Phase II Study of Short Course Hypofractionated Proton Beam Therapy Incorporating 18F-DOPA-PET/MRI for Elderly Patients With Newly Diagnosed Glioblastoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This phase II trial studies how well fluorodopa F 18-positron emission tomography/magnetic resonance imaging scan (18F-DOPA-PET/MRI) works in imaging elderly patients with newly diagnosed grade IV malignant glioma or glioblastoma during planning for a short course of proton beam radiation therapy. 18F-DOPA is a chemical tracer that highlights certain cells during imaging. PET scan, is a metabolic imaging technique which takes advantage of how tumor cells take up nutrients differently than normal tissue. MRI scans are used to guide radiation therapy for most brain tumors. Hypofractionated proton beam therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Using 18FDOPA-PET scans along with MRI scans may be able to provide the radiation doctor with information on tumor tissue versus normal, healthy tissue and may help the doctor more accurately plan the radiation treatment.
详细描述
PRIMARY OBJECTIVE:
I. Compare overall survival at 12 months for grade IV glioma patients after radiation therapy targeting volumes designed with both 18F-DOPA-PET and conventional magnetic resonance (MR) image (or PET/computed tomography [CT]) information with historical controls.
SECONDARY OBJECTIVES:
I. Compare progression free survival at 12 months after radiation therapy targeting volumes designed with both 18F-DOPA-PET and conventional MR image information with historical controls.
II. Determine acute and late effect toxicity after hypofractionated proton beam radiotherapy treatment including areas of high 18F-DOPA-PET uptake (T/N > 2.0).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed newly diagnosed grade IV malignant glioma
- •Planned radiation treatments at Mayo Clinic Arizona or Mayo Clinic Rochester
- •Willing to sign release of information for any radiation and/or follow-up records
- •Provide informed written consent
- •Patients with estimated glomerular filtration rate (eGFR) >= 60 mg/min/1.72 m^2
- •Ability to complete questionnaire(s) by themselves or with assistance
- •Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2
排除标准
- •Patients diagnosed with grades I-III glioma
- •Currently on Avastin at time of treatment
- •Unable to undergo MRI scans with contrast (e.g. cardiac pacemaker, defibrillator, kidney failure)
- •Unable to undergo an 18F-DOPA-PET scan (e.g. Parkinson's disease, taking anti-dopaminergic, or dopamine agonist medication or less than 6 half-lives from discontinuance of dopamine agonists)
- •NOTE: Other potentially interfering drugs: amoxapine, amphetamine, benztropine, buproprion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, norephedrine, phentermine, phenylpropanolamine, selegiline, paroxetine, citalopram, and sertraline. If a patient is on any of these drugs, list which ones on the on-study form
- •Pregnant women, nursing women, or men or women of childbearing potential who are unwilling to employ adequate contraception.
- •NOTE: All women enrolled in this study will be age 65 or over, and at the determination of the principal investigator (PI), will not be of childbearing potential. If the radiology department requires a pregnancy test before administering the 18FDOPA injection, they may perform one per their standard of care
研究组 & 干预措施
Treatment (18F-DOPA, PET/MRI, PET/CT, temozolomide)
Patients receive 18F-DOPA IV and undergo PET/MRI or PET/CT imaging scan. Patients then receive proton beam radiotherapy over 5 or 10 consecutive days excluding weekend and standard of care temozolomide on days 1-7 or 1-14. Beginning cycles 2, patients receive standard of care temozolomide on days 1-5. Cycles with temozolomide repeat every 28 days for up to 7 cycles in the in the absence of disease progression or unacceptable toxicity.
干预措施: Computed Tomography (Procedure)
Treatment (18F-DOPA, PET/MRI, PET/CT, temozolomide)
Patients receive 18F-DOPA IV and undergo PET/MRI or PET/CT imaging scan. Patients then receive proton beam radiotherapy over 5 or 10 consecutive days excluding weekend and standard of care temozolomide on days 1-7 or 1-14. Beginning cycles 2, patients receive standard of care temozolomide on days 1-5. Cycles with temozolomide repeat every 28 days for up to 7 cycles in the in the absence of disease progression or unacceptable toxicity.
干预措施: Fluorodopa F 18 (Other)
Treatment (18F-DOPA, PET/MRI, PET/CT, temozolomide)
Patients receive 18F-DOPA IV and undergo PET/MRI or PET/CT imaging scan. Patients then receive proton beam radiotherapy over 5 or 10 consecutive days excluding weekend and standard of care temozolomide on days 1-7 or 1-14. Beginning cycles 2, patients receive standard of care temozolomide on days 1-5. Cycles with temozolomide repeat every 28 days for up to 7 cycles in the in the absence of disease progression or unacceptable toxicity.
干预措施: Magnetic Resonance Imaging (Procedure)
Treatment (18F-DOPA, PET/MRI, PET/CT, temozolomide)
Patients receive 18F-DOPA IV and undergo PET/MRI or PET/CT imaging scan. Patients then receive proton beam radiotherapy over 5 or 10 consecutive days excluding weekend and standard of care temozolomide on days 1-7 or 1-14. Beginning cycles 2, patients receive standard of care temozolomide on days 1-5. Cycles with temozolomide repeat every 28 days for up to 7 cycles in the in the absence of disease progression or unacceptable toxicity.
干预措施: Positron Emission Tomography (Procedure)
Treatment (18F-DOPA, PET/MRI, PET/CT, temozolomide)
Patients receive 18F-DOPA IV and undergo PET/MRI or PET/CT imaging scan. Patients then receive proton beam radiotherapy over 5 or 10 consecutive days excluding weekend and standard of care temozolomide on days 1-7 or 1-14. Beginning cycles 2, patients receive standard of care temozolomide on days 1-5. Cycles with temozolomide repeat every 28 days for up to 7 cycles in the in the absence of disease progression or unacceptable toxicity.
干预措施: Proton Beam Radiation Therapy (Radiation)
Treatment (18F-DOPA, PET/MRI, PET/CT, temozolomide)
Patients receive 18F-DOPA IV and undergo PET/MRI or PET/CT imaging scan. Patients then receive proton beam radiotherapy over 5 or 10 consecutive days excluding weekend and standard of care temozolomide on days 1-7 or 1-14. Beginning cycles 2, patients receive standard of care temozolomide on days 1-5. Cycles with temozolomide repeat every 28 days for up to 7 cycles in the in the absence of disease progression or unacceptable toxicity.
干预措施: Quality-of-Life Assessment (Other)
Treatment (18F-DOPA, PET/MRI, PET/CT, temozolomide)
Patients receive 18F-DOPA IV and undergo PET/MRI or PET/CT imaging scan. Patients then receive proton beam radiotherapy over 5 or 10 consecutive days excluding weekend and standard of care temozolomide on days 1-7 or 1-14. Beginning cycles 2, patients receive standard of care temozolomide on days 1-5. Cycles with temozolomide repeat every 28 days for up to 7 cycles in the in the absence of disease progression or unacceptable toxicity.
干预措施: Questionnaire Administration (Other)
Treatment (18F-DOPA, PET/MRI, PET/CT, temozolomide)
Patients receive 18F-DOPA IV and undergo PET/MRI or PET/CT imaging scan. Patients then receive proton beam radiotherapy over 5 or 10 consecutive days excluding weekend and standard of care temozolomide on days 1-7 or 1-14. Beginning cycles 2, patients receive standard of care temozolomide on days 1-5. Cycles with temozolomide repeat every 28 days for up to 7 cycles in the in the absence of disease progression or unacceptable toxicity.
干预措施: Temozolomide (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Time from registration to death due to any cause, assessed up to 12 months
The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated utilizing exact binomial methodology. The distribution of survival time will be estimated using the method of Kaplan-Meier (1958).
次要结局
- Incidence of Adverse Events (AEs)(Up to 4 years)
- Progression Free Survival(Up to 4 years)