Brain Metastases in Greater Size - Hypofractionated Options Trial (BIGSHOT)
Medical University of South Carolina
Summary
This is a randomized, phase II trial comparing staged stereotactic radiosurgery (SSRS) versus fractionated stereotactic radiotherapy (FSRT) in patients with large brain metastases (≥2 cm and ≤5 cm). The study aims to evaluate efficacy, safety, and tumor response between these two standard-of-care radiation approaches.
Description
Brain metastases are an increasingly common diagnosis, as cancer patients continue to live longer due to advances in systemic therapy. Up to 26% of patients with metastatic cancer will develop metastatic disease to the brain (Nayak 2012), most commonly in lung cancer, as well as melanoma, breast, and renal cell cancer (Singh 2020). Historically, brain metastases were treated with whole brain radiation therapy (WBRT). However, increasing evidence over the past 10-15 years, as well as technological advances, have created a shift in treatment toward stereotactic radiosurgery (SRS), which is a foc…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. The patient or a legally authorized representative must be able and willing to provide study-specific informed consent prior to study entry. 2. Patient must be willing to comply with all study procedures and available for the duration of the study 3. Male or female, aged ≥ 18 years 4. Karnofsky Performance Status (KPS) ≥ 60 within 7 days prior to registration 5. Radiographic confirmation of brain metastasis measuring ≥2 cm and ≤ 5 cm in maximum diameter 1. Multiple metastases are allowed. Additional metastases will be treated with single fraction SRS as per standard…
Interventions
- RadiationStaged Stereotactic Radiosurgery (SSRS)
The large brain metastasis (or metastases) will be treated to a dose of 24-30 Gy in two fractions. Interval between the two fractions will be 30 days (+/- 10 days). Individual dosing for each fraction will be determined by the treating radiation oncologist, but total dose must equal 24-30 Gy.
- RadiationFractionated Stereotactic Radiotherapy (FSRT)
Fractionation will be 27 Gy in 3 daily fractions. The 3 daily fractions must be completed over a period of 3-5 days.
Location
- Medical University of South Carolina Hollings Cancer CenterCharleston, South Carolina