A RANDOMIZED PHASE III TRIAL OF PRE-OPERATIVE COMPARED TO POST-OPERATIVE STEREOTACTIC RADIOSURGERY IN PATIENTS WITH RESECTABLE BRAIN METASTASES

Cancer Categories

Brain and Nervous System

Karmanos Trial ID

NRG-BN012

NCT ID

NCT05438212

Age Group

Adult

Scope

National

Phase

Phase III

Principal Investigator

Michael
Dominello, D.O.
Oncology - Radiation View Profile

Objective:

Primary Objective:

To determine if the time to composite adverse endpoint (CAE) [defined as: 1)
local tumor progression within the surgical bed; and/or 2) adverse radiation effect
(ARE), the imaging correlate of post-SRS radiation necrosis; and/or 3) nodular
meningeal disease (nMD)] is improved in patients treated with pre-resection SRS
to the intact lesion versus those treated with post-resection SRS.

Secondary Objectives:

To assess the trajectory of symptom burden in patients treated with preresection SRS to the intact lesion versus those treated to the post-resection
surgical cavity as measured by MD Anderson Symptom Inventory for brain tumor
(MDASI-BT)
To determine whether there is improved overall survival (OS) in patients with
resected brain metastases who undergo pre-resection SRS compared to patients
who receive post-resection SRS.
To compare rates of ARE, the imaging correlate of radiation necrosis, in patients
who receive pre-resection SRS to patients who receive post-resection SRS.
To determine whether there is increased time to whole brain radiotherapy (WBRT)
in patients who receive pre-resection SRS compared to patients who receive postresection SRS.
To assess the trajectory of neuro-cognitive function in patients treated with preresection SRS to the intact lesion versus those treated to the post-resection
surgical cavity as measured by the Montreal Cognitive Assessment (MoCA).
To compare rates of nodular meningeal disease in patients who receive preresection SRS to patients who receive post-resection SRS.
To compare rates of local recurrence in the resection cavity for patients who
receive pre-resection SRS to patients who receive post-resection SRS.
To compare rates of local recurrence of intact, non-index metastases treated with SRS.
To compare rates of distant brain failure in patients who receive pre-resection
SRS to patients who receive post-resection SRS.
To assess toxicity in the two treatment arms.

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Eligibility

Inclusion Criteria:

Radiographic confirmation of 1-4 brain metastases, one of which requires resection, as defined by magnetic resonance imaging (MRI) with contrast obtained within 14 days prior to registration

The maximum diameter of the lesion to be resected on the post-contrast MRI, as measured on any orthogonal plane (axial, sagittal, coronal), must measure > 2.0 cm and < 5.0 cm.
The maximum diameter of the lesions not to be resected must measure < 4.0 cm

Known active or history of invasive non-central nervous system (CNS) primary cancer based on documented pathologic diagnosis within the past 3 years
All brain metastases must be located > 5 mm from the optic chiasm and outside the brainstem
Patient is able to medically tolerate surgery and SRS
The lesion chosen for surgical therapy must be deemed an appropriate target for safe, gross total resection by the treating surgeon
History/physical examination within 14 days prior to registration
Age >= 18
Karnofsky performance status (KPS) >= 60 within 14 days prior to registration
A 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 for at least 12 consecutive months
Participants who are sexually active must agree to use medically acceptable forms of contraception during treatment on this study to prevent pregnancy
The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information

Exclusion Criteria:

Prior cranial radiotherapy, including whole brain radiotherapy, or SRS to the resection site

Note: The index lesion to be resected cannot have been previously treated with SRS (i.e. repeat radiosurgery to the same location/lesion is not allowed on this protocol). Previous SRS to other lesions is allowed

Evidence of 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

Any medical conditions which would make this protocol unreasonably hazardous, including, but not limited to: contraindications to general endotracheal anesthesia; intracranial surgery; and stereotactic radiosurgery
Primary histology of germ cell tumor, small cell carcinoma or lymphoma
More than one brain metastasis planned for resection
Inability to undergo MRI with contrast
Planned administration of cytotoxic chemotherapy or tyrosine/multi-kinase inhibitors within the 3 days prior to, the day of, or within 3 days after the completion of SRS

Note: chemotherapy and immunotherapy outside of this window are allowed

Locations

Karmanos Cancer Institute - Detroit Headquarters

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Detroit, MI 48201
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Phone: 800-527-6266

Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

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Farmington Hills, MI 48334
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Phone: 800-527-6266

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