ChiCTR2500110542 版本V1.0 版本创建时间2025/10/15 15:02:12 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2500110542 

最近更新日期：

Date of Last Refreshed on：

 2025-10-15 15:02:04 

注册时间：

Date of Registration：

 2025-10-15 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

A Comparative study between Induction Chemotherapy Followed by Concurrent Chemoradiation versus Concurrent Chemoradiation in the Management of Locally Advanced Uterine Cervical Cancer

Public title：

A Comparative study between Induction Chemotherapy Followed by Concurrent Chemoradiation versus Concurrent Chemoradiation in the Management of Locally Advanced Uterine Cervical Cancer

注册题目简写：

English Acronym：

研究课题的正式科学名称：

A Comparative study between Induction Chemotherapy Followed by Concurrent Chemoradiation versus Concurrent Chemoradiation in the Management of Locally Advanced Uterine Cervical Cancer

Scientific title：

A Comparative study between Induction Chemotherapy Followed by Concurrent Chemoradiation versus Concurrent Chemoradiation in the Management of Locally Advanced Uterine 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：

EL Sayed Mostafa Ali 

研究负责人：

Aya Mohamed Atya EI Morsy 

Applicant：

EL Sayed Mostafa Ali 

Study leader：

Aya Mohamed Atya EI Morsy 

申请注册联系人电话：

Applicant telephone：

 +20 10 15705907

研究负责人电话：

Study leader's
telephone：

+20 10 01638744

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：

 ramyatya2000@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

 ayaatya989@gmail.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：

Naser City, Sohag, Egypt

研究负责人通讯地址：

Naser City, Sohag, Egypt

Applicant address：

Naser City, Sohag, Egypt

Study leader's address：

Naser City, Sohag, Egypt

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：

Sohag university

Applicant's institution：

Sohag university

研究负责人所在单位：

Sohag university

Affiliation of the Leader：

Sohag 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：

 Soh-Med-25-9——5MD

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：

Ethical Committee of Faculty of Medicine, Sohag University

Name of the ethic committee：

Ethical Committee of Faculty of Medicine, Sohag University

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-09-10 00:00:00

伦理委员会联系人：

Prof. Engy Mohamed Ahmed

Contact Name of the ethic committee：

Prof. Engy Mohamed Ahmed

伦理委员会联系地址：

Naser City, Sohag, Egypt

Contact Address of the ethic committee：

Naser City, Sohag, Egypt

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +20 93 4602963

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：

Sohag university

Primary sponsor：

Sohag university

研究实施负责（组长）单位地址：

Naser City, Sohag, Egypt

Primary sponsor's address：

Naser City, Sohag, Egypt

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

Egypt

省(直辖市)：

Sohag

市(区县)：

Country：

Egypt

Province：

Sohag

City：

单位(医院)：

Sohag university

具体地址：

Naser City, Sohag, Egypt

Institution
hospital：

Sohag university

Address：

Naser City, Sohag, Egypt

经费或物资来源：

Sohag university

Source(s) of funding：

Sohag university

研究疾病：

Cancer cervix  

Target disease：

Cancer cervix

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：

3

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

This study aims to explore the efficacy and tolerability of induction chemotherapy followed by chemoradiation versus conventional therapy chemoradiation in patients with locally advanced uterine cervical cancer.  

Objectives of Study：

This study aims to explore the efficacy and tolerability of induction chemotherapy followed by chemoradiation versus conventional therapy chemoradiation in patients with locally advanced uterine cervical cancer.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.Age between 18 and 70 years; 2.Clinically staged as IB3–IVA according to the International Federation of Gynecology and Obstetrics (FIGO); 3.Histologically proved squamous cell carcinoma or adenocarcinoma of the uterine cervix; 4.Performance status 0–2 according to Word Health Organization (WHO) criteria; 5.Normal hematological, renal and hepatic function.

Inclusion criteria

1.Age between 18 and 70 years; 2.Clinically staged as IB3–IVA according to the International Federation of Gynecology and Obstetrics (FIGO); 3.Histologically proved squamous cell carcinoma or adenocarcinoma of the uterine cervix; 4.Performance status 0–2 according to Word Health Organization (WHO) criteria; 5.Normal hematological, renal and hepatic function.

排除标准：

1.Severe systemic or uncontrolled disease (infection, central nervous system, metabolic, etc.) that precluded the use of chemotherapy; 2.Pre-existing high grade neuropathy of any cause; 3.Histologically proved small cell carcinoma, leiomyosarcoma, lymphoma and other histopathologies other than Squamous cell carcinoma & adenocarcinoma; 4.Mental illness; 5.Previous or concomitant malignancies.

Exclusion criteria：

1.Severe systemic or uncontrolled disease (infection, central nervous system, metabolic, etc.) that precluded the use of chemotherapy; 2.Pre-existing high grade neuropathy of any cause; 3.Histologically proved small cell carcinoma, leiomyosarcoma, lymphoma and other histopathologies other than Squamous cell carcinoma & adenocarcinoma; 4.Mental illness; 5.Previous or concomitant malignancies.

研究实施时间：

Study execute time：

从 From 2025-10-12 00:00:00至 To 2027-10-12 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-11-01 00:00:00 至 To 2026-04-12 00:00:00

干预措施：

Interventions：

组别：

A group

样本量：

 40

Group：

A group

Sample size：

干预措施：

Patients will receive induction chemotherapy consisted of intravenous paclitaxel 175mg/m^2 day 1 + (Cisplatin 75mg/m^2 day 1 or Carboplatin AUC 5 day 1 according to pt is eligible to cisplatin or not) every 21 days for 3 cycles followed by reevaluation 3 weeks after the 3rd cycle of induction chemotherapy then to start standard chemoradiotherapy (consisted of weekly cisplatin 40 mg/ m^2 or Carboplatin AUC 2 for 5 weeks concurrent with External beam radiotherapy ) followed by brachytherapy

干预措施代码：

Intervention：

Patients will receive induction chemotherapy consisted of intravenous paclitaxel 175mg/m^2 day 1 + (Cisplatin 75mg/m^2 day 1 or Carboplatin AUC 5 day 1 according to pt is eligible to cisplatin or not) every 21 days for 3 cycles followed by reevaluation 3 weeks after the 3rd cycle of induction chemotherapy then to start standard chemoradiotherapy (consisted of weekly cisplatin 40 mg/ m^2 or Carboplatin AUC 2 for 5 weeks concurrent with External beam radiotherapy ) followed by brachytherapy

Intervention code：

组别：

B group

样本量：

 40

Group：

B group

Sample size：

干预措施：

Patients will receive standard chemoradiotherapy (consisted of weekly cisplatin 40 mg/m2 or Carboplatin AUC 2 for 5 weeks concurrent with External beam radiotherapy) followed by brachytherapy

干预措施代码：

Intervention：

Patients will receive standard chemoradiotherapy (consisted of weekly cisplatin 40 mg/m2 or Carboplatin AUC 2 for 5 weeks concurrent with External beam radiotherapy) followed by brachytherapy

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 Egypt

省(直辖市)：

 Sohag 

市(区县)：

  

Country：

Egypt

Province：

Sohag

City：

单位(医院)：

 Sohag university  

单位级别：

 University 

Institution
hospital：

Sohag university

Level of the institution：

University

国家：

 Egypt

省(直辖市)：

 Sohag 

市(区县)：

  

Country：

Egypt

Province：

Sohag

City：

单位(医院)：

 Sohag Cancer Center 

单位级别：

 N/A 

Institution
hospital：

Sohag Cancer Center

Level of the institution：

N/A

测量指标：

Outcomes：

指标中文名：

The clinical response rate at the end of induction chemotherapy

指标类型：

主要指标

Outcome：

The clinical response rate at the end of induction chemotherapy

Type：

Primary indicator

测量时间点：

2 Years

测量方法：

Measure time point of outcome：

2 Years

Measure method：

指标中文名：

Overall survival rate

指标类型：

主要指标

Outcome：

Overall survival rate

Type：

Primary indicator

测量时间点：

2 Years

测量方法：

Measure time point of outcome：

2 Years

Measure method：

指标中文名：

Progression free survival

指标类型：

次要指标

Outcome：

Progression free survival

Type：

Secondary indicator

测量时间点：

5 years

测量方法：

Measure time point of outcome：

5 years

Measure method：

指标中文名：

Disease-free survival

指标类型：

次要指标

Outcome：

Disease-free survival

Type：

Secondary indicator

测量时间点：

5 years

测量方法：

Measure time point of outcome：

5 years

Measure method：

指标中文名：

Adverse events associated with the treatment

指标类型：

次要指标

Outcome：

Adverse events associated with the treatment

Type：

Secondary indicator

测量时间点：

5 years

测量方法：

Measure time point of outcome：

5 years

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

Blood

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：

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 岁 years
最大 Max age 岁 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）：

Randomization will be performed using a computer-generated random number table

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

Randomization will be performed using a computer-generated random number table

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Open-label

Blinding：

Open-label

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

否No

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）：

none

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

none

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：

Data will be collected prospectively from all enrolled patients using case report forms (CRFs). Data will be entered into a password-protected electronic database. Only authorized research team members will have access to the data. Regular data verification will be performed to ensure accuracy and completeness.

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

Data will be collected prospectively from all enrolled patients using case report forms (CRFs). Data will be entered into a password-protected electronic database. Only authorized research team members will have access to the data. Regular data verification will be performed to ensure accuracy and completeness.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2025-10-15 15:02:04