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.
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
