Today is 2020-09-28

The clinical study of temozolomide injection combined with hyperfration radiotherapy in the treatment of brain metastases
download

注册号:

Registration number:

ChiCTR1900027968 

最近更新日期:

Date of Last Refreshed on:

2019-12-09 

注册时间:

Date of Registration:

2019-12-07 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

替莫唑胺注射液联合大分割放疗治疗脑转移瘤的临床研究 

Public title:

The clinical study of temozolomide injection combined with hyperfration radiotherapy in the treatment of brain metastases 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

替莫唑胺注射液联合大分割放疗治疗脑转移瘤的临床研究 

Scientific title:

The clinical study of temozolomide injection combined with hyperfration radiotherapy in the treatment of brain metastases 

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:

王艺茜 

研究负责人:

王艺茜 

Applicant:

Yiqian Wang 

Study leader:

Yiqian Wang 

申请注册联系人电话:

Applicant telephone:

+86 18098873717 

研究负责人电话:

Study leader's telephone:

+86 18098873717 

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:

18098873717@163.com 

研究负责人电子邮件:

Study leader's E-mail:

18098873717@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:

辽宁省大连市西岗区中山路222号 

研究负责人通讯地址:

辽宁省大连市西岗区中山路222号 

Applicant address:

222 Zhongshan Road, Xigang District, Dalian, Liaoning, China 

Study leader's address:

222 Zhongshan Road, Xigang District, Dalian, Liaoning, 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:

大连医科大学附属第一医院 

Applicant's institution:

The First Affiliated Hospital of Dalian Medical University 

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:

PJ-KY-2019-122(X) 

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:

大连医科大学附属第一医院伦理委员会 

Name of the ethic committee:

Ethics Committee of the First Affiliated Hospital of Dalian Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-11-28 

伦理委员会联系人:

俆蕾 

Contact Name of the ethic committee:

Lei Xu 

伦理委员会联系地址:

辽宁省大连市西岗区中山路222号 

Contact Address of the ethic committee:

222 Zhongshan Road, Xigang District, Dalian, Liaoning, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 0411-83635963-3027 

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:

大连医科大学附属第一医院 

Primary sponsor:

The First Affiliated Hospital of Da lian Medical University 

研究实施负责(组长)单位地址:

辽宁省大连市西岗区中山路222号 

Primary sponsor's address:

222 Zhongshan Road, Xigang District, Dalian, 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):

辽宁省

市(区县):

大连市

Country:

China

Province:

Liaoning

City:

Dalian

单位(医院):

大连医科大学附属第一医院

具体地址:

西岗区中山路222号

Institution
hospital:

The First Affiliated Hospital of Da lian Medical University

Address:

222 Zhongshan Road, Xigang District

经费或物资来源:

江苏恒瑞医药股份有限公司 

Source(s) of funding:

Jiangsu Hengrui Pharmaceutical Co. Ltd 

研究疾病:

脑转移瘤 

Target disease:

brain metastases 

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:

II期临床试验 

Study phase:

研究目的:

主要目的:评价替莫唑胺注射液联合大分割放疗治疗脑转移病灶的客观缓解率; 次要目的:1、评价替莫唑胺注射液联合大分割放疗用于脑转移瘤患者的:疾病控制率(DCR)、无进展生存期(PFS)、生活质量;2、评价药物安全性。 

Objectives of Study:

The primary end point: ObjectiveResponseRateThe further end pointDisease Control RateProgression-Free Survival、Quality of life score、and safety。 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

1.年龄:18岁~75岁(包含18和75岁),性别不限; 2.具有经组织病理学或细胞学证实的原发癌并伴随脑转移,并且能够提供详细的原发癌病理报告; 3.经影像学检查确定脑转移,依据 RECIST 1.1 标准,至少有一个脑部可测量/评价的靶病灶; 4.既往未接受过替莫唑胺治疗,或替莫唑胺停药6个月后进展,或替莫唑胺辅助停药一年后进展; 5.既往放化疗、靶向治疗、免疫治疗等线数不限, 6.卡氏(KPS)评分≥60分; 7.预计生存期≥ 6个月; 8.主要器官功能正常,即符合下列标准: (1)血常规检查须符合: a.白细胞≥3.5×109/L b.中性粒细胞 ≥1.5×109/L; c.血红蛋白≥ 90 g/L; d.血小板≥100×109/L; (2)生化检查须符合以下标准: a.TBIL ≤1.5ULN; b.ALT、AST≤2.5 ULN(如肝功能异常因肝转移所致,则≤5ULN); c.血清肌酐≤1.5ULN,尿素氮≤1.5ULN; (3)凝血功能须符合:INR≤1.5且APTT≤1.5ULN; 9.患者自愿加入本研究,签署知情同意书,依从性好,配合随访。 

Inclusion criteria

1. Aged from 18-75 years. male or female; 2. Has histopathological or cytologically proven primary cancer with accompanying brain metastasesProvide a detailed report of the pathology of the primary cancer; 3. Determine brain metastases by imaging examination, according to RECIST 1.1 standard, at least one target lesion that can be measured / evaluated in the brain. 4. No temozolomide treatment has been performed before, or disease progression occurred after temozolomide discontinuation for 6 months or disease progression occurred after stopping adjuvant therapy by temozolomide for 1 year. 5. Previous radiotherapy and chemotherapy, targeted therapy, immunotherapy are not limited 6. KPS >= 60. 7. Life expectancy >= 6 months. 8. The functions of vital organs meet the following requirements. (1) Blood routine parameters: a. WBC >= 3.5 x 10^9/L b. Neutrophils >= 1.5 x 10^9/L c. Hb >= 90g/L d. PLT >= 100 x 10^9/L (2) Blood biochemical parameters: a. TBIL <= 1.5ULN b. ALT and AST <= 2.5 ULN (if the abnormal liver function was caused by liver metastasis, ALT and AST <= 5 ULN can be accepted) c. Cr <= 1.5 x ULN, BUN <= 1.5 x ULN (3) Coagulation function: INR <= 1.5 and APTT <= 1.5ULN 9. Subjects sign informed consent and voluntarily comply with visits, treatment protocols, laboratory tests defined by the schedule and other requirements for the study.  

排除标准:

1. 原发癌为中枢系统肿瘤,包括但不限于以下:低级别脑胶质瘤、高级别脑胶质瘤; 2. 已证实对替莫唑胺和/或其辅料过敏者; 3. 全身治疗评价脑转移病灶PR者需暂缓头部放疗; 4. 具有明确的出血倾向的患者,包括但不限于下列情况:有局部活动性溃疡病灶,且大便潜血(++)不可入组,2个月内有黑便、呕血病史者; 5. 具有精神类药物滥用史且无法戒除者或有精神障碍的患者; 6. 4周内参加过其他药物临床试验的患者; 7. 存在活动性感染,需全身治疗; 8. 乙肝表面抗原阳性(HBsAg)者,且外周血乙肝病毒脱氧核糖核酸(HBV-DNA)滴度检测≥1×103拷贝数/mL的患者;若HBsAg阳性,且外周血HBV-DNA<1×103拷贝数/mL,如果研究者认为患者慢性乙肝处于稳定期且不会增加患者风险,则患者有资格入选。丙型肝炎病毒(HCV)抗体阳性或人免疫缺陷病毒(HIV)抗体阳性; 9. 入组前6个月内发生严重的心脑血管动脉血栓栓塞的患者(例如,心肌梗死、不稳定心绞痛、脑卒中); 10. 筛选期育龄女性血妊娠试验为阳性(育龄期患者必须同意在试验期间采取有效的避孕措施); 11. 怀孕或哺乳期妇女; 12. 根据研究者判断,存在其他严重危害患者安全或影响其完成研究的伴随疾病、既往病史或其他因素。 

Exclusion criteria:

Patients with any of the following cannot be recruited in this study: 1. The primary focus is central system tumor, including but not limited to LGG and HGG. 2. Patients with allergy to temozolomide and/or its excipients. 3. Patients evaluated of PR for brain metastatic lesions after systemic treatment need Suspend head radiotherapy. 4. Patients with a clear bleeding tendency, including but not limited to having local active ulcer lesion and fecal occult blood(++), and patients with history of black stool and hematemesis within 2 months. 5. Patients with a history of psychoactive drug abuse and cannot give up, or patients with mental disorders. 6. Patients who have participated in clinical trials of other drugs within 4 weeks. 7. Patients with active infection and required systemic treatment. 8. Patients with positive HBsAg and peripheral blood HBV-DNA >= 1x103copies/mL . Patients with positive HBsAg and peripheral blood HBV-DNA < 1 x 103copies/mL can be recruited only when their chronic hepatitis B was considered stable and no increasing risk by the investigator. Patients with positive HCV or HIV. 9. Patients with severe cardiovascular and cerebrovascular thromboembolism within 6 months before recruiting.(e.g. myocardial infarction, unstable angina, stroke) 10. Female patients with positive blood pregnancy test during screening(patients of childbearing age must agree to take effective contraceptive measures during the trial). 11. Pregnant or nursing women. 12. According to the judgment of the investigator, there are other concomitant diseases, previous history or other factors that seriously endanger the safety of the patient or affect the completion of the study. 

研究实施时间:

Study execute time:

From2019-12-01To 2022-12-01 

征募观察对象时间:

Recruiting time:

From2019-12-01To 2020-12-01 

干预措施:

Interventions:

组别:

单组

样本量:

40

Group:

single arm

Sample size:

干预措施:

注射用替莫唑胺联合大分割放疗

干预措施代码:

Intervention:

temozolomide combined with hyperfration radiotherapy

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):

大连 

Country:

China 

Province:

Liaoning 

City:

Dalian 

单位(医院):

大连医科大学附属第一医院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital of Dalian Medical University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

客观缓解率

指标类型:

主要指标 

Outcome:

ObjectiveResponseRate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疾病控制率

指标类型:

次要指标 

Outcome:

Disease Control Rate

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:

生活质量评分

指标类型:

次要指标 

Outcome:

Quality of life score

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

药物安全性

指标类型:

次要指标 

Outcome:

Drug 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:

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:

标本中文名:

尿液

组织:

Sample Name:

urine

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 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):

非随机化

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

non-randomized

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

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):

no stated

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

no stated

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:

no stated

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

no stated

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-12-07
return list