Phase 2 Study of Higher Dose Radiation Therapy for Pain Relief in Painful Non-Spinal Bone and Non-Bone Metastases

What this Trial Is About

This research aims to evaluate dose escalation in radiation therapy for patients with painful non-spinal bone metastases and painful non-bone metastases. The goal is to increase the complete pain response rate at one month by delivering higher doses of radiation in a carefully controlled manner. Researchers also seek to assess whether this intensified treatment leads to more durable pain relief, better quality of life, and acceptable safety in patients with cancer spread to bones or other areas. Participants will receive external beam radiation therapy with a prescribed dose of 50 Gy given in 10 fractions, though this may be reduced to 40 Gy in 8 fractions for some non-spinal metastases to protect normal tissues. Radiation treatments are delivered daily with a minimum of three sessions per week, and any missed treatments will be made up to complete the planned course. If participants experience unacceptable side effects but still benefit from the treatment, they may be allowed to continue under investigator discretion. During the study, participants will be monitored for safety by tracking adverse events and treatment-related toxicity within one month post-treatment. Researchers will also evaluate pain severity, duration of pain relief, quality of life changes, and the need for retreatment due to disease progression. The total participation time varies with follow-up assessments focusing on treatment impact and safety outcomes. The study is sponsored by Rutgers, The State University of New Jersey, and is designed as a phase 2 interventional trial.

Palliative Dose Escalated Radiation for Painful Non-Spine Bone Metastases and Painful Non-Bone Metas