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正在招募II 期编号 NCT04684368

A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT

报名条件(概要)

  • 年龄:3 Years – 29 Years
  • 性别:不限
  • 健康志愿者:不接受

完整入排标准请以官方页面为准。

开展国家/地区

United States、Australia、Canada、New Zealand

药品与企业信息

Biospecimen Collection治疗操作

其他名称:Biological Sample Collection、Biospecimen Collected、Sample Collection、Specimen Collection

Undergo collection of CSF and blood samples

其他名称:Blastocarb、Carboplat、Carboplatin Hexal、Carboplatino、Carboplatinum、Carbosin

Given IV

Etoposide药物

其他名称:Demethyl Epipodophyllotoxin Ethylidine Glucoside、EPEG、Lastet、Toposar、Vepesid、VP 16

Given IV

Filgrastim生物制品

其他名称:Filgrastim Biosimilar Filgrastim-sndz、Filgrastim Biosimilar Tbo-filgrastim、Filgrastim XM02、Filgrastim-aafi、Filgrastim-ayow、Filgrastim-sndz

Given subcutaneously (SC) or IV

其他名称:Asta Z 4942、Asta Z-4942、Cyfos、Holoxan、Holoxane、Ifex

Given IV

Magnetic Resonance Imaging治疗操作

其他名称:Magnetic Resonance、Magnetic Resonance Imaging (MRI)、Magnetic resonance imaging (procedure)、Magnetic Resonance Imaging Scan、Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance、MR

Undergo MRI

Mesna药物

其他名称:2-Mercaptoethanesulfonate, Sodium Salt、Ausobronc、D-7093、Filesna、Mercaptoethane Sulfonate、Mercaptoethanesulfonate

Given IV or orally

Pegfilgrastim生物制品

其他名称:Cegfila、Dulastin、Dyrupeg、Filgrastim SD-01、filgrastim-SD/01、Fulphila

Given SC

研发企业

Children's Oncology Group研究网络

试验官方登记的主要申办方;研究机构申办时会显示相应机构名称。

生产企业

公开药品批准资料或正式说明书暂未提供明确的生产企业信息。

合作机构

  • National Cancer Institute (NCI)美国国立卫生研究院

研发企业与生产企业可能不是同一家。研究阶段药品可能尚未公布生产企业;生产企业仅取自美国上市原研药说明书所列企业(不含仿制药),不作推测;仅在其他国家上市的药品暂无法显示。

研究简介(原文)

This phase II trial studies the best approach to combine chemotherapy and radiation therapy (RT) based on the patient's response to induction chemotherapy in patients with non-germinomatous germ cell tumors (NGGCT) that have not spread to other parts of the brain or body (localized). This study has 2 goals: 1) optimizing radiation for patients who respond well to induction chemotherapy to diminish spinal cord relapses, 2) utilizing higher dose chemotherapy followed by conventional RT in patients who did not respond to induction chemotherapy. Chemotherapy drugs, such as carboplatin, etoposide, ifosfamide, and thiotepa, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays or high-energy protons to kill tumor cells and shrink tumors. Studies have shown that patients with newly-diagnosed localized NGGCT, whose disease responds well to chemotherapy before receiving radiation therapy, are more likely to be free of the disease for a longer time than are patients for whom the chemotherapy does not efficiently eliminate or reduce the size of the tumor. The purpose of this study is to see how well the tumors respond to induction chemotherapy to decide what treatment to give next. Some patients will be given RT to the spine and a portion of the brain. Others will be given high dose chemotherapy and a stem cell transplant before RT to the whole brain and spine. Giving treatment based on the response to induction chemotherapy may lower the side effects of radiation in some patients and adjust the therapy to a more efficient one for other patients with localized NGGCT.

适应症

Central Nervous System Nongerminomatous Germ Cell TumorChoriocarcinomaEmbryonal CarcinomaImmature TeratomaMalignant TeratomaMixed Germ Cell Tumor

主动联系研究团队

这项试验目前在中国大陆没有研究中心

这种情况下,直接发"入组咨询"往往会被回复"您所在地区没有中心"。更有效的做法是申请同情用药/扩展准入(由主治医生一同提出),或询问能否到最近的境外中心参加。下面已为您切换到对应的信件版本。

查看完整申请路径与成功率说明 →

研究中心联系方式

问自己是否符合条件、如何预筛

我的病情档案

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英文版(发给研究团队)

Dear Study Team,

I am a patient in China and I am interested in participating in your clinical trial:

Study Title: A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT
ClinicalTrials.gov Identifier: NCT04684368
Sponsor: Children's Oncology Group
Investigational product: Biospecimen Collection, Carboplatin, Etoposide, Filgrastim, Ifosfamide

About me:
- Age: (please fill in)
- Sex: (please fill in)
- Confirmed diagnosis and stage: (please fill in)
- Biomarkers / genetic testing: not available
- Prior and current treatments: (please fill in)
- Performance status (ECOG): not assessed
- Current location: China
- Travel ability: (please fill in)

Could you please let me know:
1. Whether I might be eligible for this study;
2. Which site would be closest and most practical for me, and whether remote pre-screening is possible;
3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening.

I can provide English translations of my medical records. Thank you very much for your time and help.

Kind regards,
(your name)
(your email / phone with country code)

中文对照(供您核对)

尊敬的研究团队:

我是一位来自中国的患者,希望咨询参加以下临床试验的可能:

研究名称:A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT
试验编号:NCT04684368
申办方:Children's Oncology Group
研究药物:Biospecimen Collection、Carboplatin、Etoposide、Filgrastim、Ifosfamide

我的基本情况:
- 年龄:(请填写)
- 性别:(请填写)
- 确诊疾病与分期:(请填写)
- 基因/标志物检测:暂无
- 既往及当前治疗:(请填写)
- 体能状态(ECOG):未评估
- 目前所在城市:中国
- 可前往范围:(请填写)

想请教三个问题:
1. 我是否可能符合本研究的入组标准?
2. 哪个中心对我最方便可行?能否远程预筛?
3. 预筛需要准备哪些资料(病历、病理、影像、近期化验)?

我可以提供英文翻译版病历。感谢您的时间与帮助。

顺祝安康
(您的姓名)
(您的邮箱/带国际区号的电话)
用邮件客户端发送给 AKPAMC.OncologyResearchSupport@providence.org

提示:请与主治医生一起发信——由医生署名的申请,回复率远高于患者单独发信。首封邮件不要附身份证号等敏感信息。研究团队通常在 3–10 个工作日内回复,两周无回音可礼貌追问一次。

下一步怎么做?

  1. 把本页信息带给您的主治医生,评估是否适合参加。
  2. 点击下方按钮打开官方注册页,查看研究中心联系方式。
  3. 直接联系研究团队咨询报名事宜(通常有中文同声翻译服务可协助沟通)。
在 ClinicalTrials.gov 查看官方页面