Comparing Cryoablation Plus Stereotactic Body Radiation Therapy to Radiation Therapy Alone for Pain Relief in Patients with Painful Bone Metastases

What this Trial Is About

Researchers are evaluating how well cryoablation combined with stereotactic body radiation therapy SBRT works compared to SBRT alone in relieving pain from bone metastases, which are common in advanced cancers and often cause severe pain. The trial focuses on patients with various cancers that have spread to the bones, aiming to improve pain management beyond the current standard of radiation therapy alone. Participants are randomly assigned to one of two groups one group receives a single session of SBRT, while the other group undergoes cryoablation followed by SBRT within 10 days. Cryoablation involves inserting special needles into the tumor to freeze and kill cancer cells. This design allows researchers to compare the effects of combining cryoablation with SBRT against SBRT by itself. During the study, patients are monitored at multiple time points up to 24 weeks after treatment to assess pain relief, use of pain medication, tumor control, quality of life, and any side effects. Researchers also evaluate the technical success of cryoablation and study changes in the local tumor environment. The main outcome measured is pain response at 12 weeks post-treatment, with follow-ups continuing for several months.

Cryoablation Combined With Stereotactic Body Radiation Therapy for the Treatment of Painful Bone Metastases, the CROME Trial