Phase III Study Comparing Stereotactic Body Radiation Therapy SBRT and Conventional Radiation for Painful Bone Metastases

What this Trial Is About

This trial investigates the use of stereotactic body radiation therapy SBRT compared to conventional palliative radiation therapy for people with painful bone metastases caused by solid tumors. The study aims to find out which radiation schedule and dose better relieve pain, with pain response measured at multiple time points up to several months after treatment. The research also evaluates treatment safety, survival, and quality of life outcomes. Participants receive radiation therapy in one of two groups standard dose or high dose. The standard dose group may get 8 Gy in one session or 20 Gy over five sessions, while the high dose group may receive 16 Gy in one session or 27 Gy over three sessions. Radiation treatments are given daily over consecutive days, not counting weekends or holidays, depending on the assigned schedule. During the study, participants will have their pain assessed at 2 weeks, 1 month, 3 months, and then every 3 months after treatment. Researchers will also review imaging to check for cancer progression, monitor pain medication use, record any additional treatments or surgeries, and track side effects. Quality of life surveys will be completed, and adverse events will be followed for about one year. The total time participants are involved depends on follow-up schedules and treatment response.

A Phase III Randomized Trial Comparing Stereotactic Body Radiation Therapy (SBRT) vs Conventional Palliative Radiation Therapy for Painful Bone Metastases