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A Pilot Study of Ultra-High Dose Rate (ConformalFLASH®), for Reirradiation of Carcinoma of the Head and Neck (C-FLASH-01)

2026年9月17日 更新者：IBA Proton Therapy, Inc.
This pilot study is designed to evaluate the feasibility of delivering ultra-high dose-rate conformal proton therapy (ConformalFLASH) in participants requiring re-irradiation for head and neck cancer who are not amenable to surgical resection. ConformalFLASH treatment planning and delivery workflows are comparable to those of conventional Stereotactic Body Radiation Therapy (SBRT), a standard approach for re-irradiation in this population.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

C-FLASH-01 is a pilot study evaluating the feasibility of delivering ultra-high dose-rate conformal proton therapy (ConformalFLASH) to participants requiring re-irradiation for head and neck cancer who are not amenable to surgical resection. Stereotactic Body Radiation Therapy (SBRT) re-irradiation is a standard approach that enables highly conformal dose delivery over a limited number of fractions. ConformalFLASH is an investigational approach that applies SBRT principles using proton therapy delivered at ultra-high dose rates (≥ 40 Gray Relative Biological Effectiveness (GyRBE)/second), with the potential to reduce normal tissue toxicity while maintaining tumor control. Participants will undergo treatment planning and delivery consistent with standard SBRT workflows. Treatment consists of five fractions (8 GyRBE per fraction) delivered over approximately 1.5 to 2 weeks. The primary objective is to assess the feasibility of delivering conformal proton SBRT at dose rates ≥ 40 GyRBE/second, along with evaluation of acute toxicity. Secondary objectives include assessment of treatment delivery accuracy, late toxicity, clinical outcomes, and patient-reported quality of life.

研究类型

介入性

注册 (估计的)

10

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 美国
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19104

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Patients must sign an informed consent document that indicates they are aware of the investigational nature of the treatment in this protocol as well as the potential risks and benefits
  2. Patients ≥ 18 years old
  3. Patients ineligible for or decline upfront surgical resection
  4. Histologically confirmed diagnosis of carcinoma of the head and neck
  5. Prior receipt of at least 45 GyRBE radiotherapy to the head and neck
  6. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 or evidence of similar in the electronic medical record
  7. Life expectancy of more than 12 weeks
  8. Ability to understand and the willingness to provide written informed consent and to follow the study procedures

Exclusion Criteria:

  1. Receipt of prior head and neck radiotherapy within the prior 6 months
  2. Surgical resection of the current disease in the head and neck
  3. More than 3 areas of disease requiring reirradiation
  4. Disease focus exceeding 6.5 cm in greatest dimension
  5. Presence of distant metastatic disease
  6. Involvement of any of the following structures: skin, carotid artery, or mandible
  7. Receipt of concurrent chemotherapy during radiotherapy
  8. Uncontrolled intercurrent illness including medical and psychiatric, and social situations that would limit compliance with study requirements
  9. Enrolled in any other investigational studies that involve administrations of another cancer therapeutic (such as surgery, chemotherapy, immunotherapy) during RT
  10. Pregnant and/or breastfeeding

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Treatment Arm
ConformalFLASH irradiation
辐射：ConformalFLASH irradiation
Subjects will be treated with SBRT (8 GyRBE x 5 fractions over 1.5-2 weeks), using pencil-beam scanning proton therapy, delivered at an average dose rate of ≥ 40 GyRBE/second, without chemotherapy.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
ConformalFLASH treatment delivery feasibility
大体时间：Through treatment completion (within 1 month after last fraction)
Delivery of ≥ 95% of the prescribed dose to ≥ 95% of the clinical target volume (CTV) at an average dose rate of ≥ 40 GyRBE/second
Through treatment completion (within 1 month after last fraction)
Acute toxicities
大体时间：Up to 3 months after treatment start
Incidence of acute toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 6.0
Up to 3 months after treatment start

次要结果测量

结果测量
措施说明
大体时间
ConformalFLASH treatment delivery accuracy
大体时间：Through treatment completion (within 1 month after last fraction)
Dose delivered to the clinical target volume (CTV) and organs at risk (OARs) as well as the average dose rate to the CTV
Through treatment completion (within 1 month after last fraction)
Late toxicities
大体时间：Beyond 3 months after start of treatment and up to 5 years
Incidence of late toxicity as assessed by CTCAE version 6.0
Beyond 3 months after start of treatment and up to 5 years
Local Control
大体时间：3 months and 1 year
Absence of tumor recurrence or progression at the primary radiated disease site following initiation of study treatment, as assessed by imaging, supplemented by clinical examination and with biopsy confirmation when indicated
3 months and 1 year
Regional control
大体时间：3 months and 1 year
Absence of tumor recurrence or progression in regional lymph nodes following initiation of study treatment, as assessed by imaging, supplemented by clinical examination and with biopsy confirmation when indicated
3 months and 1 year
Metastasis-free survival
大体时间：3 months and 1 year
Time from first treatment to the first occurrence of distant metastatic disease or death from any cause.
3 months and 1 year
Overall survival
大体时间：3 months and 1 year
Time from first treatment to death from any cause
3 months and 1 year
Patient-reported quality of life
大体时间：Up to 5 years

Effect of the treatment on patient-reported quality of life, using the University of Washington Quality of Life Questionnaire (UW-QOL).The UW-QOL consists of domains based upon discrete ordinal responses regarding their past 7 days. Scoring is scaled so that a score of 0 represents the worst possible response, and a score of 100 represents the best possible response. The UW-QOL comprises 12 single-question domains, each between 3 and 6 response options. These options are scaled evenly from 0 (worst) to 100 (best), according to the hierarchy of response. Each domain is scored individually, and an overall composite score can be derived.

In addition, patients are asked to choose up to 3 of these domains that they consider most important to them. The UW-QOL also includes 3 global questions, one about how patient feel relative to before they developed their cancer, one about their health-related QOL and one about their overall QOL.
Up to 5 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

IBA Proton Therapy, Inc.

合作者

University of Pennsylvania

调查人员

  • 首席研究员：Alexander Lin, MD、University of Pennsylvania

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年9月14日

初级完成 (估计的)

2027年12月1日

研究完成 (估计的)

2032年12月1日

研究注册日期

首次提交

2026年6月2日

首先提交符合 QC 标准的

2026年6月11日

首次发布 (实际的)

2026年6月12日

研究记录更新

最后更新发布 (实际的)

2026年9月18日

上次提交的符合 QC 标准的更新

2026年9月17日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • IBA-04-UP

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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