Advanced Imaging-Guided Standard Versus Dose-Intensified Radiation Therapy for the Treatment of Newly Diagnosed Glioblastoma, SAGA 2.0 Trial
Stereotactic Advanced-Imaging Guided Radiotherapy for Glioblastoma (SAGA 2.0)
This clinical trial studies how well advanced imaging-guided standard dose versus (vs.) dose-intensified radiation therapy (RT) and dose-intensified accelerated RT works in treating patients with newly diagnosed glioblastoma. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. During dose-intensified RT, a higher dose than normal of radiation therapy is delivered over 6 weeks. During dose-intensified accelerated RT, the higher dose of radiation therapy is delivered over a shorter amount of time (2 weeks) than normal (6 weeks). Patients also undergo an advanced brain imaging positron emission tomography (PET)/computed tomography (CT) scan (using a radioactive drug called either FET or FDOPA) prior to RT to that may help doctors better plan the treatment. Dose-intensified and dose-intensified accelerated radiation therapy may be effective in treating patients with newly diagnosed glioblastoma. Giving dose-intensified RT or dose-intensified accelerated RT guided by advanced imaging may work better than standard dose RT in treating patients with newly diagnosed glioblastoma.
IND Numbers: 61300, 140882, 176402, 154793, 167879
研究概览
地位
干预/治疗
- 程序：Biospecimen Collection
- 程序：Magnetic Resonance Imaging
- 其他：Questionnaire Administration
- 程序：Computed Tomography
- 辐射：F-18 Fluoroethyltyrosine
- 药品：Fluorodopa F 18
- 辐射：Dose-intensified Photon Beam Radiation Therapy
- 程序：Positron Emission Tomography
- 辐射：Proton Beam Radiation Therapy
- 辐射：Proton Beam Radiation Therapy
- 辐射：Proton Beam Radiation Therapy
- 辐射：Proton Beam Radiation Therapy
- 药品：Temozolomide
- 辐射：Standard Photon Beam Radiation Therapy
- 辐射：Dose-intensified Accelerated Photon Beam Radiation Therapy
- 辐射：Accelerated Photon Beam Radiation Therapy
研究类型
注册 (估计的)
阶段
- 第三阶段
联系人和位置
学习地点
-
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Arizona
-
Scottsdale、Arizona、美国、85259
- Mayo Clinic in Arizona
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首席研究员：
- Sujay A. Vora
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接触：
- Sujay A. Vora
- 电话号码：480-342-2000
- 邮箱：vora.sujay@mayo.edu
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Florida
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Jacksonville、Florida、美国、32224-9980
- Mayo Clinic in Florida
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首席研究员：
- Daniel Trifiletti
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接触：
- Daniel Trifiletti
- 电话号码：904-953-2000
- 邮箱：trifiletti.daniel@mayo.edu
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Minnesota
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Albert Lea、Minnesota、美国、56007
- Mayo Clinic Health System in Albert Lea
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接触：
- John E. Yeakel
- 电话号码：507-668-2063
- 邮箱：yeakel.john@mayo.edu
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首席研究员：
- John E. Yeakel
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Mankato、Minnesota、美国、56001
- Mayo Clinic Health Systems-Mankato
-
接触：
- Jason T. Hayes
- 电话号码：507-668-2063
- 邮箱：hayes.jason@mayo.edu
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首席研究员：
- Jason T. Hayes
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Rochester、Minnesota、美国、55905
- Mayo Clinic in Rochester
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接触：
- William Breen
- 电话号码：507-284-3261
-
首席研究员：
- William Breen
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Wisconsin
-
Eau Claire、Wisconsin、美国、54701
- Mayo Clinic Health System-Eau Claire Clinic
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接触：
- Now Bahar Alam
- 电话号码：715-464-8124
- 邮箱：alam.nowbahar@mayo.edu
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首席研究员：
- Now Bahar Alam
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La Crosse、Wisconsin、美国、54601
- Mayo Clinic Health System-Franciscan Healthcare
-
接触：
- Abigail L. Stockham
- 电话号码：608-392-7332
- 邮箱：stockham.abigail@mayo.edu
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首席研究员：
- Abigail L. Stockham
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age ≥ 18 years
- Histological confirmation of glioblastoma (IDH-wildtype)
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 3 at baseline
- Provide written informed consent or have a Legally Authorized Representative (LAR) who is responsible for the care and well-being of the potential study participant, provide consent in accordance with ethical, regulatory, and institutional requirements
- Willing to return to enrolling institution for follow-up either in-person or by video visit (where indicated)
Exclusion Criteria:
- Known to be pregnant or nursing
- Unable to undergo MRI scans with contrast (such as patients with devices or metal in head that is MRI incompatible)
- Unable to undergo amino acid PET (FET or FDOPA) scan (such as allergy to the contrast/tracer, or technical or patient factors per the discretion of the treating physician)
- Prior radiation (including tile-based brachytherapy) or chemotherapy for glioblastoma (note: prior cancer diagnoses and treatment for other cancers are not exclusion criteria, and multiple surgeries prior to enrollment is not an exclusion criteria)
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 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：Arm A (dose-intensified radiation therapy)
Patients undergo thirty treatment fractions of dose-intensified proton or photon radiation therapy QD (Monday-Friday) over 6 weeks in the absence of disease progression or unacceptable toxicity. Patients may also receive SOC temozolomide during and/or after radiation therapy at the discretion of the treating team. Additionally, patients receive FET via injection or FDOPA IV and undergo PET/CT prior to treatment and optionally during treatment and follow-up. Patients also undergo MRI and blood sample collection throughout the study. |
Undergo blood sample collection
其他名称：
Undergo MRI
其他名称：
Ancillary studies Undergo FET or FDOPA PET/CT
其他名称：
Given via injection
其他名称：
Given IV
其他名称：
Undergo dose-intensified photon radiation therapy
其他名称：
Undergo FET or FDOPA PET/CT
其他名称：
Undergo dose-intensified proton radiation therapy
其他名称：
Undergo standard proton radiation therapy
其他名称：
Undergo dose-intensified accelerated proton radiation therapy
其他名称：
Undergo accelerated proton radiation therapy
其他名称：
Given SOC temozolomide
其他名称：
|
|
有源比较器：Arm B (standard radiation therapy)
Patients undergo thirty treatment fractions of standard proton or photon radiation therapy QD (Monday-Friday) over 6 weeks in the absence of disease progression or unacceptable toxicity. Patients may also receive SOC temozolomide during and/or after radiation therapy at the discretion of the treating team. Additionally, patients receive FET via injection or FDOPA IV and undergo PET/CT prior to treatment and optionally during treatment and follow-up. Patients also undergo MRI and blood sample collection throughout the study. |
Undergo blood sample collection
其他名称：
Undergo MRI
其他名称：
Ancillary studies Undergo FET or FDOPA PET/CT
其他名称：
Given via injection
其他名称：
Given IV
其他名称：
Undergo FET or FDOPA PET/CT
其他名称：
Undergo dose-intensified proton radiation therapy
其他名称：
Undergo standard proton radiation therapy
其他名称：
Undergo dose-intensified accelerated proton radiation therapy
其他名称：
Undergo accelerated proton radiation therapy
其他名称：
Given SOC temozolomide
其他名称：
Undergo standard photon radiation therapy
其他名称：
|
|
实验性的：Arm C (dose-intensified accelerated radiation therapy)
Patients undergo ten treatment fractions of dose-intensified accelerated proton or photon radiation therapy QD (Monday-Friday) over 2 weeks in the absence of disease progression or unacceptable toxicity. Patients may also receive SOC temozolomide during and/or after radiation therapy at the discretion of the treating team. Additionally, patients receive FET via injection or FDOPA IV and undergo PET/CT prior to treatment and optionally during treatment and follow-up. Patients also undergo MRI throughout the study. |
Undergo MRI
其他名称：
Undergo FET or FDOPA PET/CT
其他名称：
Given via injection
其他名称：
Given IV
其他名称：
Undergo FET or FDOPA PET/CT
其他名称：
Undergo dose-intensified proton radiation therapy
其他名称：
Undergo standard proton radiation therapy
其他名称：
Undergo dose-intensified accelerated proton radiation therapy
其他名称：
Undergo accelerated proton radiation therapy
其他名称：
Given SOC temozolomide
其他名称：
Undergo dose-intensified accelerated photon radiation therapy
其他名称：
|
|
有源比较器：Arm D (accelerated radiation therapy)
Patients undergo ten treatment fractions of accelerated proton or photon radiation therapy QD (Monday-Friday) over 2 weeks in the absence of unacceptable toxicity. Patients may also receive SOC temozolomide during and/or after radiation therapy at the discretion of the treating team. Additionally, patients receive FET via injection or FDOPA IV and undergo PET/CT prior to treatment and optionally during treatment and follow-up. Patients also undergo MRI throughout the study. |
Undergo MRI
其他名称：
Undergo FET or FDOPA PET/CT
其他名称：
Given via injection
其他名称：
Given IV
其他名称：
Undergo FET or FDOPA PET/CT
其他名称：
Undergo dose-intensified proton radiation therapy
其他名称：
Undergo standard proton radiation therapy
其他名称：
Undergo dose-intensified accelerated proton radiation therapy
其他名称：
Undergo accelerated proton radiation therapy
其他名称：
Given SOC temozolomide
其他名称：
Undergo accelerated photon radiation therapy
其他名称：
|
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 |
|---|---|---|
|
Overall survival (Cohort 1)
大体时间：Up to 18 months
|
Overall survival (OS) is defined as the time from registration until death due to any cause. Will be summarized by treatment arm using the difference in proportions test. |
Up to 18 months
|
|
Overall survival (Cohort 2)
大体时间：Up to 12 months
|
Overall survival (OS) is defined as the time from registration until death due to any cause. A Bayesian pick-the-winner design will be used to identify the more promising treatment arm based on 12-month overall survival. |
Up to 12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of grade 3+ central nervous system (CNS) toxicity, regardless of attribution (Overall CNS toxicity)
大体时间：Up to 36 months post-radiation therapy (RT)
|
CNS toxicities will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0. For each treatment arm, CNS toxicity will be summarized as: the number and proportion of patients experiencing at least one qualifying grade ≥ 3 CNS toxicity event. Between-arm comparisons will be performed descriptively. |
Up to 36 months post-radiation therapy (RT)
|
|
Incidence of grade 3+ higher CNS toxicity at least possibly attributable to radiation therapy (Treatment-related CNS toxicity)
大体时间：Up to 36 months post-RT
|
As assessed by the treating investigator. CNS toxicities will be graded according to CTCAE 5.0. Events classified as possibly, probably, or definitely related to radiation therapy will be included. For each treatment arm, CNS toxicity will be summarized as: the number and proportion of patients experiencing at least one qualifying grade ≥ 3 CNS toxicity event. |
Up to 36 months post-RT
|
|
Quality of life (Cohort 1) - EORTC QLQ-C30
大体时间：Up to 6 months post-RT
|
The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 is a 30-item questionnaire a questionnaire used to assess the quality of life of cancer patients. Twenty-eight questions are answered on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, and 4= very much), and two questions are answered on a scale of 1-7 (1= very poor and 7=excellent). Higher summary scores indicate better health related quality of life. |
Up to 6 months post-RT
|
|
Quality of life (Cohort 1) - EORTC QLQ-BN20
大体时间：Up to 6 months post-RT
|
The EORTC QLQ-BN20 is a 20-item questionnaire related to symptoms experienced by patients with brain cancer during the past week. Questions are answered on a scale of 1-4 where 1=not at all, 2=a little; 3-quite a bit; and 4=very much. Higher scores indicate greater severity of symptoms. |
Up to 6 months post-RT
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Neurocognitive outcomes (Cohort 1)
大体时间：Up to 1 month post-RT
|
As measured by Mayo Test Drive (MTD), a web-based platform for remote self-administered cognitive assessment. The primary comparison will be the between-arm difference in mean change over time (arm-by-time interaction). Higher or average composite scores indicate functioning consistent with healthy cognitive peers for participant's age, sex, and education. Significantly negative scores suggest performance drops in memory and processing. An MTD score is a screening and monitoring tool, not a medical diagnosis. Lower scores do not automatically indicate Alzheimer's or dementia; they can be influenced by other factors such as fatigue, high stress, medications, technical issues during the test, or mild age-related changes. |
Up to 1 month post-RT
|
合作者和调查者
赞助
调查人员
- 首席研究员：William Breen、Mayo Clinic in Rochester
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- GMROR2661
- NCI-2026-07628 (注册表标识符：CTRP (Clinical Trial Reporting Program))
- 26-003443 (其他标识符：Mayo Clinic Institutional Review Board)
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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