Today is 2022-07-06

A Prospective Randomized Controlled Trial of Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiation Versus Concurrent Chemoradiation Therapy Alone in Advanced Cervical Cancer
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注册号:

Registration number:

ChiCTR2100054929 

最近更新日期:

Date of Last Refreshed on:

2022-06-19 

注册时间:

Date of Registration:

2021-12-29 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

宫颈癌新辅助化疗序贯同步放化疗对比宫颈癌单纯同步放化疗治疗中晚期宫颈癌前瞻性随机对照临床研究 

Public title:

A Prospective Randomized Controlled Trial of Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiation Versus Concurrent Chemoradiation Therapy Alone in Advanced Cervical Cancer 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

宫颈癌新辅助化疗序贯同步放化疗对比宫颈癌单纯同步放化疗治疗中晚期宫颈癌前瞻性随机对照临床研究 

Scientific title:

A Prospective Randomized Controlled Trial of Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiation Versus Concurrent Chemoradiation Therapy Alone in Advanced Cervical Cancer 

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:

刘红 

研究负责人:

张国楠 

Applicant:

Liu Hong 

Study leader:

Zhang Guonan 

申请注册联系人电话:

Applicant telephone:

+86 13693447854 

研究负责人电话:

Study leader's telephone:

+86 13881866599 

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:

liuhaotian12@163.com 

研究负责人电子邮件:

Study leader's E-mail:

zhanggn@hotmail.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:

四川省成都市人民南路四段55号 

研究负责人通讯地址:

四川省成都市人民南路四段55号 

Applicant address:

55 Fourth Section of Renmin Road South, Chengdu, Sichuan 

Study leader's address:

55 Fourth Section of Renmin Road South, Chengdu, Sichuan 

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:

四川省肿瘤医院 

Applicant's institution:

Sichuan Cancer 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:

SCCHEC-02-2021-099 

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:

四川省肿瘤医院医学科研与医疗新技术伦理委员会 

Name of the ethic committee:

Ethics Committee of Sichuan Cancer Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2021-12-21 

伦理委员会联系人:

李婷媛 

Contact Name of the ethic committee:

Li Tingyuan 

伦理委员会联系地址:

四川省成都市人民南路四段55号 

Contact Address of the ethic committee:

55 Fourth Section of Renmin Road South, Chengdu, Sichuan 

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:

四川省肿瘤医院 

Primary sponsor:

Sichuan Cancer Hospital 

研究实施负责(组长)单位地址:

四川省成都市人民南路四段55号 

Primary sponsor's address:

55 Fourth Section of Renmin Road South, Chengdu, Sichuan 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

四川

市(区县):

成都

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

四川省肿瘤医院

具体地址:

人民南路四段55号

Institution
hospital:

Sichuan Cancer Hospital

Address:

55 Fourth Section of Renmin Road South

经费或物资来源:

无 

Source(s) of funding:

No 

研究疾病:

宫颈癌 

Target disease:

Cervical 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:

III期临床试验 

Study phase:

研究目的:

比较分析宫颈癌新辅助化疗序贯同步放化疗对比宫颈癌同步放化疗治疗中晚期宫颈癌的临床疗效和安全性。 

Objectives of Study:

To determine whether neoadjuvant chemotherapy (NACT) with cisplatin and paclitaxel plus standard cisplatin-based chemoradiation with extended fields improves progression free survival rates compared to concurrent chemoradiation therapy (CCRT) alone in locally advanced cervical cancer.  

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:

1. 年龄≥18岁; 2. 经病理组织学检查诊断为宫颈癌Ib3-IIIb期(宫颈鳞癌,腺癌或腺鳞癌),依据国际妇产科协会(FIGO)指南2018年版; 3. 根据RECIST 1.1肿瘤评价标准,具有至少一个可测量病灶; 4. 无其他同时进行的抗癌治疗(包括如局部放疗、全身化疗及分子靶向治疗等)或既往治疗历史; 5. ECOG PS评分为0~1分; 6. 预计生存时间≥3个月; 7. 无明显血液系统疾病征象,入组前ANC≥1.5 x 10^9/L,血小板计数≥100 x 10^9/L,Hb≥90 g/L,WBC≥3.0 x 10^9/L,且无出血倾向; 8. 肝功能检查:总胆红素(TBIL)≤1.5倍正常值上限,谷丙转氨酶(ALT)、谷草转氨酶(AST)均≤2.5倍正常值上限;肾功能检查:血清肌酐(Cr)≤1.5 mg/dl,或计算的肌酐清除率≥50 ml/min; 9. 能理解本研究的情况,依从性好,配合随访,患者及(或)法定代理人自愿同意参加本试验并签署知情同意书。 

Inclusion criteria

1. >= 18 years old; 2. Patients must have histologically confirmed cervical cancer with adenocarcinoma, adenosquamous or squamous histology and FIGO 2018 Ib3-IIIb; 3. According to the RECIST 1.1 standard, the subject must have at least one measurable target lesion; 4. No prior treatment; 5. Expected survival period >= 3 months; 6. ECOG score: 0-1; 7. No obvious signs of hematological diseases, ANC >= 1.5 x 10^9/L, platelet count >= 100 x 10^9/L, Hb >= 90 g/L, WBC >= 3.0 x 10^9/L, and no bleeding tendency before enrollment; 8. Adequate hepato-renal function is needed, including: total bilirubin (TBIL)<= 1.5 x ULN (Gilbert syndrome allows <= 5 x ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 2.5 x ULN; serum creatinine (Cr) <= 1.5 x ULN or endogenous creatinine clearance >= 50 mL/min; 9. Patients voluntarily participated in the study and signed informed consent. 

排除标准:

1. 妊娠或哺乳期女性患者(育龄期女性须在首次给药前7d内明确妊娠试验为阴性,若为阳性,须行超声检查排除妊娠),育龄期受试者拒绝接受避孕措施; 2. 合并其他恶性肿瘤,治愈的皮肤基底细胞癌或皮肤鳞癌或其他任何部位的原位癌除外; 3. 存在任何骨髓异常增生及其他造血功能异常疾病; 4. 存在需系统治疗的活动性感染、HIV感染、病毒性肝炎; 5. 根据美国国立癌症研究所常见毒性反应标准(NCI-CTC)5.0版患有≥1级外周神经病变的受试者; 6. 严重的心血管疾病如近6月内发生的脑血管意外、心肌梗死、药物干预后仍不能控制的高血压、不稳定型心绞痛、心力衰竭(NYHA2-4级)以及心律不齐需药物干预者; 7. 对本试验使用药物或药物成分过敏或具有超敏反应史; 8. 筛选期30 d内曾接受其他任何试验药物治疗或参加过另一项干预性临床试验; 9. 会妨碍理解或做出知情同意或填写问卷的痴呆、精神状态改变或任何精神疾病; 10. 研究者认为不适合入组。 

Exclusion criteria:

1. Pregnant or breastfeeding female patients (women of child-bearing potential must confirm that the pregnancy test is negative within 7 days before the first administration. If it is positive, ultrasound examination must be performed to exclude pregnancy), or women of child-bearing potential who refused to receive contraceptive measures; 2. Combined with other malignant tumors, except for cured skin basal cell carcinoma or skin squamous cell carcinoma or carcinoma in situ of any other part; 3. Existence of any bone marrow dysplasia and other abnormal hematopoietic diseases; 4. Active infections, HIV infections, and viral hepatitis that require systematic treatment; 5. Patients with >= grade 1 peripheral neuropathy according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 5.0; 6. Had severe cardiovascular diseases such as cerebrovascular accident, myocardial infarction, hypertension that cannot be controlled after drug intervention, unstable angina pectoris, heart failure (NYHA 2-4) and arrhythmia that need drug intervention within 6 months; 7. It is known to have a history of allergies to research drugs or drug components; 8. Has participated in other anti-tumor intervention clinical trials within 30 days before the first medication; 9. Have a clear history of dementia, mental state changes or any mental illness that will hinder understanding or informed consent; 10. The investigator believes that the patient is not suitable for participating in this clinical research. 

研究实施时间:

Study execute time:

From2022-03-01To 2027-02-28 

征募观察对象时间:

Recruiting time:

From2022-03-01To 2024-02-29 

干预措施:

Interventions:

组别:

干预组

样本量:

143

Group:

Intervention group

Sample size:

干预措施:

新辅助化疗+同步放化疗

干预措施代码:

Intervention:

NACT+CCRT

Intervention code:

组别:

对照组

样本量:

143

Group:

Control group

Sample size:

干预措施:

单纯同步放化疗

干预措施代码:

Intervention:

CCRT

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川 

市(区县):

成都 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

四川省肿瘤医院 

单位级别:

三级甲等 

Institution
hospital:

Sichuan Cancer Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

无进展生存期

指标类型:

主要指标 

Outcome:

Progression free 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:

客观缓解率

指标类型:

次要指标 

Outcome:

Objective Response Rate (ORR)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生存期

指标类型:

次要指标 

Outcome:

Overall Survival (OS)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

不良事件发生率

指标类型:

次要指标 

Outcome:

Number of participants who experience one or more adverse events (AEs)

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:

组织:

Sample Name:

No

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

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 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):

根据随机量表随机将患者分为两组,接受治疗。

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

Patients were randomly divided into two groups according to the random number table.

盲法:

开放

Blinding:

Open-label

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

Yes

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):

N/A

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

N/A

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:

病人CRF表和spss数据库

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

CRF of Patients and spss data

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2021-12-29
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