Cryoablation Combined With Stereotactic Body Radiation Therapy for the Treatment of Painful Bone Metastases
Summary
This trial compares cryoablation combined with stereotactic body radiation therapy to stereotactic body radiation therapy alone to see how well they work in treating patients with pain from cancer that has spread to the bones (bone metastases). Bone is a common site of metastasis in advanced cancer, and bone metastases often result in debilitating cancer-related pain. The current standard of care to treat painful bone metastases is radiation therapy alone. However, many patients do not get adequate pain relief from radiation therapy alone. Another type of therapy that may be used to provide pain relief from bone metastases is cryoablation. Cryoablation is a procedure in which special needles are inserted into the tumor site. These needles grow ice balls at their tips to freeze and kill cancer cells. The goal of this trial is to compare how well cryoablation in combination with radiation therapy works to radiation therapy alone when given to cancer patients to provide pain relief from bone metastases.
Detailed description
PRIMARY OBJECTIVE: I. To determine the efficacy of cryoablation in combination with stereotactic body radiation therapy (SBRT) or SBRT only for the treatment of painful bone metastases. SECONDARY OBJECTIVES: I. To assess for narcotics utilization by daily morphine equivalent dose. II. To assess duration of pain response reported by International Pain Response Criteria. III. To assess for local tumor control. IV. To assess for changes in patient quality of life with Brief Pain Inventory (BPI) score. V. To assess for adverse event rates. VI. To assess incidence and severity of adverse events/toxicity. VII. To assess technical success for cryoablation. EXPLORATORY OBJECTIVE: I. To investigate the local microenvironmental changes following SBRT and cryoablation combined with SBRT to bone metastases. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients undergo stereotactic body radiation therapy for 1 fraction. ARM B: Patients undergo cryoablation. Within 10 days after cryoablation, patients undergo stereotactic body radiation therapy for 1 fraction. After completion of study treatment, patients are followed up at 1, 2, 3, 4, 8, 12, 16, 20, and 24 weeks.
Arms & interventions
- ProcedureCryosurgery
Undergo cryoablation
- OtherQuality-of-Life Assessment
Ancillary studies
- RadiationStereotactic Body Radiation Therapy
Undergo stereotactic body radiation therapy
Outcome measures
Primary
Pain response
Defined as complete or partial response as reported by the International Pain Response Criteria at the site of the treated bone metastasis based on the BPI pain score and daily morphine equivalent (MEDD). Will be summarized separately for each treatment arm with associated 95% exact confidence intervals.
Time frame: At 12 weeks post-treatment
Secondary
Daily morphine equivalent (MEDD)
Time frame: Baseline, assessed up to 24 weeks post-treatment
Duration of response
Time frame: Up to 24 weeks post-treatment
Local control
Time frame: Up to 24 weeks post-treatment
Rate and severity of adverse and serious related adverse events
Time frame: Within 30 days of the last study treatment
Technical success for cryoablation
Time frame: Up to 24 weeks post-treatment
Eligibility criteria
Study locations (1)
M D Anderson Cancer Center
Houston, Texas, 77030
References
- Stringam J, Pal K, Niekamp A, Jiwani R, Paolucci I, Kuban JD, Metwalli Z, Huang S, Habibollahi P, Chen S, Yevich S, Patel M, Subudhi SK, Campbell M, Ghia A, Tatsui C, Sheth RA. Safety, Efficacy, and Adjacent-level Fracture Risk Following Vertebral Augmentation and Radiofrequency Ablation for the Treatment of Spine Metastases in Patients with Cancer. Radiol Imaging Cancer. 2025 May;7(3):e240122. doi: 10.1148/rycan.240122.(PubMed)