About this trial
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.
Eligibility criteria
Qualifiers
Patient must have a primary diagnosis of malignancy and radiographic evidence of bone metastases. Eligible tumor histologies include the following malignancies with low alpha/beta ratios: renal cell carcinoma, urothelial carcinomas, castration-resistant prostate cancer, sarcoma, thyroid carcinoma, colorectal carcinoma, and melanoma
The target lesion must be amenable to both cryoablation and SBRT, as determined by the study principal investigators (PIs)
The target lesion must be =< 7cm
The pain due to the target lesion must be at least 4/10 based on the BPI pain scale
Disqualifiers
Prior locoregional therapy to target lesion, including ablation of any modality, embolization, radiation, or surgery
Patient may not be receiving any other investigational agents. Standard concurrent chemotherapy, immunotherapy, or targeted therapy will be allowed
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, interstitial lung disease, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant or nursing women; women of childbearing potential unless using effective contraception as determined by the investigator
Trial design
Treatments tested in this trial
- Cryosurgery
- Quality-of-Life Assessment
- Stereotactic Body Radiation Therapy
Treatment groups
Locations
1Sponsors and collaborators
M.D. Anderson Cancer Center
Lead sponsor