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胃癌D2根治术后辅助性SOX方案化疗联合同步放疗的多中心III期随机对照临床研究
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注册号:

Registration number:

ChiCTR-TRC-12002919 

最近更新日期:

Date of Last Refreshed on:

2016-01-01 

注册时间:

Date of Registration:

2012-12-11 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

胃癌D2根治术后辅助性SOX方案化疗联合同步放疗的多中心III期随机对照临床研究 

Public title:

A randomized phase III trial of concurrent chemoradiotherapy consisting of S-1 and oxaliplatin (SOX) in gastric cancer with radical D2 lymph node dissection 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

胃癌D2根治术后辅助性SOX方案化疗联合同步放疗的多中心III期随机对照临床研究 

Scientific title:

A randomized phase III trial of concurrent chemoradiotherapy consisting of S-1 and oxaliplatin (SOX) in gastric cancer with radical D2 lymph node dissection 

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:

王辛 

研究负责人:

毕锋 

Applicant:

Wang Xin 

Study leader:

Bi Feng 

申请注册联系人电话:

Applicant telephone:

+86 18980602291 

研究负责人电话:

Study leader's telephone:

+86 18980601771 

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:

wangxin77213@yahoo.com.cn 

研究负责人电子邮件:

Study leader's E-mail:

bifeng@medmail.com.cn 

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:

四川省成都市外南国学巷37号四川大学华西医院肿瘤中心腹部肿瘤科 

研究负责人通讯地址:

四川省成都市外南国学巷37号四川大学华西医院肿瘤中心腹部肿瘤科 

Applicant address:

37 Guoxuexiang, Chengdu, China 

Study leader's address:

37 Guoxuexiang, Chengdu, China 

申请注册联系人邮政编码:

Applicant postcode:

610041 

研究负责人邮政编码:

Study leader's postcode:

610041 

申请人所在单位:

四川大学华西医院 

Applicant's institution:

West China Hospital, Sichuan 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:

ChiECRCT-2013007 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

中国注册临床试验伦理审查委员会 

Name of the ethic committee:

China ethicscommittee of registering clinical trials 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-04-03 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

四川大学华西医院肿瘤中心腹部肿瘤科 

Primary sponsor:

Department of medical oncology, Cancer Center, West China Hospital, Sichuan University 

研究实施负责(组长)单位地址:

四川省成都市外南国学巷37号四川大学华西医院肿瘤中心腹部肿瘤科 

Primary sponsor's address:

37 Guoxuexiang, Chengdu, 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):

四川

市(区县):

成都

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

四川大学华西医院

具体地址:

四川省成都市外南国学巷37号四川大学华西医院肿瘤中心腹部肿瘤科

Institution
hospital:

West China Hospital, Sichuan University

Address:

37 Guoxuexiang, Chengdu, China

经费或物资来源:

自筹 

Source(s) of funding:

Self financed 

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:

胃癌D2根治术后是否需要给予放疗,一直是近年来的讨论焦点。我们设计本研究的目的是:比较SOX方案加或不加同步放疗在治疗D2根治术后胃癌患者的疗效方面的差别。 

Objectives of Study:

Whether does the radioterhapy should be delivered in completely resected gastric cancer with D2 lymph node dissection is still controversy. So the objective of this study is to compare the efficacy between regimen of SOX with and without the concurrent radiotherapy for patients with gastric cancer after completely resection with D2 lymph node dissection. 

药物成份或治疗方案详述:

S-1, 草酸铂 

Description for medicine or protocol of treatment in detail:

S-1, oxaliplatin 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

(1) 年龄:18岁-70岁; (2) 经病理学确诊的,并已经手术切除的胃癌患者; (3) 手术为根治性手术,达到R0切除,及D2淋巴结清扫(保留脏器)(淋巴结清扫数量应≥15枚); (4) 距离手术时间不超过3个月; (5) 根据2010年版UICC/AJCC分期标准,术后病理分期T分期≥T4a,N分期≥N0;且经全面检查未发现肿瘤转移或术后复发,即M分期为M0者; (6)ECOG PS评分:0-1分; (7)患者手术前或手术后未接受过放疗及全身化疗者; (8)主要器官功能正常,即符合下列表征: ①血常规检查标准需符合:HB ≥9g/dL, N ≥ 1.5×109/L,PLT≥ 100×109/L ②生化检查需符合以下标准:Crea和BIL ≤ 1.0倍正常值上限(ULN),ALT和AST≤ 2.5倍正常值上限(ULN)。 (9)育龄妇女必须在入组前7天进行妊娠试验(血清或尿液),且结果为阴性,并且愿意在试验期间和末次给药后8周采用适当的方法避孕。对于男性,应用手术绝育,或同意在试验期间或末次给药后8周采用适当的方法避孕。 (10)受试者自愿加入本研究,签署知情同意书,依从性好,配合随访。 

Inclusion criteria

1. Age from 18-75y; 2. Patient with postoperative gastric cancer and which was confirmed by positive pathological diagnosis; 3. R0 and D2 Radical Gastrectomy with organ preserved should be delivered (with organs reserves) (the numbers of dissected lymph nodes should be more than 15); 4. Within 3 mothes after operation; 5. Post-surgery stage >=T4a, N0-3, M0 according to 2010 edition UICC/AJCC staging; 6. ECOG: 0-1; 7. No radiotherapy or systematic chemotherapy was delivered before or after operation; 8.Function of main organs are normal: (1) The results of blood tests are normal (HB>=9g/l, N >=1.5*10^9/L, PLT>=100*10^9/l); (2) The results of Blood Biochemistry are normal: Crea, TB <=1.0 folders; ALT, AST<=2.5 folders; 9. Women of reproductive age must take pregnancy test (serum or urine)in the first seven days, and the result should be negative, and they should be willing to use appropriate methods for contraception during the trials and eight weeks after the treatment. Men should adopt operation sterilization or agree to use appropriate methods for contraception during the trials and eight weeks after the treatment; 10. Patients with good compliance and follow-up should participate in the trial voluntarily and should sign the informed agreement. 

排除标准:

(1)以往或同时患有其他恶性肿瘤,但是已治愈的皮肤基底细胞癌和宫颈原位癌除外; (2)怀孕或哺乳妇女; (3)有严重心血管疾病及不易控制的糖尿病患者; (4) 有精神障碍者; (5) 有严重感染者; (6)对S-1或草酸铂过敏者; (7)在治疗开始前4周内参加了另外的临床试验者。 

Exclusion criteria:

1. Patient who has had the malignant tumor at present or before, except for cured basal cell carcinoma of skin or Cervical carcinoma in situ; 2. Pregnant or lactation women; 3. Serious heart disease, uncontrolled Diabetic; 4. psycologic disease; 5. Seriously or uncontrolled infection; 6. Allergy to S-1 or oxaliplatin; 7. Participant in another trial in the initial 4 weeks. 

研究实施时间:

Study execute time:

From2012-12-01To 2015-11-30 

征募观察对象时间:

Recruiting time:

From2012-12-01To 2018-11-30 

干预措施:

Interventions:

组别:

同步放化疗组

样本量:

310

Group:

group of concurrent chemoradiotherapy

Sample size:

干预措施:

同步放化疗

干预措施代码:

Intervention:

concurrent chemoradiotherapy

Intervention code:

组别:

化疗组

样本量:

310

Group:

Group of chemotherapy

Sample size:

干预措施:

化疗

干预措施代码:

Intervention:

chemoradiotherapy

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):

四川大学华西医院 

单位级别:

三甲医院 

Institution
hospital:

West China Hospital, Sichuan University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

3年无病生存

指标类型:

主要指标 

Outcome:

3y-disese 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:

3年总生存

指标类型:

次要指标 

Outcome:

3y-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:

局部控制率

指标类型:

次要指标 

Outcome:

local control 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:

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 70 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):

分层随机

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

stratified random

盲法:

Blinding:

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):

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

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

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:

 2012-12-11
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