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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
40
Undergo cryoablation
Ancillary studies
Undergo stereotactic body radiation therapy
M D Anderson Cancer Center
Houston, Texas, United States
RECRUITINGPain 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
Daily morphine equivalent (MEDD)
Time frame: Baseline, assessed up to 24 weeks post-treatment
Duration of response
Will be assessed by performing area under the curve (AUC) analysis of Brief Pain Inventory (BPI) pain scores.
Time frame: Up to 24 weeks post-treatment
Local control
Will be determined by imaging evidence of residual viable tumor. Standard of care cross-sectional imaging and bone scintigraphy will be performed at 3 month intervals.
Time frame: Up to 24 weeks post-treatment
Rate and severity of adverse and serious related adverse events
Point estimates and two-sided 95% confidence intervals will be generated for procedural related adverse events.
Time frame: Within 30 days of the last study treatment
Technical success for cryoablation
Will be determined by identifying on intra-procedural imaging when the leading edge of the ice successfully extends beyond the tumor margin by at least 5 mm.
Time frame: Up to 24 weeks post-treatment
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