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Cryoablation Combined With Stereotactic Body Radiation Therapy for the Treatment of Painful Bone Metastases, the CROME Trial

Sponsor: M.D. Anderson Cancer Center · NCT04693377 on ClinicalTrials.gov ↗

Conditions studied

Castration-Resistant Prostate CarcinomaMetastatic Colorectal CarcinomaMetastatic Malignant Neoplasm in the BoneMetastatic Malignant Solid NeoplasmMetastatic MelanomaMetastatic Prostate CarcinomaMetastatic Renal Cell CarcinomaMetastatic SarcomaMetastatic Thyroid Gland CarcinomaMetastatic Urothelial CarcinomaStage IV Colorectal Cancer AJCC v8Stage IV Prostate Cancer AJCC v8Stage IV Renal Cell Cancer AJCC v8Stage IVA Colorectal Cancer AJCC v8Stage IVA Prostate Cancer AJCC v8Stage IVB Colorectal Cancer AJCC v8Stage IVB Prostate Cancer AJCC v8Stage IVC Colorectal Cancer AJCC v8

What it tests

  • Cryosurgeryprocedure
  • Quality-of-Life Assessmentother
  • Stereotactic Body Radiation Therapyradiation

Where it's running1 site

  • M D Anderson Cancer Center

    Houston, Texas 77030

    Recruiting now
    • Rahul A. Sheth, MD(contact)713-745-0652
    • Rahul A. Sheth, MD(principal investigator)
See the official eligibility language

Shown exactly as written on ClinicalTrials.gov. Your oncologist is the right person to judge whether it fits your situation.

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

Updated 2026-04-15 on ClinicalTrials.gov. Always confirm current details with the study team or your oncologist.