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
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
- 절차: Biospecimen Collection
- 절차: Magnetic Resonance Imaging
- 다른: Questionnaire Administration
- 절차: Computed Tomography
- 방사능: F-18 Fluoroethyltyrosine
- 의약품: Fluorodopa F 18
- 방사능: Dose-intensified Photon Beam Radiation Therapy
- 절차: Positron Emission Tomography
- 방사능: Proton Beam Radiation Therapy
- 방사능: Proton Beam Radiation Therapy
- 방사능: Proton Beam Radiation Therapy
- 방사능: Proton Beam Radiation Therapy
- 의약품: Temozolomide
- 방사능: Standard Photon Beam Radiation Therapy
- 방사능: Dose-intensified Accelerated Photon Beam Radiation Therapy
- 방사능: Accelerated Photon Beam Radiation Therapy
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 3단계
연락처 및 위치
연구 장소
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Arizona
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Scottsdale, Arizona, 미국, 85259
- Mayo Clinic in Arizona
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수석 연구원:
- Sujay A. Vora
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연락하다:
- Sujay A. Vora
- 전화번호: 480-342-2000
- 이메일: vora.sujay@mayo.edu
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Florida
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Jacksonville, Florida, 미국, 32224-9980
- Mayo Clinic in Florida
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수석 연구원:
- Daniel Trifiletti
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연락하다:
- Daniel Trifiletti
- 전화번호: 904-953-2000
- 이메일: trifiletti.daniel@mayo.edu
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Minnesota
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Albert Lea, Minnesota, 미국, 56007
- Mayo Clinic Health System in Albert Lea
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연락하다:
- John E. Yeakel
- 전화번호: 507-668-2063
- 이메일: yeakel.john@mayo.edu
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수석 연구원:
- John E. Yeakel
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Mankato, Minnesota, 미국, 56001
- Mayo Clinic Health Systems-Mankato
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연락하다:
- Jason T. Hayes
- 전화번호: 507-668-2063
- 이메일: hayes.jason@mayo.edu
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수석 연구원:
- Jason T. Hayes
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Rochester, Minnesota, 미국, 55905
- Mayo Clinic in Rochester
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연락하다:
- William Breen
- 전화번호: 507-284-3261
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수석 연구원:
- William Breen
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Wisconsin
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Eau Claire, Wisconsin, 미국, 54701
- Mayo Clinic Health System-Eau Claire Clinic
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연락하다:
- Now Bahar Alam
- 전화번호: 715-464-8124
- 이메일: alam.nowbahar@mayo.edu
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수석 연구원:
- Now Bahar Alam
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La Crosse, Wisconsin, 미국, 54601
- Mayo Clinic Health System-Franciscan Healthcare
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연락하다:
- Abigail L. Stockham
- 전화번호: 608-392-7332
- 이메일: stockham.abigail@mayo.edu
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수석 연구원:
- Abigail L. Stockham
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: 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
다른 이름들:
Undergo MRI
다른 이름들:
Ancillary studies Undergo FET or FDOPA PET/CT
다른 이름들:
Given via injection
다른 이름들:
Given IV
다른 이름들:
Undergo dose-intensified photon radiation therapy
다른 이름들:
Undergo FET or FDOPA PET/CT
다른 이름들:
Undergo dose-intensified proton radiation therapy
다른 이름들:
Undergo standard proton radiation therapy
다른 이름들:
Undergo dose-intensified accelerated proton radiation therapy
다른 이름들:
Undergo accelerated proton radiation therapy
다른 이름들:
Given SOC temozolomide
다른 이름들:
|
|
활성 비교기: 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
다른 이름들:
Undergo MRI
다른 이름들:
Ancillary studies Undergo FET or FDOPA PET/CT
다른 이름들:
Given via injection
다른 이름들:
Given IV
다른 이름들:
Undergo FET or FDOPA PET/CT
다른 이름들:
Undergo dose-intensified proton radiation therapy
다른 이름들:
Undergo standard proton radiation therapy
다른 이름들:
Undergo dose-intensified accelerated proton radiation therapy
다른 이름들:
Undergo accelerated proton radiation therapy
다른 이름들:
Given SOC temozolomide
다른 이름들:
Undergo standard photon radiation therapy
다른 이름들:
|
|
실험적: 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
다른 이름들:
Undergo FET or FDOPA PET/CT
다른 이름들:
Given via injection
다른 이름들:
Given IV
다른 이름들:
Undergo FET or FDOPA PET/CT
다른 이름들:
Undergo dose-intensified proton radiation therapy
다른 이름들:
Undergo standard proton radiation therapy
다른 이름들:
Undergo dose-intensified accelerated proton radiation therapy
다른 이름들:
Undergo accelerated proton radiation therapy
다른 이름들:
Given SOC temozolomide
다른 이름들:
Undergo dose-intensified accelerated photon radiation therapy
다른 이름들:
|
|
활성 비교기: 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
다른 이름들:
Undergo FET or FDOPA PET/CT
다른 이름들:
Given via injection
다른 이름들:
Given IV
다른 이름들:
Undergo FET or FDOPA PET/CT
다른 이름들:
Undergo dose-intensified proton radiation therapy
다른 이름들:
Undergo standard proton radiation therapy
다른 이름들:
Undergo dose-intensified accelerated proton radiation therapy
다른 이름들:
Undergo accelerated proton radiation therapy
다른 이름들:
Given SOC temozolomide
다른 이름들:
Undergo accelerated photon radiation therapy
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Overall survival (Cohort 1)
기간: 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)
기간: 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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Incidence of grade 3+ central nervous system (CNS) toxicity, regardless of attribution (Overall CNS toxicity)
기간: 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)
기간: 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
기간: 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
기간: 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
|
기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Neurocognitive outcomes (Cohort 1)
기간: 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
|
공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: William Breen, Mayo Clinic in Rochester
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
- 신생물
- 조직학적 유형에 따른 신생물
- 신생물, 선상 및 상피
- 성상세포종
- 신경교종
- 신생물, 신경상피
- 신경외배엽 종양
- 신생물, 생식 세포 및 배아
- 신생물, 신경 조직
- 교모세포종
- 유기 화학 물질
- 이종 사이 클릭 화합물, 1- 링
- 이종 사이 클릭 화합물
- 조사 기술
- 치료학
- 임상 실험실 기술
- 진단 기술 및 절차
- 진단
- Azoles
- 물리적 현상
- 다 카르 바진
- 트리아 젠
- 이미 다졸
- 무기 화학 물질
- 강요
- 화학 기술, 분석
- 스펙트럼 분석
- 이온
- 전해질
- 전자기 현상
- 자기 현상
- 방사선 요법
- 전자기 방사선
- 가스
- 기본 입자
- 빛
- 광학 현상
- 방사선, 비 이온화
- 무거운 이온 방사선 요법
- 양이온, 1가
- 양이온
- 수소
- 핵
- 테모졸로마이드
- 방사
- 시편 처리
- 자기 공명 분광법
- 광자
- Fluorodopa f 18
- 양성자 요법
- 양성자
- (18F) 플루오로 에틸 타티 로신
기타 연구 ID 번호
기타 연구 ID 번호
- GMROR2661
- NCI-2026-07628 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
- 26-003443 (기타 식별자: Mayo Clinic Institutional Review Board)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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