Adding a New Approach to Radiation Therapy for Brain Cancer Patients

Recruiting · Phase 3 · Anatomic Stage IV Breast Cancer AJCC v8 and related conditions · 37 states

Check if I qualify View on ClinicalTrials.gov

About this trial

This clinical trial looks at two types of radiation therapy for patients with cancer that has spread to the brain. One type is called Stereotactic Radiosurgery (SRS), which gives a single large dose of radiation. The other is Fractionated Stereotactic Radiosurgery (FSRS), which spreads the radiation over three treatments. The main goal is to see if FSRS is better at preventing the cancer from returning in the brain.

This trial is identified as NCT06500455. It is a Phase 3 trial, meaning it is looking at how well the treatment works and how safe it is. This trial is not FDA-regulated for drugs or devices and hopes to include 269 participants.

Who can join

This trial is open to adults aged 18 and older, including men and women. Participants must have certain types of cancer and intact brain metastases detected on an MRI. They should not have received prior radiation to the brain and should not have certain medical conditions. The trial team will confirm who can join.

Conditions

Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic Digestive System Carcinoma, Metastatic Lung Non-Small Cell Carcinoma, Metastatic Malignant Neoplasm in the Brain, Metastatic Malignant Solid Neoplasm, Metastatic Melanoma, Metastatic Renal Cell Carcinoma, Stage IV Lung Cancer AJCC v8, Stage IV Renal Cell Cancer AJCC v8

Age group

Adult, Older adult

Sex

All sexes

The study team makes the final call on eligibility.

What happens in the study

Participants will be randomly placed into one of two groups. One group will receive SRS, getting all treatment in one session. The other group will receive FSRS, with treatment over three sessions. All participants will also have CT and MRI scans during the study. Everyone will be followed up for several years after treatment.