中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2200066836
最近更新日期： Date of Last Refreshed on：	2023-07-17 21:39:08
注册时间： Date of Registration：	2022-12-19 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	碳离子联合光子射线对比光子射线治疗初诊高级别脑胶质瘤前瞻性Ⅲ期对照临床研究
Public title：	Prospective phase III controlled clinical study of carbon ion combined with photon beam radiation contrast photon beam radiation in the treatment of newly diagnosed high-grade glioma
注册题目简写：
English Acronym：
研究课题的正式科学名称：	碳离子联合光子射线对比光子射线治疗初诊高级别脑胶质瘤前瞻性Ⅲ期对照临床研究
Scientific title：	Prospective phase III controlled clinical study of carbon ion combined with photon beam radiation contrast photon beam radiation in the treatment of newly diagnosed high-grade glioma
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：	李小军	研究负责人：	李小军
Applicant：	Xiaojin Li	Study leader：	Xiaojun Li
申请注册联系人电话： Applicant telephone：	+86 131 5016 0200	研究负责人电话： Study leader's telephone：	+86 131 5016 0200
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：	anglwe@sina.com	研究负责人电子邮件： Study leader's E-mail：	anglwe@sina.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：	甘肃省武威市凉州区宣武街16号	研究负责人通讯地址：	甘肃省武威市凉州区宣武街16号
Applicant address：	16 Xuanwu Street, Liangzhou District, Wuwei, Gansu	Study leader's address：	16 Xuanwu Street, Liangzhou District, Wuwei, Gansu
申请注册联系人邮政编码： Applicant postcode：	733000	研究负责人邮政编码： Study leader's postcode：	733000
申请人所在单位：	武威肿瘤医院
Applicant's institution：	Gansu Wuwei Tumor Hospital
研究负责人所在单位：	武威肿瘤医院
Affiliation of the Leader：	Gansu Wuwei Tumor 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：	2022-伦理审查-48	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：	甘肃省武威肿瘤医院医学伦理委员会
Name of the ethic committee：	Medical Ethics Committee of Gansu Wuwei Tumor Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2022-10-27 00:00:00
伦理委员会联系人：	胡军国
Contact Name of the ethic committee：	Junguo Hu
伦理委员会联系地址：	甘肃省武威市凉州区宣武街16号
Contact Address of the ethic committee：	16 Xuanwu Street, Liangzhou District, Wuwei, Gansu
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 935 2268222	伦理委员会联系人邮箱： Contact email of the ethic committee：	546296334@qq.com

研究实施负责（组长）单位：

武威肿瘤医院

Primary sponsor：

Wuwei Tumor Hospital Heavy Ion Center

研究实施负责（组长）单位地址：

甘肃省武威市凉州区宣武街16号

Primary sponsor's address：

16 Xuanwu Street, Liangzhou District, Wuwei, Gansu

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	甘肃	市(区县)：	武威
Country：	China	Province：	Gansu	City：	Wuwei
单位(医院)：	武威肿瘤医院	具体地址：	甘肃省武威市凉州区宣武街16号
Institution hospital：	Heavy Ion Radiotherapy Department	Address：	16 Xuanwu Street, Liangzhou District, Wuwei, Gansu

经费或物资来源：

中央引导地方科技发展资金项目22ZY1QH001

Source(s) of funding：

The central government guides local science and technology development fund projects22ZY1QH001

研究疾病：

初诊胶质母细胞瘤

Target disease：

Newly-diagnosed glioblastoma

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：

比较标准剂量光子放疗、碳离子联合光子放疗治疗初诊高级别脑胶质瘤的疗效及毒副反应。

Objectives of Study：

To compare the efficacy and toxicity of standard dose photon radiotherapy and carbon ion combined with photon radiotherapy in the treatment of newly diagnosed high-grade glioma

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

1. Age >=14 years and <=80 years;
2. Indication: According to the criteria of the fifth edition of WHO Classification of Central nervous System Tumors published in 2021, the histological characteristics and molecular phenotypes were integrated. The molecular phenotypes were IDH wild-type glioma and IDH mutant WHO grade III and IV glioma. They mainly included: IDH wild-type low-grade glioma (grade 4 astrocytoma defined by the 2021 WHO classification); Anaplastic Astrocytoma, AA; Anaplastic Oligodendroglioma, AOG; Anaplastic Oligoastrocytoma, AOA; Glioblastoma Multiforme, GBM. Regardless of the degree of completeness of the procedure, that is, after total, subtotal, or partial resection, and after stereotactic or craniotomy biopsy;
3. No distant or intraspinal dissemination and metastasis; Single or two intracranial lesions may be covered by the same radiotherapy plan.;
4. The treatment before radiotherapy was as follows: Initial radiotherapy: no interventional, photodynamic or other tumor ablation was performed within 4 weeks before radiotherapy; The surgical wound has healed completely;
5. MRI and enhanced CT examination can be accepted, and no metal artifacts in CTV; 
6. No history of other malignant tumors (except cured skin cancer and stage 0 cervical cancer); 7. Liver function, renal function, and bone marrow function were basically normal (ALT and AST < 1.5 times of ULN, bilirubin < 1.5*ULN; Adult endogenous creatinine clearance rate 60ml/min or serum creatinine SCR<=140 μmoi /L, BU<=6.8mmol/L; Hemoglobin level >9 g/dL; White blood cell count >=3.0*10^9/L; Platelet count >=100*10^9/L;) ;
8. Good physical condition, i.e. ECOG (Eastern Oncology Collaborative Group) 0~2; There were no comorbidities such as severe pulmonary hypertension, cardiovascular disease, peripheral vascular disease, or severe chronic heart disease that might affect radiotherapy. Cardiac function grade 1;
9. Adequate major organ function according to the New York College of Cardiology Classification (NYHA);
10. Predicted survival (after treatment) >=6 months;
11. Prior to radiotherapy, the patient or his or her legal representative had signed informed consent.

排除标准：

1. 病理未证实的 WHO II-IV级脑胶质瘤； 2. 无法安静平躺30分钟的病人； 3. 复发肿瘤的再程治疗； 4. 已出现远处转移，或颅内散在或多发（>2）病灶； 5. 曾接受过头部常规光子/质子/碳离子放射治疗；、 6. 曾接受过颅内放射性粒子植入，带有金属假体植入物可能影响粒子放射治疗剂量； 7. 伴幽闭恐惧症、带心脏起搏器或金属假体植入物而无法接受MRI检查； 8. 可能受高能射线干扰正常功能的或可能影响放射靶区剂量的心脏起搏器或其他金属假体植入物； 9. 危及器官的剂量限值无法达到预设安全剂量限制； 10. 妊娠（经血清或者尿β-HCG检验证实）或者泌乳期间； 11. 六个月内体重减轻超过20%； 12. 艾滋病患者，包括曾接受抗逆转录病毒治疗；梅毒活动期； 13. 伴有使试验方案不能顺利进行的严重合并症，包括没有控制的全身的或合并疾病（肺功能不足，心血管，肺，肝，肾，糖尿病等），滥用药物或酒精依赖，成瘾和/或精神疾病； 14. 依从性差的患者，包括可能不能完成治疗计划，或不能接受规定的随访和检查； 15. 曾患有其他恶性肿瘤(已治愈之皮肤癌与0期子宫颈癌除外)； 16. 有放射治疗的禁忌症； 17. 在入组本试验之前30天内参加过其他药物临床试验； 18. 无民事行为能力或者限制民事行为能力； 19. 任何病史，据研究者判断可能干扰试验结果或增加患者风险； 20. 医师认为不适合参加该试验的任何情况，医师认定碳离子放疗无法使患者获益，或合并有其他可能影响碳离子治疗的疾患或其他因素。无法理解治疗目的或不愿/无法签署治疗同意书。

Exclusion criteria：

1. WHO II-IV grade glioma not confirmed by pathology; 2. Patients who cannot lie still for 30 minutes; 3. Further treatment of recurrent tumors; 4. Distant metastasis, or scattered or multiple (>2) intracranial lesions; 5. Received conventional photon/proton/carbon ion radiotherapy to the head; 6. Had undergone intracranial radioactive particle implantation, and implants with metal prostheses may affect the dose of particle radiotherapy; 7. With claustrophobia, pacemaker or metal prosthesis implant, unable to undergo MRI examination; 8. Cardiac pacemakers or other metal prosthesis implants that may be subject to interference with normal function by high-energy radiation or that may affect the dose to the radiation target; 9. The dose limit of organs at risk cannot reach the preset safe dose limit; 10. Pregnancy (confirmed by serum or urine β-hCG test) or lactation period; 11. Lose more than 20% of body weight within six months; 12. People living with AIDS, including those who have received antiretroviral therapy; Active stage of syphilis; 13. There are serious comorbidities that prevent the trial protocol from being carried out, including uncontrolled systemic or co-morbidities (pulmonary insufficiency, cardiovascular, pulmonary, hepatic, renal, diabetes, etc.), drug or alcohol abuse, addiction, and/or mental illness; 14. Patients with poor compliance, including the possibility of not completing the treatment plan or failing to receive prescribed follow-up and examinations; 15. History of other malignant tumors (except cured skin cancer and stage 0 cervical cancer); 16. There are contraindications to radiotherapy; 17. Participated in other drug clinical trials within 30 days prior to enrollment in this trial; 18. Having no or limited capacity for civil conduct; 19. Any medical history that, in the investigator's judgment, may interfere with the trial results or increase the patient's risk; 20. Any situation in which the physician did not consider it appropriate to participate in the trial, in which the physician determined that the patient would not benefit from carbon-ion radiotherapy, or in which there were other medical conditions or other factors that might affect carbon-ion therapy. Unable to understand the purpose of treatment or unwilling/unable to sign consent for treatment.

研究实施时间：

Study execute time：

从 From 2023-01-01 00:00:00至 To 2025-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2023-01-01 00:00:00 至 To 2027-12-31 00:00:00

干预措施：

Interventions：

组别：	对照组	样本量：	39
Group：	Control group	Sample size：	39
干预措施：	标准光子放疗 (60Gy)	干预措施代码：
Intervention：	Standard photon radiation (60Gy)	Intervention code：

组别：	研究组	样本量：	39
Group：	Study group	Sample size：	39
干预措施：	碳离子联合光子放疗	干预措施代码：
Intervention：	Carbon ion combined with photon radiotherapy	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	甘肃	市(区县)：	武威
Country：	China	Province：	Gansu	City：	Wuwei
单位(医院)：	武威肿瘤医院	单位级别：	三甲
Institution hospital：	Heavy Ion Radiotherapy Department	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	18个月总生存率	指标类型：	主要指标
Outcome：	Overall survival at 18 months	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	毒副作用	指标类型：	主要指标
Outcome：	Side-effect	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	无进展生存	指标类型：	次要指标
Outcome：	Progression-free 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：	客观缓解率	指标类型：	次要指标
Outcome：	Objective remission 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：

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	14	岁 years
最大 Max age	80	岁 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）：

由中国临床试验注册中心通过计算机软件获得随机数字序列

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

Random number sequence generated by computer software by ChiCTR

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：
Blinding：
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

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）：	ResMan; http: //www.wwzlz.com/2026年1月1日公开,采用网络平台http: //www.wwzlz.com
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	ResMan; The metadata and protocol will be shared on January 1 2026 on the website: http: //www.wwzlz.com
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：	采用excel文档数据库进行保存和管理
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Excel document as the repository will be used for management.
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：	2022-12-19 16:39:29