Cryoablation Combined With Stereotactic Body Radiation Therapy for the Treatment of Painful Bone Metastases, the CROME Trial
2 other identifiers
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2020
CompletedFirst Posted
Study publicly available on registry
January 5, 2021
CompletedStudy Start
First participant enrolled
March 16, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
April 15, 2026
April 1, 2026
6 years
October 13, 2020
April 10, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Pain response
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.
At 12 weeks post-treatment
Secondary Outcomes (5)
Daily morphine equivalent (MEDD)
Baseline, assessed up to 24 weeks post-treatment
Duration of response
Up to 24 weeks post-treatment
Local control
Up to 24 weeks post-treatment
Rate and severity of adverse and serious related adverse events
Within 30 days of the last study treatment
Technical success for cryoablation
Up to 24 weeks post-treatment
Study Arms (2)
Arm A (SBRT)
ACTIVE COMPARATORPatients undergo stereotactic body radiation therapy for 1 fraction.
Arm B (cryoablation, SBRT)
EXPERIMENTALPatients undergo cryoablation. Within 10 days after cryoablation, patients undergo stereotactic body radiation therapy for 1 fraction. Alternatively, patients may receive stereotactic body radiation therapy initially, followed by cryoablation."
Interventions
Undergo cryoablation
Ancillary studies
Undergo stereotactic body radiation therapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Stringam J, Pal K, Niekamp A, Jiwani R, Paolucci I, Kuban JD, Metwalli Z, Huang S, Habibollahi P, Chen S, Yevich S, Patel M, Subudhi SK, Campbell M, Ghia A, Tatsui C, Sheth RA. Safety, Efficacy, and Adjacent-level Fracture Risk Following Vertebral Augmentation and Radiofrequency Ablation for the Treatment of Spine Metastases in Patients with Cancer. Radiol Imaging Cancer. 2025 May;7(3):e240122. doi: 10.1148/rycan.240122.
PMID: 40377420DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rahul A Sheth, MD
M.D. Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2020
First Posted
January 5, 2021
Study Start
March 16, 2021
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2027
Last Updated
April 15, 2026
Record last verified: 2026-04