Combining cryoablation and radiation therapy for painful bone metastases
Official title: Cryoablation Combined With Stereotactic Body Radiation Therapy for the Treatment of Painful Bone Metastases
Run by M.D. Anderson Cancer Center · NCT04693377 · Data updated 2026-11-12
This study is testing if combining a freezing treatment with radiation can help people with painful bone cancer feel better compared to just using radiation alone.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Houston, Texas) |
| Status | Recruiting |
| Started | March 16, 2021 |
| Main results expected | April 1, 2027 |
| Study ends | April 1, 2027 |
| Registry record updated | April 15, 2026 |
| Trial ID | NCT04693377 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with specific types of cancer that have spread to the bones and are experiencing significant pain.
✕Probably not a fit
Patients with bone metastases that are not amenable to cryoablation or SBRT may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial compares the effectiveness of cryoablation combined with stereotactic body radiation therapy (SBRT) against SBRT alone in treating patients suffering from pain due to bone metastases. Cryoablation involves inserting needles to freeze and destroy cancer cells, while SBRT delivers targeted radiation to the tumor. The study aims to assess pain relief, narcotic usage, local tumor control, quality of life, and any adverse effects. Patients will be randomized into two groups, one receiving only SBRT and the other receiving cryoablation followed by SBRT.
Why it matters
Potential benefit: If successful, this approach could significantly improve pain management for patients with painful bone metastases.
How similar studies have gone: While the combination of cryoablation and SBRT is a novel approach, previous studies have shown success with each treatment individually for pain relief in bone metastases.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * A target lesion the meets the following criteria: * 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 * Pain from the metastatic site must correlate with an identifiable tumor on computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound (US) imaging * Life expectancy \>= 3 months * Platelet count \> 50,000/mm\^3 within 6 weeks of screening * International normalized ratio (INR) \< 1.5 within 6 weeks of screening * If taking antiplatelet or anticoagulation medication, it must be able to be discontinued 48 hours prior to the procedure or at the discretion of the PI (e.g., aspirin, ibuprofen, low molecular weight heparin \[LMWH\] preparations) * Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky \>= 70%) within 6 weeks of screening * Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply: Women \< 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization. Women \>= 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \> 1 year ago, had chemotherapy-induced menopause with last menses \> 1 year ago, or underwent surgical sterilization * All lines of prior systemic therapy are permissible. Standard concurrent chemotherapy, immunotherapy, or targeted therapy are permissible * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * 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 * Target lesions that involve the spinal column or calvarium * Absolute neutrophil count \< 1000 mm\^3 within 6 weeks of screening * Active infection * Presence of confirmed pathologic fracture at the target lesion not amenable to percutaneous stabilization * Lesions that involve a weight-bearing long bone of the lower extremity with the tumor causing \> 50% loss of cortical bone. Lesions involving the hands and feet
Where it's running
-
M D Anderson Cancer Center
Houston, Texas, United States Recruiting
Study contacts
- Principal investigator: Rahul A Sheth, MD — M.D. Anderson Cancer Center
- Study coordinator: Rahul A. Sheth, MD
- Email: rasheth@mdanderson.org
- Phone: 713-745-0652
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.