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Combined neoadjuvant chemotherapy (NAC) and laparoscopic intraperitoneal hyperthermic chemotherapy (L-HIPEC) followed by R0 gastrectomy for locally advanced gastric cancer with serosal invasion (cT4-LAGC): A multicentric randomized controlled trial
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注册号:

Registration number:

ChiCTR1900024552 

最近更新日期:

Date of Last Refreshed on:

2019-07-16 

注册时间:

Date of Registration:

2019-07-16 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

新辅助化疗(NAC)与经腔镜腹腔内温热化疗(L-HIPEC)联合R0胃癌根治术治疗浆膜浸润局部进展期胃癌(cT4-LAGC)的多中心随机对照研究 

Public title:

Combined neoadjuvant chemotherapy (NAC) and laparoscopic intraperitoneal hyperthermic chemotherapy (L-HIPEC) followed by R0 gastrectomy for locally advanced gastric cancer with serosal invasion (cT4-LAGC): A multicentric randomized controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

新辅助化疗(NAC)与经腔镜腹腔内温热化疗(L-HIPEC)联合R0胃癌根治术治疗浆膜浸润局部进展期胃癌(cT4-LAGC)的多中心随机对照研究 

Scientific title:

Combined neoadjuvant chemotherapy (NAC) and laparoscopic intraperitoneal hyperthermic chemotherapy (L-HIPEC) followed by R0 gastrectomy for locally advanced gastric cancer with serosal invasion (cT4-LAGC): A multicentric randomized controlled 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:

倪震天 

研究负责人:

朱正纲 

Applicant:

Ni Zhentian 

Study leader:

Zhu Zhenggang 

申请注册联系人电话:

Applicant telephone:

+86 13482508978 

研究负责人电话:

Study leader's telephone:

+86 18917762000 

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:

351775759@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

zzg1954@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:

上海市瑞金二路197号 

研究负责人通讯地址:

上海市瑞金二路197号 

Applicant address:

197 Second Ruijin Road, Huangpu District, Shanghai, China 

Study leader's address:

197 Second Ruijin Road, Huangpu District, Shanghai, 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:

上海交通大学医学院附属瑞金医院 

Applicant's institution:

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine 

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:

(2019)临伦审第(71)号 

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:

上海交通大学医学院附属瑞金医院伦理委员会 

Name of the ethic committee:

Ethics committee of Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-04-30 

伦理委员会联系人:

杨伟国 

Contact Name of the ethic committee:

Yang Weiguo 

伦理委员会联系地址:

上海市瑞金二路197号 

Contact Address of the ethic committee:

197 Second Ruijin Road, Huangpu District, Shanghai, 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:

上海交通大学医学院附属瑞金医院 

Primary sponsor:

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine 

研究实施负责(组长)单位地址:

上海市瑞金二路197号 

Primary sponsor's address:

197 Second Ruijin Road, Huangpu District, Shanghai, 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):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海交通大学医学院附属瑞金医院

具体地址:

上海市瑞金二路197号

Institution
hospital:

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Address:

197 Second Ruijin Road, Huangpu District, Shanghai, China

国家:

中国

省(直辖市):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

复旦大学附属华山医院

具体地址:

上海市乌鲁木齐中路12号

Institution
hospital:

HuaShan hospital affiliated to Fudan University

Address:

12 Urumqi Road, Shanghai

国家:

中国

省(直辖市):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海交通大学医学院附属瑞金医院北院

具体地址:

上海市嘉定区希望路999号

Institution
hospital:

Ruijin Hospital North, Shanghai Jiao Tong University School of Medicine

Address:

999 Xiwang Road, Jiading District, Shanghai

经费或物资来源:

上海交通大学医学院附属瑞金医院临床研究课题 

Source(s) of funding:

Clinical research project of Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine 

研究疾病:

胃癌 

Target disease:

Gastric 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:

研究主要目的:有效预防局部进展期胃癌(cT4-LAGC)腹膜转移,提高患者生存率 研究次要目的: a. 评价L-HIPEC+NAC+手术与直接手术两种疗法对预防胃癌腹膜转移的客观有效率 b. 评价两种疗法的R0手术切除率 c. 评价两种疗法的手术并发症发生率  

Objectives of Study:

Primary endpoint : to compare progress free survival(PFS ) between patients with L- HIPEC +NAC +D2 gastrectomy and patients with D2 gastrectomy alone in cT4- LAGC patients Secondary endpoints: 1. the overall survival (OS) and peritoneal metastasis rate (PMR) between L-HIPEC+NAC+D2 gatrectomy and D2 gastrectomy alone in cT4-LAGC patients; 2. to determine the rates of therapeutic toxicity and surgical complication in the two different treatment groups.  

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) 18岁≤年龄≤75岁 2) ECOG评分≤2分 3) 美国麻醉协会分类I-III 4) 组织病理学检查证实为胃腺癌,无原发灶或转移灶切除史 5) MDCT, 内镜超声或腹腔镜检查证实浆膜浸润(T4) 6) 良好的骨髓、肝肾功能,各项实验室检查指标如下: ? 血清嗜中性粒细胞≥1.5 x 10 2/L ? 血小板≥100 x 109/L ? 血清总胆红素≤正常值上限(ULN)的1.5倍,丙氨酸转氨酶与天冬氨酸转氨酶≤ULN的2.5倍,肌酐清除率≥50 ml/min 7) 育龄女性病人尿或血清妊娠试验阴性 8) 预计生存期≥3个月 9) 本人愿意提供血液标本供药代学研究 10)本人签署知情同意书 

Inclusion criteria

1. Age 18 years to 70 years; 2. World Health Organization (WHO)performance status 0 to 2; 3. American Society of Anesthesiologists classification I to III; 4. Biopsy proven adenocarcinoma of the stomach; 5. MDCTendoscopic ultrasound or laparoscopy proven serosal invasion (T4); 6. with P0/CY1 or P0/CY0; Adequate bone marrow, hepatic and renal function. Acceptable laboratory values at recruitment: Absolute neutrophil count greater than or equal to 1.5 x 10^2/L; Platelet count greater than or equal to 100 x 10^9/L; Serum bilirubin less than or equal to 1.5 times the upper limit of normal (ULN) and alanine transaminase and aspartate transaminase less than or equal to 2.5 ULN; Creatinine clearance greater than or equal to 50 ml/min (measured or calculated by Cockcroft-Gault formula); Negative pregnancy test (urine/serum) for female patients with childbearing potential; Life expectancy 3 months or greater; Able and willing to undergo blood sampling for pharmacokinetics; Written informed consent. 

排除标准:

1)出现远处转移(如:肝转移、肺转移、腹主动脉旁淋巴结等转移) 2)肉眼可见的腹膜转移、卵巢转移或出现恶性腹水 3)胃癌复发 4)原发胃癌已作切除 5)妊娠或哺乳期妇女;拒绝采取避孕措施的育龄患者(包括男性) 6)严重的未控制的反复感染者,或HIV感染者 7)B或C型肝炎伴病毒复制者 8)临床上严重的(即活动的)心脏病,6个月内发生心肌梗塞或不稳定性心绞痛 9)未控制的糖尿病 10)存在可能或肯定会干扰研究过程的医疗状况(包括随访与遵从性) 11)对化疗药物或有关药剂过敏 

Exclusion criteria:

1. Distant metastases (eg. Liver, lung metastasispara-aortic lymph node) and other distant metastasis; 2. Macroscopic peritoneal metastasis, ovarian metastasis or malignant ascites; 3. Recurrent gastric cancer; 4. Prior resection of the primary gastric cancer; 5. Pregnancy, breast feeding, active pregnancy ambition, or unreliable contraceptive methods; 6. Uncontrolled infectious disease or known infection with human immunodeficiency virus; 7. known history of hepatitis B or C with active viral replication; 8. Recent myocardial infarction (less than 6 months) or unstable angina; 9. Uncontrolled diabetes mellitus; 10. Any medical condition that is considered to possibly, probably, or definitely interfere with study procedures (including adequate follow-up and compliance) and/or would jeopardize safe treatment; 11. Known hypersensitivity for any of the applied chemotherapeutic agents and/or their solvents. 

研究实施时间:

Study execute time:

From2019-06-01To 2021-12-31 

征募观察对象时间:

Recruiting time:

From2019-06-01To 2021-05-31 

干预措施:

Interventions:

组别:

实验组

样本量:

163

Group:

Experimental Group

Sample size:

干预措施:

新辅助化疗(NAC)与经腔镜腹腔内温热化疗(L-HIPEC)联合R0胃癌根治术

干预措施代码:

Intervention:

Combined Neoadjuvant Chemotherapy (NAC) and Laparoscopic Intraperitoneal Hyperthermic Chemotherapy (L-HIPEC) Followed By R0 Gastrectomy

Intervention code:

组别:

对照组

样本量:

163

Group:

Control Group

Sample size:

干预措施:

R0胃癌根治术

干预措施代码:

Intervention:

R0 Gastrectomy

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海交通大学医学院附属瑞金医院 

单位级别:

三级甲等 

Institution
hospital:

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

无疾病进展生存

指标类型:

主要指标 

Outcome:

Progress free survival

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

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:

并发症率

指标类型:

次要指标 

Outcome:

Morbidity Rate

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:

腹腔灌洗夜

组织:

Sample Name:

Peritoneal Lavage

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:

尚未开始

Not yet 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):

完全随机化分组,通过统计分析软件生成随机分配表实现随机化,采用中央随机化进行随机分配,并完成分配隐藏。

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

Completely randomized grouping. Random distribution table is generated by statistical analysis software to achieve randomization. Central randomization is used for random distribution, and blind distribution will be completed.

盲法:

Open label

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):

原始数据公开时间:

The time of sharing IPD:

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):

2021年,本网站,中国临床试验注册中心; ResMan

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

Year 2021,this web site ,Chinese Clinical Trial Registry; 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:

 2019-07-16
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