Adjuvant Hypofractionated Stereotactic Radiosurgery for Intermediate-risk Meningioma

Официальное название

A Pilot Trial of Adjuvant Hypofractionated Stereotactic Radiosurgery for Intermediate-risk Meningioma (SRS-AIM)

Обзор

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.

Подробное описание

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.

III. To report on the financial impact, quality of life, and treatment burden of participants who undergo adjuvant stereotactic radiosurgery.

EXPLORATORY OBJECTIVES:

I. To prospectively collect and assess a prognostic and predictive gene expression panel biomarker and deoxyribonucleic acid (DNA) methylation based genomic classification systems for meningioma.

II. To report the comparative dosimetry of adjuvant stereotactic radiosurgery as compared to simulated external beam plans generated based on the drawn planning target volumes.

OUTLINE:

Participants undergo hypofractionated stereotactic radiosurgery over 15-30 minutes once daily (QD) on days 1-5 in the absence of disease progression or unacceptable toxicity. Additionally, participants undergo magnetic resonance imaging (MRI) throughout the study and may undergo computed tomography (CT) as necessary.

After completion of study treatment, participants are followed up at months 3 and 6 and then at years 1, 2 and 3.

Вмешательства

• Лучевая терапия Hypofractionated Stereotactic Radiosurgery (SRS)
  Undergo Hypofractionated Stereotactic Radiosurgery
• Процедура Magnetic Resonance Imaging (MRI)
  Undergo MRI
• Процедура Computed Tomography (CT)
  Undergo CT imaging

Первичные конечные точки

• Proportion of participants with reported adverse events [Срок оценки: Up to 1 year]

Вторичные конечные точки (10)

• Median Local Freedom from recurrence (LFFR) [Срок оценки: Up to 3 years]
• Median Progression-Free Survival (PFS) [Срок оценки: Up to 3 years]
• Median overall survival (OS) [Срок оценки: Up to 3 years]
• Mean score on the Comprehensive Score for Financial Toxicity-Functional Assessment of Chronic Illness Therapy (COST-FACIT) over time [Срок оценки: Up to 3 months]
• Frequency of responses on the Brief Work and Transportation Survey [Срок оценки: Up to 3 months]
• Mean score Decision Regret Scale (DRS) [Срок оценки: Up to 1 year]
• Mean score on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) 30 - Global Health Status over time [Срок оценки: Up to 3 years]
• Mean score on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) 30 - Functional Domains over time [Срок оценки: 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 [Срок оценки: Up to 3 years]
• Mean score on the EORTC QLQ Brain Cancer Module (BN20) over time [Срок оценки: Up to 3 years]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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 favourable-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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of California, San Francisco — San Francisco

Идентификаторы

NCT: NCT06557512 · 24724 · NCI-2024-06542

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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