PHASE III TRIAL OF SINGLE FRACTION STEREOTACTIC RADIOSURGERY (SRS) VERSUS FRACTIONATED SRS (FSRS) FOR INTACT BRAIN METASTASES
About this trial
The NRG BN013 (CTRIAL-IE 24-87) is currently open at:
- Bon Secours UPMC Cork
It will also open shortly at:
- St. Luke’s Radiation Oncology Network
- Cork University Hospital
- University Hospital Galway
What is the goal of this study?
The goal of this study is to find out whether giving stereotactic radiosurgery in three treatments (called fractionated SRS or FSRS) works as well as or better than the usual single-treatment stereotactic radiosurgery (SRS) for brain metastases. In particular, the study aims to see if the three-treatment approach can delay the time until the cancer in the brain grows back or gets worse, while carefully monitoring side effects.
What happens to patients as part of this trial?
- Consent: If you are interested in taking part, the study team will explain the trial in detail, answer your questions, and ask you to sign a consent form. Taking part is completely voluntary, and you can withdraw at any time without affecting your usual care.
- Randomisation: If you are eligible and agree to participate, a computer will randomly assign you (by chance) to receive either the standard single-treatment stereotactic radiosurgery (SRS) or the three-treatment approach (fractionated SRS, FSRS). Neither you nor your doctor can choose the group.
- Treatment: You will receive radiation to the brain metastases either in one session (SRS) or over three sessions across several days (FSRS). Both treatments are delivered using highly focused radiation aimed at the cancer while minimising exposure to healthy brain tissue.
- Follow-up: After treatment, you will have regular check-ups and MRI scans to monitor how you are doing, check for side effects, and see how the cancer is responding. Follow-up continues for up to five years after treatment.
Who can take part?
- Adults (18 years or older) who have been diagnosed with certain types of cancer (such as lung cancer, breast cancer, melanoma, kidney cancer, or gastrointestinal cancer) that have spread to the brain.
- Patients with 1 to 8 brain metastases seen on a recent MRI scan, with at least one tumour measuring between 1 cm and 3 cm in size, and who have not previously received radiation treatment to the brain.
- Patients who are well enough for treatment, with a reasonable level of daily functioning, and who are not pregnant or breastfeeding.
Study Oversight
Dr. Paul Kelly is the Chief Investigator of the study in Ireland.
The study is sponsored nationally by Cancer Trials Ireland.
NRG Oncology are the international study sponsors and Professor Rupesh Kotecha is the Sponsor-Investigator.