A Pilot Trial of Adjuvant Hypofractionated Stereotactic Radiosurgery for Intermediate-risk Meningioma (SRS-AIM)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Proportion of participants with reported adverse events
研究概览
简要总结
This clinical trial tests the safety and effectiveness of hypofractionated stereotactic radiosurgery for treating patients who have undergone surgical resection for grade II meningiomas or grade I meningiomas that have come back after a period of improvement (recurrent). Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Stereotactic radiosurgery is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Hypofractionated stereotactic radiosurgery may be safe, tolerable, and effective in treating patients with grade II or recurrent grade I meningiomas after surgical resection.
详细描述
PRIMARY OBJECTIVE:
I. To evaluate the safety of adjuvant hypofractionated stereotactic radiosurgery after gross total resection of intermediate risk meningioma.
SECONDARY OBJECTIVES:
I. To report the efficacy of adjuvant hypofractionated stereotactic radiosurgery in participants with intermediate risk meningioma.
II. To evaluate the 3-year overall survival rate of participants treated with adjuvant stereotactic radiosurgery.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >+ 18 years at time of study entry
- •Ability to understand and the willingness to sign a written informed consent document.
- •Histologic diagnosis of newly diagnosed World Health Organization (WHO) grade 2 or recurrent WHO grade 1 meningioma. With regard to recurrent WHO grade 1 meningioma, participants must present with radiographic evidence of recurrence, and have a histologic diagnosis of WHO grade 1 meningioma at the most recent resection.
- •* Note: For participants diagnosed outside of University of California San Francisco (UCSF), re-review of pathology at UCSF is strongly encouraged. Hematoxylin and eosin (H&E) slides will be reviewed by UCSF pathologists.
- •Participants must have undergone a gross-total surgical resection as deemed by their neurosurgeon (Simpson grade I-III resection), using all available information which can include post-operative MRI, of a meningioma within 180 days of enrollment.
- •Participants must have a pre-operative MRI.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Karnofsky score of 70 or higher)
- •Participants must have post-operative MRI indicating anatomy suitable for hypofractionated radiosurgery, as reviewed by the Radiation Oncology co-principal investigators (PIs).
排除标准
- •Concurrent participation in another clinical study with an investigational product unless it is an observational (non-interventional) study or the follow-up period of an interventional study.
- •Extensive multifocal (3 or more meningiomas) or metastatic disease.
- •Participants with tumors within 2mm of the optic apparatus or brainstem will be excluded.
- •Participants with another active primary malignancy or history of previous malignancy (except non-melanoma skin cancers, low and intermediate risk prostate cancers, and in situ cancers such as bladder, gastric, colon, cervical/dysplasia, or breast) are excluded unless a complete remission was achieved at least 2 years prior to study entry and no additional therapy is required or anticipated to be required during the study period.
- •Female participants who are pregnant.
- •Any underlying medical or psychiatric condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of participant safety or study results.
- •Participants with uncontrolled seizures, defined as greater than 3 disabling seizures per day while on anti-epileptic drugs.
- •Participants who have had previous intracranial radiotherapy overlapping with the area that would be targeted for stereotactic radiosurgery by this study.
研究组 & 干预措施
Hypofractionated Stereotactic Radiosurgery (SRS)
Participants undergo hypofractionated stereotactic radiosurgery over 15-30 minutes QD on days 1-5 in the absence of disease progression or unacceptable toxicity.
干预措施: Hypofractionated Stereotactic Radiosurgery (SRS) (Radiation)
Hypofractionated Stereotactic Radiosurgery (SRS)
Participants undergo hypofractionated stereotactic radiosurgery over 15-30 minutes QD on days 1-5 in the absence of disease progression or unacceptable toxicity.
干预措施: Magnetic Resonance Imaging (MRI) (Procedure)
Hypofractionated Stereotactic Radiosurgery (SRS)
Participants undergo hypofractionated stereotactic radiosurgery over 15-30 minutes QD on days 1-5 in the absence of disease progression or unacceptable toxicity.
干预措施: Computed Tomography (CT) (Procedure)
结局指标
主要结局
Proportion of participants with reported adverse events
时间窗: Up to 1 year
Adverse events will be classified and graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The proportion of CTCAE grade 3-5 toxicity within 1 year of radiation will be estimated along with the exact 90% confidence interval.
次要结局
- Mean score on the Comprehensive Score for Financial Toxicity-Functional Assessment of Chronic Illness Therapy (COST-FACIT) over time(Up to 3 months)
- Mean score Decision Regret Scale (DRS)(Up to 1 year)
- Mean score on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) 30 - Functional Domains over time(Up to 3 years)
- Median Local Freedom from recurrence (LFFR)(Up to 3 years)
- Median overall survival (OS)(Up to 3 years)
- Median Progression-Free Survival (PFS)(Up to 3 years)
- Mean score on the EORTC QLQ Brain Cancer Module (BN20) over time(Up to 3 years)
- Frequency of responses on the Brief Work and Transportation Survey(Up to 3 months)
- Mean score on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) 30 - Global Health Status over time(Up to 3 years)
- Mean score on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) 30 - Symptoms over time(Up to 3 years)