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同步放化疗联合巩固化疗治疗腹主动脉旁淋巴结转移宫颈癌的II期临床研究
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注册号:

Registration number:

ChiCTR1900020654 

最近更新日期:

Date of Last Refreshed on:

2019-01-12 

注册时间:

Date of Registration:

2019-01-12 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

同步放化疗联合巩固化疗治疗腹主动脉旁淋巴结转移宫颈癌的II期临床研究 

Public title:

Phase II study for concurrent chemoradiotherapy combined with consolidation chemotherapy for cervical cancer with para-aortic lymph node metastasis. 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

同步放化疗联合巩固化疗治疗腹主动脉旁淋巴结转移宫颈癌的II期临床研究 

Scientific title:

Phase II study for concurrent chemoradiotherapy combined with consolidation chemotherapy for cervical cancer with para-aortic lymph node metastasis. 

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:

周方 

研究负责人:

周方 

Applicant:

Fang Zhou 

Study leader:

Fang Zhou 

申请注册联系人电话:

Applicant telephone:

+86 18653540841 

研究负责人电话:

Study leader's telephone:

+86 18653540841 

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:

fangzhoustar@126.com 

研究负责人电子邮件:

Study leader's E-mail:

fangzhoustar@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:

烟台市芝罘区毓璜顶东路20号烟台毓璜顶医院 

研究负责人通讯地址:

烟台市芝罘区毓璜顶东路20号烟台毓璜顶医院 

Applicant address:

20 Yuhuangding Road East, Zhifu District, Yantai, Shandong, China 

Study leader's address:

20 Yuhuangding Road East, Zhifu District, Yantai, Shandong, 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:

烟台毓璜顶医院 

Applicant's institution:

Yantai Yuhuangding Hospital 

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:

116 

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:

烟台毓璜顶医院伦理委员会 

Name of the ethic committee:

Yantai Yuhuangding Hospital Ethics Committee  

伦理委员会批准日期:

Date of approved by ethic committee:

2018-11-01 

伦理委员会联系人:

王璇 

Contact Name of the ethic committee:

Wang Xuan 

伦理委员会联系地址:

烟台市芝罘区毓璜顶东路20号烟台毓璜顶医院 

Contact Address of the ethic committee:

Yantai Yuhuangding Hospital, 20 Yuhuangding Road East, Zhifu District, Yantai, Shandong, 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:

烟台毓璜顶医院 

Primary sponsor:

Yantai Yuhuangding Hospital 

研究实施负责(组长)单位地址:

烟台市芝罘区毓璜顶东路20号 

Primary sponsor's address:

20 Yuhuangding Road East, Zhifu District, Yantai, Shandong, 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):

山东省

市(区县):

烟台市

Country:

China

Province:

Shandong

City:

Yantai

单位(医院):

烟台毓璜顶医院

具体地址:

烟台市芝罘区毓璜顶东路20号

Institution
hospital:

Yantai Yuhuangding Hospital

Address:

20 Yuhuangding Road East, Zhifu District, Yantai, Shandong, China

经费或物资来源:

横向课题 

Source(s) of funding:

horizontal project 

研究疾病:

宫颈癌 

Target disease:

Cervical cancer 

研究疾病代码:

 

Target disease code:

 

研究类型:

治疗研究 

Study type:

Treatment study 

研究所处阶段:

II期临床试验 

Study phase:

研究目的:

本研究拟采用体外延伸野调强加腔内放疗治疗未手术局部晚期子宫颈癌腹主动脉旁淋巴结转移患者,并放疗后行4-6周期巩固化疗,研究患者治疗期间毒副反应及生存获益情况。 

Objectives of Study:

The purpose of this study was to treat patients with unoperated advanced cervical cancer with paraventral lymph node metastasis by external extended field modulation and intracavitary radiotherapy, and to undergo 4-6 cycles of consolidation chemotherapy after radiotherapy. Side effects and survival benefits during treatment were studied. 

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)自愿作为受试对象,签署知情同意书; (2)年龄18-65岁的病人; (3)有病理组织明确诊断为宫颈癌,且腹主动脉淋巴结阳性的未手术患者; (4)体力状况评分为0、1、2; (5)活检证实的宫颈浸润性鳞癌、腺癌、或腺鳞癌 (6)FIGO分期IB-IVA期 (7)对于骨髓、肝功、肾脏功能进行检测: 骨髓功能WBC ≥ 3.5 x 10E9/L ;中性粒细胞≥ 1.5 x 10E9/L;血小板 ≥ 100x 10E9/L;血红蛋白 ≥ 100 g/L (使用输血或其它方法均可以接受) 肝功在正常范围内 :谷丙转氨酶(alanine aminotransferase, ALT)、谷草转氨酶(aspartate aminotransferase, AST) < 1.5倍的正常值上限,碱性磷酸酶(alkaline phosphatase, ALP) < 2.5倍的正常值上限,胆红素 <正常值上限。 肾功能在正常范围内:肌酐清除率(creatinine clearance rate, CCr ) > 60 ml/min。 计算公式: CCr=(140-年龄)×体重(kg)/[72×Scr(mg/dl) ] 或 CCr=[(140-年龄)×体重(kg)]/[0.818×Scr(umol/L)] 凝血酶原国际比值( INR ) ≤ 1.5  

Inclusion criteria

1. voluntarily as the subject, sign the informed consent; 2. patients aged 18-65 years; 3. pathologic tissues were clearly diagnosed as cervical cancer,unoperated advanced cervical cancer with paraventral lymph node metastasis; 4. physical condition score is 0, 1 and 2; 5. invasive cervical squamous cell carcinoma, adenocarcinoma, or adenocarcinoma confirmed by biopsy; 6. FIGO stage IB-IIA stage; 7. detection of bone marrow, liver function and renal function: (1) bone marrow function WBC is greater than or equal to 3.5 x 10^9/L; Neutrophilic granulocytes are greater than or equal to 1.5 x 10^9/L; Platelets are greater than or equal to 100x 10^9/L. Hemoglobin greater than or equal to 100 g/L (acceptable with blood transfusion or other methods); (2) the liver function was in the normal range: alanine aminotransferase (ALT), aspartate aminotransferase (AST) < 1.5 times the upper limit of normal value, alkaline phosphatase (ALP) < 2.5 times the upper limit of normal value, and bilirubin < the upper limit of normal value; (3) renal function within the normal range: creatinine clearance rate (CCr) > 60ml /min; Calculation formula: CCr=(140-age) x weight (kg)/[72 x Scr(mg/dl)] or CCr=[(140-age) x weight (kg)]/[0.818 x Scr(umol/L)]; (4) the original international ratio of thrombin (INR) is less than or equal to 1.5.  

排除标准:

(1)妊娠、哺乳期妇女; (2)对铂类药物过敏的患者; (3)存在其他恶性肿瘤病史; (4)血常规异常:中性粒细胞<1.5×109/L,HB <80g/L,PLT<80×109/L;肝功异常:转氨酶高于正常2倍;肾功、小便常规及心电图异常; (5)参加其它临床试验者; (6)在最近3年内曾进行过全身化疗 (7)以前曾有过盆腔或腹部放射治疗史,对本次放疗可能造成照射野的重叠 (8)有其它器官远处转移病灶 (9)有以下严重活动性的并发疾病:①在过去的6个月内有不稳定的心绞痛或/和需要住院治疗的充血性心力衰竭;②在最近的6各月内有透壁性心肌梗死发生;③严重动脉硬化及高血压;④注册时有急性的细菌或真菌感需要静脉使用抗生素治疗;⑤慢性阻塞性肺病恶化或其他呼吸道疾病需要住院治疗或妨碍研究的进行;⑥肝功能低下导致黄疸或凝血机制障碍,严重肾功能不全;⑦严重精神障碍患者;⑧严重造血系统疾病;⑨获得性免疫缺陷病 ( 确诊为艾滋病的患者,或疑似有艾滋病的患者而拒绝进行HIV检测 );⑩其他的免疫功能低下状态 (例如器官移植、长期使用糖皮质激素)。 (10)研究者认为其他不适合入组者。  

Exclusion criteria:

(1) women during pregnancy and lactation; (2) patients who are allergic to platinum drugs; (3) a history of other malignant tumors; (4) abnormal blood routine: neutrophil < 1.5x10^9/L, HB <80g/L, PLT< 80x10^9/L; Abnormal liver function: transaminase was 2 times higher than normal; Renal function, urine routine and ecg abnormality; (5) participating in other clinical trials; (6) have had systemic chemotherapy in the last 3 years; (7) there has been a history of pelvic or abdominal radiotherapy before, which may cause the irradiation field overlapping; (8) there are distant metastatic lesions in other organs; (9) there are the following severe active concomitant diseases: edema has unstable angina or/and congestive heart failure requiring hospitalization in the past 6 months;Injection occurred in the last 6 months during a transmural myocardial infarction;Severe arteriosclerosis and hypertension;An acute bacterial or fungal infection at the time of registration requires intravenous antibiotic therapy;Chronic obstructive pulmonary disease or other respiratory diseases should be treated in the hospital or in the way of research.Liver dysfunction leads to jaundice or coagulation disorders and serious renal insufficiency;Patients with severe mental disorders;Severe haematopoietic system disease;Acquired immunodeficiency disease (HIV testing is denied to patients who have been diagnosed with or suspected to have HIV);Other immunocompromised (e.g., organ transplantation, long-term use of glucocorticoids); (10) other participants were deemed unsuitable by the researchers. 

研究实施时间:

Study execute time:

From2018-11-01To 2021-11-01 

干预措施:

Interventions:

组别:

巩固化疗组

样本量:

40

Group:

Case series

Sample size:

干预措施:

4-6周期巩固化疗

干预措施代码:

Intervention:

4-6 cycles of consolidation chemotherapy

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

山东省 

市(区县):

烟台市 

Country:

China 

Province:

Shandong 

City:

Yantai 

单位(医院):

烟台毓璜顶医院 

单位级别:

三级甲等医院 

Institution
hospital:

Yantai Yuhuangding Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

无疾病进展生存率

指标类型:

主要指标 

Outcome:

Disease-free progression survival (PFS)

Type:

Primary 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:

主要指标 

Outcome:

Overall survival (OS)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

近期毒副反应

指标类型:

主要指标 

Outcome:

Recent adverse reactions

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肿瘤进展时间

指标类型:

次要指标 

Outcome:

Tumor progression time (TTP)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

远期毒副反应

指标类型:

次要指标 

Outcome:

Long-term toxic and side effects

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 65 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):

N/A

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

N/A

盲法:

N/A

Blinding:

N/A

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

ResMan

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

ResMan

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:

病例记录表

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

Case Record Form, CRF

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-01-12
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