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
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
- 手順：Biospecimen Collection
- 手順：Magnetic Resonance Imaging
- 他の：Questionnaire Administration
- 手順：Computed Tomography
- 放射線：F-18 Fluoroethyltyrosine
- 薬：Fluorodopa F 18
- 放射線：Dose-intensified Photon Beam Radiation Therapy
- 手順：Positron Emission Tomography
- 放射線：Proton Beam Radiation Therapy
- 放射線：Proton Beam Radiation Therapy
- 放射線：Proton Beam Radiation Therapy
- 放射線：Proton Beam Radiation Therapy
- 薬：Temozolomide
- 放射線：Standard Photon Beam Radiation Therapy
- 放射線：Dose-intensified Accelerated Photon Beam Radiation Therapy
- 放射線：Accelerated Photon Beam Radiation Therapy
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- フェーズ 3
連絡先と場所
研究場所
-
-
Arizona
-
Scottsdale、Arizona、アメリカ、85259
- Mayo Clinic in Arizona
-
主任研究者：
- Sujay A. Vora
-
コンタクト：
- Sujay A. Vora
- 電話番号：480-342-2000
- メール：vora.sujay@mayo.edu
-
-
Florida
-
Jacksonville、Florida、アメリカ、32224-9980
- Mayo Clinic in Florida
-
主任研究者：
- Daniel Trifiletti
-
コンタクト：
- Daniel Trifiletti
- 電話番号：904-953-2000
- メール：trifiletti.daniel@mayo.edu
-
-
Minnesota
-
Albert Lea、Minnesota、アメリカ、56007
- Mayo Clinic Health System in Albert Lea
-
コンタクト：
- John E. Yeakel
- 電話番号：507-668-2063
- メール：yeakel.john@mayo.edu
-
主任研究者：
- John E. Yeakel
-
Mankato、Minnesota、アメリカ、56001
- Mayo Clinic Health Systems-Mankato
-
コンタクト：
- Jason T. Hayes
- 電話番号：507-668-2063
- メール：hayes.jason@mayo.edu
-
主任研究者：
- Jason T. Hayes
-
Rochester、Minnesota、アメリカ、55905
- Mayo Clinic in Rochester
-
コンタクト：
- William Breen
- 電話番号：507-284-3261
-
主任研究者：
- William Breen
-
-
Wisconsin
-
Eau Claire、Wisconsin、アメリカ、54701
- Mayo Clinic Health System-Eau Claire Clinic
-
コンタクト：
- Now Bahar Alam
- 電話番号：715-464-8124
- メール：alam.nowbahar@mayo.edu
-
主任研究者：
- Now Bahar Alam
-
La Crosse、Wisconsin、アメリカ、54601
- Mayo Clinic Health System-Franciscan Healthcare
-
コンタクト：
- Abigail L. Stockham
- 電話番号：608-392-7332
- メール：stockham.abigail@mayo.edu
-
主任研究者：
- Abigail L. Stockham
-
-
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：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
他の名前：
Undergo MRI
他の名前：
Ancillary studies Undergo FET or FDOPA PET/CT
他の名前：
Given via injection
他の名前：
Given IV
他の名前：
Undergo dose-intensified photon radiation therapy
他の名前：
Undergo FET or FDOPA PET/CT
他の名前：
Undergo dose-intensified proton radiation therapy
他の名前：
Undergo standard proton radiation therapy
他の名前：
Undergo dose-intensified accelerated proton radiation therapy
他の名前：
Undergo accelerated proton radiation therapy
他の名前：
Given SOC temozolomide
他の名前：
|
|
アクティブコンパレータ：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
他の名前：
Undergo MRI
他の名前：
Ancillary studies Undergo FET or FDOPA PET/CT
他の名前：
Given via injection
他の名前：
Given IV
他の名前：
Undergo FET or FDOPA PET/CT
他の名前：
Undergo dose-intensified proton radiation therapy
他の名前：
Undergo standard proton radiation therapy
他の名前：
Undergo dose-intensified accelerated proton radiation therapy
他の名前：
Undergo accelerated proton radiation therapy
他の名前：
Given SOC temozolomide
他の名前：
Undergo standard photon radiation therapy
他の名前：
|
|
実験的：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
他の名前：
Undergo FET or FDOPA PET/CT
他の名前：
Given via injection
他の名前：
Given IV
他の名前：
Undergo FET or FDOPA PET/CT
他の名前：
Undergo dose-intensified proton radiation therapy
他の名前：
Undergo standard proton radiation therapy
他の名前：
Undergo dose-intensified accelerated proton radiation therapy
他の名前：
Undergo accelerated proton radiation therapy
他の名前：
Given SOC temozolomide
他の名前：
Undergo dose-intensified accelerated photon radiation therapy
他の名前：
|
|
アクティブコンパレータ：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
他の名前：
Undergo FET or FDOPA PET/CT
他の名前：
Given via injection
他の名前：
Given IV
他の名前：
Undergo FET or FDOPA PET/CT
他の名前：
Undergo dose-intensified proton radiation therapy
他の名前：
Undergo standard proton radiation therapy
他の名前：
Undergo dose-intensified accelerated proton radiation therapy
他の名前：
Undergo accelerated proton radiation therapy
他の名前：
Given SOC temozolomide
他の名前：
Undergo accelerated photon radiation therapy
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Overall survival (Cohort 1)
時間枠：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)
時間枠：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
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of grade 3+ central nervous system (CNS) toxicity, regardless of attribution (Overall CNS toxicity)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
|
その他の成果指標
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Neurocognitive outcomes (Cohort 1)
時間枠：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
|
協力者と研究者
捜査官
捜査官
- 主任研究者：William Breen、Mayo Clinic in Rochester
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
- 新生物
- 組織型別の新生物
- 新生物、腺および上皮
- 星細胞腫
- 神経膠腫
- 新生物、神経上皮
- 神経外胚葉性腫瘍
- 新生物、生殖細胞および胚
- 新生物、神経組織
- 膠芽腫
- 有機化学物質
- 複素環化化合物、1リング
- 複素環化化合物
- 調査手法
- 治療
- 臨床検査技術
- 診断技術と手順
- 診断
- アゾール
- 物理現象
- ダカルバジン
- トリアゼン
- イミダゾール
- 無機化学物質
- 要素
- 化学技術、分析
- スペクトル分析
- イオン
- 電解質
- 電磁現象
- 磁気現象
- 放射線療法
- 電磁放射
- ガス
- 基本粒子
- ライト
- 光学現象
- 放射線、非イオン化
- 重いイオン放射線療法
- 陽イオン、モノベリント
- 陽イオン
- 水素
- 核子
- テモゾロミド
- 放射線
- 標本処理
- 磁気共鳴分光法
- 光子
- Fluorodopa F 18
- 陽子療法
- 陽子
- （18F）フルオロエチルチロシン
その他の研究ID番号
その他の研究ID番号
- GMROR2661
- NCI-2026-07628 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
- 26-003443 (その他の識別子：Mayo Clinic Institutional Review Board)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。