司琼联合地塞米松加或不加奥氮平防治三日顺铂方案化疗诱发的恶心呕吐的疗效比较:多中心、随机、平行组、对照研究 

Scientific title:

Comparison of the effects of Palonosetron and Dexamethasone with and without Olanzapine to prevent t 

研究课题代号(代码):

Study subject ID:

PDO-3dCINV 

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:

王士勇 

研究负责人:

王士勇 

Applicant:

Shiyong Wang 

Study leader:

Shiyong Wang 

申请注册联系人电话:

Applicant telephone:

+86 024-62043335 

研究负责人电话:

Study leader's telephone:

+86 024-62043335 

申请注册联系人传真 :

Applicant Fax:

+86 024-62571119 

研究负责人传真:

Study leader's fax:

+86 024-62571119 

申请注册联系人电子邮件:

Applicant E-mail:

cmu4h_swzlk@126.com 

研究负责人电子邮件:

Study leader's E-mail:

cmu4h_swzlk@126.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

http://www.cmu4h.cn/ 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

http://www.cmu4h.cn/ 

申请注册联系人通讯地址:

沈阳市皇姑区崇山东路4号 

研究负责人通讯地址:

沈阳市皇姑区崇山东路4号 

Applicant address:

No.4 East Chongshan Road, Huanggu District, Shenyang, CHINA 

Study leader's address:

No.4 East Chongshan Road, Huanggu District, Shenyang, CHINA 

申请注册联系人邮政编码:

Applicant postcode:

110032 

研究负责人邮政编码:

Study leader's postcode:

110032 

申请人所在单位:

中国医科大学附属第四医院 

Applicant's institution:

the Fourth Affiliated Hospital of China Medical Un 

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:

ChiECRCT-20140032 

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:

中国注册临床试验伦理审查委员会 

Name of the ethic committee:

China Ethics Committee of Registering Clinical Trials 

伦理委员会批准日期:

Date of approved by ethic committee:

2014-09-09 

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:

中国医科大学附属第四医院 

Primary sponsor:

the Fourth Affiliated Hospital of China Medical University 

研究实施负责(组长)单位地址:

沈阳市皇姑区崇山东路4号 

Primary sponsor's address:

No.4 East Chongshan Road, Huanggu District, Shenyang, 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):

Country:

China

Province:

Liaoning

City:

单位(医院):

中国医科大学附属第四医院

具体地址:

沈阳市皇姑区崇山东路4号

Institution
hospital:

the Fourth Affiliated Hospital of China Medical Un

Address:

No.4 East Chongshan Road, Huanggu District, Shenya

经费或物资来源:

自筹 

Source(s) of funding:

self - provided 

研究疾病:

恶性肿瘤 

Target disease:

malignant neoplasm 

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:

III期临床试验 

Study phase:

研究目的:

明确帕洛诺司琼和地塞米松加或不加奥氮平,对顺铂三日化疗诱发的延迟性恶性、呕吐的效果及安全性,找到适合防治顺铂三日化疗的止吐方案。 

Objectives of Study:

To define the effects and safety of Palonosetron and Dexamethasone with and without Olanzapine to prevent the delayed nausea and vomiting induced by 3-day cisplatin based chemotherapy in cancer patients, so as to identify a suitable antiemetic regimen for prevention of nausea and vomiting induced by 3-day cisplatin based chemotherapy. 

药物成份或治疗方案详述:

奥氮平;帕洛诺司琼;地塞米松 

Description for medicine or protocol of treatment in detail:

Olanzapine,Palonosetron,Dexamethasone 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1、拟接受化疗的初治或复治的肺癌、胃癌等患者,有明确的病理学诊断,拟接受含顺铂的3日化疗; 2、年龄 ≥18岁,预计生存时间3个月以上; 3、ECOG ≤ 2分; 4、足够的骨髓储备功能:血常规白细胞>4000/μl,中性粒细胞≥ 2000/μl, HB ≥ 10 g/L, Pt ≥ 80000/μl; 5、肾、肝功能:基本正常; 6、心脏功能:基本正常心脏功能,预计能完成化疗(既往没有心律失常、不可控的充血性心功能衰竭及6个月内的急性心肌梗死); 7、化疗前24小时内无恶心、呕吐; 8、没有认知障碍; 9、既往没有中枢神经疾病史,如不可控的脑转移、癫痫; 10、没有精神病 (也不属于以下情况:使用抗精神病药物的如氯氮平、利培酮、喹硫平、吩噻嗪或butyrophen 已经使用30天,或者需要在研究期间继续使用;长期使用吩噻嗪等抗精神类药物。但是,如果氯吡嗪或其他的吩噻嗪药物作为解救性治疗是可以的)。 11、 非腹部的同步放化疗; 12、没有不可控的糖尿病史; 13、依存性好,所有患者能书写知情同意书,同意参加本临床的实验. 

Inclusion criteria

1. Patients with lung cancer or gastric cancer et al; with defined pathological diagnosis; will accept initial treatment or retreatment with 3-day cisplatin based chemotherapy; 2. Age over 18 years old, and predicted life expectancy longer than 3 months; 3. ECOG less than 2; 4. With sufficient bone marrow reserve function: white cell count more than 4000/ul, neutrophile granulocyte count more than 2000/ul, HB more than 10 g/L, platelet count more than 80,000/ul in blood routine; 5. With normal renal and hepatic function; 6. With normal cardiac function that could tolerate the chemotherapy (without previous arrhythmia, uncontrollable congestive heart failure and acute myocardial infarction in recent 6 months); 7. Without nausea and vomiting 24 hours before the chemotherapy; 8. Without cognitive disorder; 9. Without previous diseases in central nervous system, such as uncontrollable brain metastases, epilepsia; 10. Without mental disorder (also do not belong to the following conditions: patients who have been used clozapine, risperidone, quetiapine, phenothiazine or butyrophen for 30 days, or need continue to use them during the study. Patients who have been used phenothiazine for long time, but it is acceptable if the phenothiazine is used as rescue); 11. Non abdominal concurrent chemoradiotherapy; 12. Without uncontrollable diabetes mellitus; 13. With good compliance: all of the patients could sign the informed consent and agree to participate in the clinical study. 

排除标准:

1、既往接受过化疗的病人,止吐方案中有奥氮平、帕洛诺司琼。 2、哺乳期或怀孕期妇女; 3、试验期间需要作放疗的患者; 4、有消化道梗阻或窄角性青光眼; 5、患有严重心脏病、肝肾疾病、代谢功能紊乱者; 6、服用精神类或镇静类药物者; 7、存在脑转移(有高颅症状)或有癫痫发作病史者; 8、24小时内使用过止吐药物或化疗前已出现呕吐者; 9、慢性酒精中毒或有药物精神依赖者; 10、对奥氮平、5-HT3拮抗剂过敏; 11、有化疗禁忌。 

Exclusion criteria:

1. chemotherapy with Olanzapine/palonosetron in antiemetic scheme; 2. Female in lactation or pregnancy; 3. Patients who will accepted radiotherapy during the trial; 4. With digestive tract obstruction or narrow angle glaucoma; 5. With serious cardiac, hepatic or renal disease and metabolic dysfunction; 6.With intake of mental or sedative medicine; 7. With brain metastases(high intracranial pressure symptom) or epilepsia attack history; 8. With intake of antiemetic medicine within 24 hours or has vomited before chemotherapy; 9. With chronic alcoholism or drug psychological dependence; 10. With allergic reaction to Olanzapine or 5-HT3 antagonist; 11. With chemotherapy contraindication. 

研究实施时间:

Study execute time:

From2014-11-01To 2015-10-31 

征募观察对象时间:

Recruiting time:

From2014-11-01To 2015-10-31 

干预措施:

Interventions:

组别:

试验组

样本量:

89

Group:

Experimental

Sample size:

干预措施:

奥氮平+帕洛诺司琼 +地塞米松

干预措施代码:

Intervention:

Olanzapine + Palonosetron + Dexamethsone

Intervention code:

组别:

对照

样本量:

89

Group:

Control

Sample size:

干预措施:

帕洛诺司琼

干预措施代码:

Intervention:

Palonositron

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

China 

市(区县):

辽宁 

Country:

Liaoning 

Province:

 

City:

 

单位(医院):

中国医科大学附属第四医院 

单位级别:

Fourth Affiliated Hospital, China Medical Universi 

Institution
hospital:

三级甲等  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

辽宁 

市(区县):

 

Country:

China 

Province:

Liaoning 

City:

 

单位(医院):

中国医科大学盛京医院 

单位级别:

三级甲等 

Institution
hospital:

Shengjing Hospital of China Medical University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

辽宁 

市(区县):

 

Country:

China 

Province:

Liaoning 

City:

 

单位(医院):

辽宁省人民医院 

单位级别:

三级甲等 

Institution
hospital:

The people's hospital of Liaoning Province  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

辽宁 

市(区县):

 

Country:

China 

Province:

Liaoning 

City:

 

单位(医院):

沈阳市第五人民医院 

单位级别:

三级甲等 

Institution
hospital:

The Shenyang fifth people's hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

辽宁 

市(区县):

 

Country:

China 

Province:

Liaoning 

City:

 

单位(医院):

沈阳市第四人民医院 

单位级别:

三级甲等 

Institution
hospital:

Shenyang the fouth hospital of people  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

辽宁 

市(区县):

 

Country:

China 

Province:

Liaoning 

City:

 

单位(医院):

葫芦岛市中心医院 

单位级别:

三级甲等 

Institution
hospital:

Central Hospital of Huludao City  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

辽宁 

市(区县):

 

Country:

China 

Province:

Liaoning 

City:

 

单位(医院):

铁岭市中心医院 

单位级别:

三级甲等 

Institution
hospital:

Central hospital of Tieling City  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

全程恶心、呕吐的完全控制率

指标类型:

主要指标 

Outcome:

complete response(CR) of ovreall phase

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

奥氮平的安全性和有效性

指标类型:

主要指标 

Outcome:

safety and effectiveness of Olanzapine

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

帕洛诺司琼的安全性和有效性

指标类型:

次要指标 

Outcome:

safety and effectiveness of Palonosetron

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

不良反应

指标类型:

副作用指标 

Outcome:

adverse events

Type:

Adverse events 

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:

Bliid

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age years

性别:

Gender:

随机方法(请说明由何人用什么方法产生随机序列):

随机表由研究者用excel软件自动生成

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

The random form was automatic generated by the researchers useing Excel software

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):

中国医科大学附属第四医院

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

the Fourth Affiliated Hospital of China Medical University

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:

中国医科大学附属第四医院

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

the Fourth Affiliated Hospital of China Medical University

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2014-08-11
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