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CROME Trial: Cryoablation and Radiation for Painful Bone Metastases

This study, called the CROME trial, is looking at new ways to treat pain caused by cancer that has spread to the bones (bone metastases). It compares two treatments: stereotactic body radiation therapy (a type of focused radiation) alone, versus stereotactic body radiation therapy combined with cryoablation (a procedure using extreme cold to destroy tissue). The goal is to see which approach is more effective at reducing pain. You might be able to join if you have painful bone metastases from certain types of cancer, such as prostate, colorectal, or melanoma. The main way they will measure success is by checking your pain levels 12 weeks after treatment. The current recruitment status for this trial is unclear.

Study design
This is an interventional study with a planned enrollment of 40 participants. Participants will be randomly assigned to receive either stereotactic body radiation therapy alone or cryoablation followed by stereotactic body radiation therapy.
What's involved
Participants will undergo either stereotactic body radiation therapy or cryoablation followed by stereotactic body radiation therapy. There will be follow-up visits at 1, 2, 3, 4, 8, 12, 16, 20, and 24 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 24 weeks after completing their study treatment to assess pain response and other outcomes.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04693377

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

Recruiting
NAAges 18+InterventionalSupportive care
M.D. Anderson Cancer Center
~40 participants
Updated 2026-04-15 on ClinicalTrials.gov
What's tested:CryosurgeryQuality-of-Life AssessmentStereotactic Body Radiation Therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pain response
Measured over At 12 weeks post-treatment

Conditions

Castration-Resistant Prostate Carcinoma
Metastatic Colorectal Carcinoma
Metastatic Malignant Neoplasm in the Bone
Metastatic Malignant Solid Neoplasm
Metastatic Melanoma
Metastatic Prostate Carcinoma
Metastatic Renal Cell Carcinoma
Metastatic Sarcoma
Metastatic Thyroid Gland Carcinoma
Metastatic Urothelial Carcinoma
Stage IV Colorectal Cancer AJCC v8
Stage IV Prostate Cancer AJCC v8
Stage IV Renal Cell Cancer AJCC v8
Stage IVA Colorectal Cancer AJCC v8
Stage IVA Prostate Cancer AJCC v8
Stage IVB Colorectal Cancer AJCC v8
Stage IVB Prostate Cancer AJCC v8
Stage IVC Colorectal Cancer AJCC v8

Explore related trials

Colorectal CarcinomaMelanomaProstate CarcinomaRenal Cell CarcinomaSarcomaSolid NeoplasmThyroid Gland CarcinomaUrothelial Carcinoma

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Rahul A Sheth, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Rahul A. Sheth, MD
[email protected]
713-745-0652
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Pain responseAt 12 weeks post-treatment

    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.