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洛铂联合5-FU诱导化疗+洛铂配合IMRT同时期放化疗治疗局部中晚期鼻咽癌的有效性和安全性的前瞻性、单臂、开放临床研究
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注册号:

Registration number:

ChiCTR-ONC-12002060 

最近更新日期:

Date of Last Refreshed on:

2015-09-13 

注册时间:

Date of Registration:

2012-03-31 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

洛铂联合5-FU诱导化疗+洛铂配合IMRT同时期放化疗治疗局部中晚期鼻咽癌的有效性和安全性的前瞻性、单臂、开放临床研究 

Public title:

The effectiveness fety of neoadjuvant chemotherapy of lobaplatin combined with 5-FU, concurrent chemotherapy of lobaplatin IMRT in local-regionally advanced nasopharyngeal carcinoma : a prospective, non-controlled clinical trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

洛铂联合5-FU诱导化疗+洛铂配合IMRT同时期放化疗治疗局部中晚期鼻咽癌的有效性和安全性的前瞻性、单臂、开放临床研究 

Scientific title:

The effectiveness fety of neoadjuvant chemotherapy of lobaplatin combined with 5-FU, concurrent chemotherapy of lobaplatin IMRT in local-regionally advanced nasopharyngeal carcinoma : a prospective, non-controlled clinical 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:

夏伟雄 

研究负责人:

郭翔 

Applicant:

Xia Weixiong 

Study leader:

Guo Xiang 

申请注册联系人电话:

Applicant telephone:

+86 15013210286 

研究负责人电话:

Study leader's telephone:

+86 020 87343359 

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:

xiangyq@ucc.org.cn 

研究负责人电子邮件:

Study leader's E-mail:

guoxiang@ucc.org.cn 

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:

中国广州市东风东路651号鼻咽科 

研究负责人通讯地址:

中国广州市东风东路651号鼻咽科 

Applicant address:

651 Dongfeng East Road, Guangzhou, China 

Study leader's address:

651 Dongfeng East Road, Guangzhou, China 

申请注册联系人邮政编码:

Applicant postcode:

510060 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

中山大学肿瘤防治中心 

Applicant's institution:

Sun Yat-sen University Cancer Center 

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-2012002 

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:

Chinese Ethics Committee of Registering Clinical Trials 

伦理委员会批准日期:

Date of approved by ethic committee:

2012-03-26 

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:

中山大学肿瘤防治中心鼻咽科 

Primary sponsor:

Nasopharyngeal Carcinoma Department of Sun Yat-sen University Cancer Center 

研究实施负责(组长)单位地址:

中国广州市东风东路651号鼻咽科 

Primary sponsor's address:

651 Dongfeng East Road, Guangzhou, 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):

广州市

市(区县):

Country:

China

Province:

Guangzhou

City:

单位(医院):

中山大学肿瘤防治中心鼻咽科

具体地址:

中国广州市东风东路651号鼻咽科

Institution
hospital:

Nasopharyngeal Carcinoma Department of Sun Yat-sen University Cancer Center

Address:

651 Dongfeng East Road, Guangzhou, China

经费或物资来源:

自筹 

Source(s) of funding:

Self-financing 

研究疾病:

鼻咽癌 

Target disease:

Nasopharyngeal Carcinoma 

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:

II期临床试验 

Study phase:

研究目的:

在鼻咽癌高发区,通过前瞻性、单臂、开放的临床试验,评价洛铂联合5-FU+洛铂配合IMRT同时期放化疗治疗局部中晚期鼻咽癌的有效性及安全性。 

Objectives of Study:

To evaluate the effectiveness fety of neoadjuvant chemotherapy of lobaplatin combined with 5-FU, concurrent chemotherapy of lobaplatin IMRT in local-regionally advanced nasopharyngeal carcinoma. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

1、病理证实的WHO II 型或III型鼻咽癌;无其他恶性肿瘤病史,但非黑色素瘤的皮肤癌、原位宫颈癌、或已经治愈的早期前列腺癌除外 2、分期为T3-4N0-1M0, T1-4N2-3M0(UICC 7th edition) 3、 年龄18-60岁 4、 无严重心、肺、肝、肾等重要器官功能障碍 5、 白细胞≥4.0×109 ,中性粒细胞≥1.5×109 ,血小板≥100×109,血红蛋白≥90g/L,转氨酶低于2倍正常值,肌酐清除率>60ml/min 6、 签署知情同意书 

Inclusion criteria

1. Histologic diagnosis of nasopharyngeal carcinoma; 2. Aged between 18 60 years; 3. T3-4N0-1M0, T1-4N2-3M0 (UICC 7th edition); 4. KPS>=80; 5. No distant metastasis; 6. Laboratory parameters: Bone marrow function: WBC>=4.0*10^9/L, ANC>=1.5*10^9/L; PLT >=100*10^9/L; HB>=90g/L; Hepatic function: STB, CB<=ULN*1.5; ALT AST<=ULN*1.5; Renal function: Cr<=ULN; Coagulation function: PT INR)<=ULN*1.5; 7. Without the malignant tumor of other tissue(excluding cerical cancer, bal cell carcinoma or squamous carcinoma); 8. Without other anti-cancer therapy (including steroids); 9. Without other serious disease limitted in the trial; 10. Voluntary to participate sign informed consent document. 

排除标准:

1、 已行抗肿瘤治疗,包括化疗、放疗、手术 2、 治疗前发现远处转移 3、 已知或怀疑对化疗药物铂类过敏 4、 不同意签署知情同意书 5、 由于心理、社会、家庭及地理原因不能配合定期随 6、 伴有严重不可控制的感染或内科疾病 7、根据研究者的判断,有严重的危害患者安全或影响患者完 成研究的伴随疾病 8、 有影响给药、分布、代谢、排泄等因素,如有精神异常、中枢神经系统异常、慢性腹泻、腹水、胸水等 9、 器官移植后长期使用免疫抑制剂者 10、 入组前有其他恶性肿瘤病史者,但非黑色素瘤的皮肤癌、原位宫颈癌无法耐受放化疗、或已经治愈的早期前列腺癌除外 11、 围产期女性 

Exclusion criteria:

1. Distant metastases; 2. Previously treated (surgery, chemotherapy, radiotherapy, EGFR targeted therapy or immunotherapy); 3. Second malignancy within 5 years; 4. Precious therapy with an investigational agent; 5. Uncontrolled seizure disorder or other serious neurologic disease; 6. Allergic reaction (>=Grade III) to any drug including in this study; 7. Clinically significant cardiac or respiratory disease; 8. Creatinine clearance <30ml/min; 9. Drug or alcohol addiction; 10. Do not have full capacity for civil acts; 11. With severe complications or active infection; 12. Concurrent immunotherapy or hormone therapy for other diseases; 13. Pregnancy or lactation. 

研究实施时间:

Study execute time:

From2012-04-01To 2013-06-30 

干预措施:

Interventions:

组别:

1

样本量:

59

Group:

1

Sample size:

干预措施:

洛铂联合5-FU诱导化疗+洛铂配合IMRT同时期放化疗

干预措施代码:

Intervention:

Neoadjuvant chemotherapy of lobaplatin combined with 5-FU, concurrent chemotherapy of lobaplatin and IMRT

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

测量指标:

Outcomes:

指标中文名:

客观缓解率(ORR)

指标类型:

主要指标 

Outcome:

Objective response rate

Type:

Primary 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 (PFS)

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:

总生存期

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:

安全性评估

指标类型:

次要指标 

Outcome:

safety

Type:

Secondary 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 18 years
最大 Max age 60 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):

单臂临床试验

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

single arm

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):

国家抗肿瘤药物临床试验基地(GCP)

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

State anti-tumor drug clinical research base

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:

国家抗肿瘤药物临床试验基地(GCP)

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

State anti-tumor drug clinical research base

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2012-03-31
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