ChiCTR2200066836 版本V1.1 版本创建时间2023/05/07 23:52:36 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：

 ChiCTR2200066836 

最近更新日期：

Date of Last Refreshed on：

 2022-12-19 16:39:49 

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：

 +8613150160200

研究负责人电话：

Study leader's
telephone：

+8613150160200

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)：

 武威肿瘤医院

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：

甘肃省武威肿瘤医院重离子中心

研究负责人通讯地址：

甘肃省武威肿瘤医院重离子中心

Applicant address：

16 Xuanwu Street, Liangzhou District, Wuwei City, Gansu Province, China

Study leader's address：

甘肃省武威肿瘤医院重离子中心

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, China

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：

甘肃省武威肿瘤医院重离子中心

Primary sponsor's address：

Heavy Ion Radiotherapy Department, Wuwei Cancer Hospital＆Institute, Wuwei,Academy of Medical Sciences, Gansu,China.733000.

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

甘肃省

市(区县)：

武威市

Country：

China

Province：

Gansu

City：

Wuwei

单位(医院)：

武威肿瘤医院

具体地址：

甘肃省武威肿瘤医院重离子中心

Institution
hospital：

Heavy Ion Radiotherapy Department

Address：

Heavy Ion Radiotherapy Department, Wuwei Cancer Hospital＆Institute, Wuwei,Academy of Medical Sciences, Gansu,China.733000.

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：

1.年龄≥14岁且≤80岁；2.适应证：依据2021年发布的第5版《WHO中枢神经系统肿瘤分类》标准，整合组织学特征和分子表型，分子表型为IDH 野生型胶质瘤，IDH 突变型WHO Ⅲ、Ⅳ级胶质瘤。主要包括：IDH 野生型低级别胶质瘤（2021 版 WHO分类定义4级星形细胞瘤）；间变性星形细胞瘤Anaplastic Astrocytoma，AA；间变性少突细胞瘤Anaplastic Oligodendroglioma，AOG；间变性少突－星形细胞瘤Anaplastic Oligoastrocytoma，AOA；胶质母细胞瘤Glioblastoma Multiforme，GBM。不论手术完整程度，即全切、次全切或部分切除术后，以及立体定向或开颅活检术后。3.无远处或椎管内播散转移；颅内单个病灶，或两个病灶可被同一放射治疗计划覆盖。4.本次放疗前治疗情况如下：首程放疗：本次放疗前4周内，未接受介入、光动力或其他肿瘤消融治疗；手术伤口已完全愈合。5.可接受MRI与增强CT检查，且CTV内无金属伪影；6.没有其他恶性肿瘤病史(已治愈之皮肤癌与0期子宫颈癌除外)；7.肝功能、肾功能、骨髓功能基本正常(ALT及AST＜正常高值(ULN)的 1.5 倍、胆红素＜1.5×ULN；成人内生肌酐清除率60ml/min 或血清肌酐 SCR≤140μmoI/L，BUN≤6.8mmol/L；血红蛋白水平>9 g/dL;白细胞计数≥3.0*109/L;血小板计数≥100*109/L；）8.体力状况好，即ECOG（美国东部肿瘤协作组） 0~2；未伴有严重的肺动脉高压、心血管疾病、周围血管疾病、严重的慢性心脏病等可能影响放疗进行的合并症。心功能分级1。（根据美国纽约心脏病学会心功能分级（NYHA）9.具有足够的主要脏器功能；10.预计生存期（经治疗）≥6个月；11.放射治疗前，患者或其法定代表人已签署知情同意书。

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, BUN≤6.8mmol/L; Hemoglobin level >9 g/dL; White blood cell count ≥3.0*109/L; Platelet count ≥100*109/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 WHOII-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. Whoii-iv grade glioma not confirmed by pathology; 2. Patients who cannot lie still for 30 minutes; 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：

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：

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)：

 甘肃省 

市(区县)：

 武威市 

Country：

China

Province：

Gansu

City：

Wuwei

单位(医院)：

 武威肿瘤医院 

单位级别：

 三甲医院 

Institution
hospital：

Heavy Ion Radiotherapy Department

Level of the institution：

Top three hospitals

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）：

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）：

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