Testing Longer Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With Cancer That Has Spread to the Brain

Официальное название

Phase III Trial of Single Fraction Stereotactic Radiosurgery (SRS) Versus Fractionated SRS (FSRS) for Intact Brain Metastases

Обзор

This phase III trial compares the effectiveness of fractionated stereotactic radiosurgery (FSRS) to usual care stereotactic radiosurgery (SRS) in treating patients with cancer that has spread from where it first started to the brain. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. FSRS delivers a high dose of radiation to the tumor over 3 treatments. SRS is a type of external radiation therapy that uses special equipment to position the patient and precisely give a single large dose of radiation to a tumor. FSRS may be more effective compared to SRS in treating patients with cancer that has spread to the brain.

Подробное описание

PRIMARY OBJECTIVE:

I. To determine if the time to local failure is improved with FSRS compared to SRS in patients with intact (i.e., unresected) brain metastases.

SECONDARY OBJECTIVES:

I. To compare time to intracranial progression-free survival between FSRS and SRS.

II. To compare overall survival between FSRS and SRS. III. To determine if the time to local failure is improved with FSRS compared to SRS, as evaluated by central review of imaging.

IV. To evaluate if there is any difference in central nervous system (CNS) failure patterns (local versus \[vs.\] distant brain failure vs. both) in patients who receive FSRS compared to patients who receive SRS.

V. To compare the rates of radiation necrosis in patients who receive FSRS vs. SRS.

VI. To compare the time to salvage whole brain radiation therapy (WBRT) between patients who receive FSRS and those who receive SRS.

VII. To compare the rates of post-treatment adverse events associated with FSRS and SRS.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo SRS over 30-90 minutes for 1 fraction on study. Additionally, patients undergo computed tomography (CT) and magnetic resonance imaging (MRI) on study.

ARM II: Patients undergo FSRS over 30-90 minutes for 3 fractions on study. Additionally, patients undergo CT and MRI on study.

After completion of study treatment, patients are followed up every 3 months for 1 year, every 4 months for 1 year then every 6 months for 3 years.

Вмешательства

• Процедура Computed Tomography
  Undergo CT
• Лучевая терапия Fractionated Stereotactic Radiation Therapy
  Undergo FSRS
• Процедура Magnetic Resonance Imaging
  Undergo MRI
• Лучевая терапия Stereotactic Radiosurgery
  Undergo SRS

Первичные конечные точки

• Time to local failure [Срок оценки: From randomization (with the treatment planning magnetic resonance imaging as the 'baseline' for purposes of disease assessment) to local tumor progression of any study lesion(s), assessed up to 5 years]

Вторичные конечные точки (5)

• Intracranial progression-free survival (IPFS) [Срок оценки: From the date of randomization until intracranial progression (local or distant intracranial) or death from any cause, whichever occurs first, assessed up to 5 years]
• Overall survival [Срок оценки: From the date of randomization until death from any cause, assessed up to 5 years]
• Time to radiation necrosis (TTRN) [Срок оценки: From randomization until radiation necrosis, assessed up to 5 years]
• Time to whole brain radiation therapy (WBRT) [Срок оценки: Up to 5 years]
• Incidence of adverse events (AEs) [Срок оценки: Up to 2 years from start of radiation treatment]

Критерии участия

Критерии включения

• Pathologically (histologically or cytologically) proven diagnosis of one of the following solid tumor malignancies within 5 years prior to registration:

• Non-small cell lung cancer
• Melanoma
• Breast cancer
• Renal cell carcinoma
• Gastrointestinal cancer
• If the original histologic proof of malignancy is greater than 5 years, then more recent pathologic confirmation (e.g., from a systemic site or brain metastasis) or unequivocal imaging confirmation of extracranial metastatic disease (e.g. CT of the chest/abdomen/pelvis, positron emission tomography \[PET\]/CT, etc.) is required
• Patients must have at least 1 and up to 8 total intact brain metastases detected on a contrast-enhanced MRI performed ≤ 21 days prior to registration
• At least 1 of the up to 8 lesions must be a study eligible lesion, defined as lesion with a maximum diameter as measured on any orthogonal plane (axial, sagittal, coronal) of ≥ 1.0 cm and ≤ 3.0 cm
• All brain metastases must be located outside of the brainstem and ≥ 5 mm from the optic nerves or optic chiasm and ≤ 3.0 cm in maximum dimension

• Note: brainstem metastases per the MRI within 21 days of registration are an exclusion criterion; however, if the MRI used for treatment planning performed within 7 days of SRS/FSRS reveals a brainstem metastasis, the patient remains eligible if the patient is considered an appropriate radiosurgery candidate per the local investigator
• Patients must have a diagnosis-specific graded prognostic assessment ≥ 1.5
• No more than 2 lesions planned for resection if clinically indicated
• No known leptomeningeal disease (LMD)

• Note: For the purposes of exclusion, LMD is a clinical diagnosis, defined as positive cerebrospinal fluid (CSF) cytology and/or unequivocal radiologic or clinical evidence of leptomeningeal involvement. Patients with leptomeningeal symptoms in the setting of leptomeningeal enhancement by imaging (MRI) would be considered to have LMD even in the absence of positive CSF cytology. In contrast, an asymptomatic or minimally symptomatic patient with mild or nonspecific leptomeningeal enhancement (MRI) would not be considered to have LMD. In that patient, CSF sampling is not required to formally exclude LMD, but can be performed at the investigator's discretion based on level of clinical suspicion
• Age ≥ 18 years
• Karnofsky performance status (KPS) ≥ 60
• Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal
• No prior radiotherapy to the brain (partial or whole brain irradiation, SRS, FSRS, or prophylactic cranial irradiation \[PCI\])
• New York Heart Association Functional Classification II or better (NYHA Functional Classification III/IV are not eligible) (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification)
• No active infection currently requiring intravenous (IV) antibiotic management
• No hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
• No chronic obstructive pulmonary disease exacerbation or other acute respiratory illness precluding study therapy

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 262 центра

• Banner University Medical Center - Tucson — Tucson
• University of Arizona Cancer Center-North Campus — Tucson
• Mercy Hospital Fort Smith — Fort Smith
• University of Arkansas for Medical Sciences — Little Rock
• Kaiser Permanente-Anaheim — Anaheim
• Kaiser Permanente-Bellflower — Bellflower
• City of Hope Corona — Corona
• City of Hope Comprehensive Cancer Center — Duarte
• … и ещё 254 центра

Ирландия · 5 центров

Список центров уточняется — проверьте первичный протокол.

Канада · 2 центра

Список центров уточняется — проверьте первичный протокол.

Гонконг · 1 центр

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Идентификаторы

NCT: NCT06500455 · NRG-BN013 · NCI-2024-04812 · NRG-BN013 · NRG-BN013 · U10CA180868

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗