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Comparing radiation treatment timing for brain cancer surgery

A Randomized Phase III Trial of Pre-Operative Compared to Post-Operative Stereotactic Radiosurgery in Patients With Resectable Brain Metastases

Phase 3 Interventional NRG Oncology · NCT05438212

This study tests whether giving radiation treatment before or after brain surgery helps people with brain metastases feel better and live longer.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment236 (estimated)
Ages18 Years and up
SexAll
SponsorNRG Oncology Academic / other
Drugs / interventionschemotherapy, immunotherapy, radiation
Locations191 sites (Phoenix, Arizona and 190 other locations)
Trial IDNCT05438212 on ClinicalTrials.gov

What this trial studies

This phase III trial evaluates the effectiveness of administering stereotactic radiosurgery (SRS) either before or after surgical resection in patients with brain metastases. The study aims to determine if pre-surgery SRS can improve outcomes such as local tumor progression, overall survival, and symptom burden compared to the standard post-surgery SRS. Participants will undergo assessments to measure cognitive function and quality of life, alongside imaging studies to monitor for adverse effects. The trial includes patients with 1-4 brain metastases, focusing on optimizing treatment strategies to enhance patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are patients with 1-4 brain metastases, one of which requires surgical resection, and who can tolerate surgery and SRS.

Not a fit: Patients with brain metastases located too close to critical structures like the optic chiasm or those with larger lesions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved survival rates and reduced symptoms for patients with brain metastases.

How similar studies have performed: Other studies have shown promising results with similar approaches, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 any lesions which will not be resected must be =\< 4.0 cm in maximum diameter
* 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
* Lesions chosen for surgical therapy must be deemed appropriate targets 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
* 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

Where this trial is running

Phoenix, Arizona and 190 other locations

+141 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
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Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.