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임상시험 NCT05781321은(는) 교모세포종에 대해 진행중, 모집종료 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
메이요 클리닉Short Course Radiotherapy for the Treatment of Patients With Glioblastoma, SAGA Study
I. To demonstrate non-inferior 12-month overall survival (OS) of patients with GBM treated with dose escalated hypofractionated radiotherapy compared to standard of care.
SECONDARY OBJECTIVES:
I. To demonstrate the safety of short-course radiotherapy via physician-reported grade (G) 3+ toxicity.
II. To explore patient-reported outcomes to demonstrate favorable quality of life with short-course radiotherapy for GBM.
III. To analyze the impact of shortening the treatment duration on treatment related lymphopenia and absolute lymphocyte counts.
EXPLORATORY OBJECTIVES:
I. To determine the cost-effectiveness of the 5-fraction treatment regimen compared to standard of care.
II. To explore the impact on the immune system with the 5-fraction treatment regimen. Immune phenotyping will be assessed by Flow Cytometry and cytometry by flight (CyTOF).
III. To analyze series of cytokine levels over time. IV. To assess patterns of failure, specifically focusing on differences in volume delineation via Fluorodopa F 18 (FDOPA) and magnetic resonance imaging (MRI) and recurrences in-field versus (vs.) out of field.
V. To conduct a subgroup analysis for just patients =< 65 cc. VI. To conduct a subgroup analysis for just patients with and without tumor treating fields.
VII. To analyze patient demographic data compared to historical controls to determine whether the short-course treatment regimen improves access to underserved populations.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients undergo short course RT for 5-10 fractions over 1-2 weeks on study. Patients also receive temozolomide orally (PO) on days 1-5 every 28 days during radiation therapy. Starting one month post-radiation, patients continue temozolomide on days 1-5 every 28 days for up to 5 adjuvant cycles in the absence of disease progression or unacceptable toxicity.
ARM B: Patients undergo standard course RT for 15-30 fractions over 3-6 weeks on study. Patients also receive temozolomide PO daily (QD) concurrently with radiation therapy and for up to 6 adjuvant cycles in the absence of disease progression or unacceptable toxicity.
All patients undergo positron emission tomography/computed tomography (PET/CT) with 18-F-DOPA administered intravenously (IV) prior to RT on study, and undergo MRI prior to RT and throughout the trial. Patients may optionally undergo blood sample collection during screening and on the trial.
After completion of study treatment, patients are followed up every 2 months for the first year, every 3 months for the second year, and every 4 months for the third year. After 3 years, clinical outcomes are monitored at least once a year until 5 years after treatment.
Stereotactic Accelerated Radiotherapy in GlioblastomA (SAGA)
- GMROR2261
- NCI-2023-01559 (등록 식별자) (CTRP (Clinical Trial Reporting Program))
- GMROR2261 (기타 식별자) (Mayo Clinic Radiation Oncology)
- 22-006990 (기타 식별자) (Mayo Clinic Institutional Review Board)
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Arm A (short course RT) Patients undergo short course RT for 5-10 fractions over 1-2 weeks on study. Patients also receive temozolomide PO on days 1-5 every 28 days during radiation therapy. Starting one month post-radiation, patients continue temozolomide on days 1-5 every 28 days for up to 5 adjuvant cycles in the absence of disease progression or unacceptable toxicity. Patients undergo PET/CT with 18-F-DOPA administered IV prior to RT on study, and undergo MRI prior to RT and throughout the trial. Patients may optionally undergo blood sample collection during screening and on the trial. | 가속 저분할 방사선 치료 Undergo short course RT 컴퓨터 단층 촬영 Undergo CT simulation Fluorodopa F 18 Given IV 자기 공명 영상 Undergo MRI 양전자 방출 단층촬영 Undergo PET 삶의 질 평가 Ancillary studies 설문지 관리 Complete questionnaires 테모졸로마이드 Given PO 생체 시료 수집 Undergo blood sample collection |
활성 대조군Arm B (standard course RT) Patients undergo standard course RT for 15-30 fractions over 3-6 weeks on study. Patients also receive temozolomide PO QD concurrently with radiation therapy and for up to 6 adjuvant cycles in the absence of disease progression or unacceptable toxicity. Patients undergo PET/CT with 18-F-DOPA administered IV prior to RT on study, and undergo MRI prior to RT and throughout the trial. Patients may optionally undergo blood sample collection during screening and on the trial. | 컴퓨터 단층 촬영 Undergo CT simulation Fluorodopa F 18 Given IV 자기 공명 영상 Undergo MRI 양전자 방출 단층촬영 Undergo PET 삶의 질 평가 Ancillary studies 설문지 관리 Complete questionnaires 방사선 치료 Undergo standard course RT 테모졸로마이드 Given PO 생체 시료 수집 Undergo blood sample collection |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Proportion of patients alive [overall survival (OS)] at 12 months | OS is defined as the time from study registration to death due to any cause. | Up to 12 months after enrollment |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Proportion of patients whose radiation oncologist reported a grade 3+ toxicity | Pretreatment symptoms/conditions will be graded at enrollment by the radiation oncology team and updated at each evaluation. Adverse Events will be calculated using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. | 30-, 90-, and 180-days post-radiotherapy (RT) |
Quality of life: EORTC QLQ-C30 | Assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), a 30 item questionnaire used to assess quality of life in cancer patients. Questions are answered using a 4-point Likert scale where 1=not at all and 4=very much, except for two items which use a 7-point scale where 1=very poor and 7=excellent. Higher scores on the questions answered 1-4 indicate more severe symptoms and greater difficulty. Higher scores on the 1-7 scales indicate better overall health and quality of life. | From baseline up to 3 years |
Quality of life: EORTC QLQ-BN20 | Assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Brain Neoplasm (QLQ-BN20), which consists of 20 questions answered using a 4-point Likert scale where 1=not at all and 4=very much. Higher scores reflect more severe symptoms. | From baseline up to 3 years |
Lymphocyte count | Assessed by blood test, lymphocyte count will be compared between arms by change in count from pretreatment to end of RT. | From baseline up to 3 years |
- Age >= 18 years
- Histological and/or molecular confirmation of glioblastoma
- Eastern Oncology Group (ECOG) performance status (PS) =< 3
- Ability to complete questionnaire(s) by themselves or with assistance
- 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
- Willing to return to enrolling institution for follow-up either in-person or by video visit
- Postoperative/post-biopsy tumor plus surgical bed size =< 6 cm in maximum diameter. This measurement includes both the enhancing region identified via T1 MRI with contrast, as well as the surgical cavity
Unable to undergo MRI scans with contrast
Unable to undergo an 18F-DOPA-PET scan (e.g., Parkinson's Disease, taking carbidopa/levodopa and/or less than 48 hours from discontinuance)
Any of the following:
- Pregnant women
- Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception
Tumors with IDH mutation
Previous brain radiation therapy
Patients who will not receive any radiation treatment or who will receive radiation treatment elsewhere (Note: radiotherapy can be given on the trial at Mayo Clinic facilities in Rochester, Arizona, or Florida, as well as at the Mayo Clinic Health System sites). Temozolomide, however, can be provided by another institution
메이요 클리닉868개의 진행 중인 임상시험 탐색 가능Arizona
Florida
Minnesota
Wisconsin