A Randomised, Prospective Study Comparing Single-Fraction Ablative Radiosurgery to Five-Fraction Stereotactic Radiotherapy With Simultaneous Integrated Boost for Bone Lesions in Oligometastatic Disease

What this Trial Is About

Researchers are evaluating two types of stereotactic ablative radiotherapy for treating bone metastases in patients with oligometastatic cancer, where cancer has spread to a limited number of sites. This randomized, prospective study conducted at a single institution compares radiosurgery delivered in one high-dose fraction to a five-fraction stereotactic radiotherapy with a simultaneous integrated boost (SIB). The study aims to understand which approach better controls local disease while monitoring safety and quality of life outcomes over three years. Participants are randomly assigned to one of two treatment groups: Arm A receives a single fraction of radiosurgery delivering 21-24 Gy to bone metastases, while Arm B receives five daily fractions of stereotactic ablative radiotherapy with an SIB delivering up to 40-50 Gy. The treatments begin within 15 days after simulation CT and are completed within 45 days from randomization. Both treatment methods are part of routine clinical practice in specialized centers. During the study, patients will be assessed through clinical visits at the end of treatment and at 3, 6, 12, 18, 24, and 36 months afterward. These visits include imaging tests such as CT, bone scans, MRI, or PET/CT depending on tumor location and history, along with physical exams and laboratory tests. Researchers will monitor local recurrence-free survival, toxicity, pain control, overall survival, disease progression, and quality of life using standardized questionnaires and pain diaries. Follow-ups occur in the radiation oncology department to ensure comprehensive monitoring of treatment effects and safety.

Ablative Radiosurgery vs Stereotactic RT in 5 Fractions With SIB for Oligometastatic Bone Lesions