About this trial
NRG-BN013 is a clinical study for people with cancer that has spread to the brain, also known as brain metastases. This study is specifically for patients who are eligible to receive radiation therapy for their brain tumours.
Researchers are conducting this study to compare two different types of radiation therapy: the standard one-day treatment called Single Fraction Stereotactic Radiosurgery (SRS) and an alternative approach called Fractionated Stereotactic Radiosurgery (FSRS), which involves three treatments over about one week.
The goal of the study is to find out if FSRS is more effective at treating brain metastases than the usual SRS treatment. Both treatments use highly precise radiation to target tumours while sparing healthy tissue.
This study will help doctors determine if FSRS can provide better outcomes, such as improved tumour control or reduced cancer progression, compared to the standard SRS approach.
Patient Profile
The inclusion criteria for research participants in the study
1. Cancer Diagnosis: Pathologically proven diagnosis (histological or cytological) of one of the following solid tumour malignancies within 5 years prior to registration:
•Non-small cell lung cancer
•Melanoma
•Breast cancer
•Renal cell carcinoma
•Gastrointestinal cancer
•If the original diagnosis was made over 5 years ago, more recent confirmation from a systemic site or brain metastasis or imaging confirmation of extracranial metastatic disease (e.g., CT, PET/CT) is required.
2.Brain Metastases: 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 lesion must meet the following criteria:
•Maximum diameter of ≥ 1.0 cm and ≤ 3.0 cm
•Located outside of the brainstem and ≥ 5 mm from the optic nerves or optic chiasm
•No more than 2 lesions planned for resection if clinically indicated.
•No known leptomeningeal disease
3. Graded Prognostic Assessment: Diagnosis-specific graded prognostic assessment (GPA) score of ≥ 1.5.
4. Age: Participants must be 18 years or older.
5. Karnofsky Performance Status (KPS): KPS score of ≥ 60.
6. Pregnancy Status: For participants of childbearing potential, a negative urine or serum pregnancy test within 14 days prior to registration.
7. No Previous Brain Radiotherapy: No prior radiotherapy to the brain, including whole-brain irradiation, stereotactic radiosurgery (SRS), fractionated stereotactic radiosurgery (FSRS), or prophylactic cranial irradiation.
8. General Health: Participants should have a level of health that allows them to complete the study requirements and follow-up period.
9. Comorbid Conditions:
•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 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;
Participants must meet these criteria in order to be eligible for the study.
Where’s this trial being run?
Bon Secours Radiotherapy Cork in Partnership with UPMC Hillman Cancer Centre
Can I join this study / trial?
The first step we recommend is to talk to your doctor or the cancer trials team at your hospital. You can find contact details for cancer trials research units in Ireland here.
It’s also a good idea to print this page and bring it with you to your appointment. It can help guide the conversation and remind you of what to ask. You may also want to talk to your family or friends about your options, as they can offer support as you make decisions.
For more detailed information
Click HereQuestions?
Here’s a list of questions you may have for your doctor or local cancer research team.
QuestionsSummary Data
| Name: | NRG BN013 study |
|---|---|
| Number: | 24-87 |
| Full Title: | Phase III trial of Single Fraction Stereotactic Radiosurgery (SRS) versus Fractionated SRS (FSRS) for intact brain metastases |
| Principal Investigator: | Dr Paul Kelly |
|---|---|
| Type: | Collaborative |
| Sponsor: | NRG Oncology |
| Recruitment Started: |
Global: Dec 2024 Ireland: Feb 2026 |
| Global Recruitment Target: | |
|---|---|
| Ireland Recruitment Target: |