Single Fraction Stereotactic Radiosurgery Versus Fractionated SRS For Intact Brain Metastases

What is the Purpose of this Study?

This study focuses on people who are having stereotactic radiosurgery (SRS) to treat cancer that has spread to their brain. The purpose of the study is to determine whether a type of SRS radiation treatment called fractionated SRS (FSRS) completed over 3 treatments to the areas of cancer in the brain can delay the time until the cancer worsens or returns compared to the usual SRS given in 1 treatment. The usual approach for patients with cancer that has spread to the brain is SRS that delivers a high dose of radiation in a single treatment to the small areas of cancer in the brain. Both SRS and FSRS only deliver radiation to the small areas of cancer in the brain and minimizes dose to the surrounding normal brain tissue. FSRS could stabilize the patient’s cancer and delay the time until is returns or worsens compared to the usual treatment (SRS), but it could also cause side effects. Participants will be randomly assigned to 1 of 2 groups. One group will receive SRS that delivers a high dose of radiation in a single treatment; the other group will receive FSRS that delivers a high dose of radiation given over 3 treatments.

Eligibility

* 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

Inclusion Criteria:

* 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

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Where can I participate?

CS Cancer at Cedars-Sinai Medical Center : Shannon Cyhan

More about this Clinical Trial

What is the full name of this clinical trial?

NRG-BN013: Phase III Trial of Single Fraction Stereotactic Radiosurgery Versus Fractionated SRS For Intact Brain Metastases

Study Details

Disease Type/Condition

Brain and Nervous System

Principal Investigator

Shiao, Stephen

Co-Investigators

Amin Mirhadi, Behrooz Hakimian, Chirag Patil, Jeremy Rudnick, Jethro Hu, John Yu, Ray Chu

Age Group

Adult

Phase

III

IRB Number

STUDY00004600

ClinicalTrials.gov ID

NCT06500455

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

Name

Shannon Cyhan

Shannon.Cyhan@cshs.org