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Freezing Bone Tumors Plus Radiation for Painful Cancer Spread to Bone

Tests freezing bone tumors with radiation in adults with cancer pain from bone spread.

Key facts

Who runs it
M.D. Anderson Cancer Center
Where
Houston, United StatesSee the site
Trial code
Registry title
Cryoablation Combined With Stereotactic Body Radiation Therapy for the Treatment of Painful Bone Metastases, the CROME Trial
Status
Recruiting
People taking part
40 people, planned
Started
16 Mar 2021
Expected to end
1 Apr 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Cryosurgery
  • Quality-of-Life Assessment
  • Stereotactic Body Radiation Therapy
Record updated
15 April 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with pain from cancer that has spread to the bone. It compares freezing treatment (cryoablation) plus focused radiation with focused radiation alone.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Cancer that has spread to the bone, from kidney, urothelial, castration-resistant prostate, sarcoma, thyroid, colorectal cancer or melanoma. The painful bone tumor must be 7cm (2.8 in) or smaller and cause pain of at least 4/10.
Earlier treatment
All earlier drug treatments are allowed. The painful bone tumor must not have had earlier local treatment such as ablation, embolization, radiation or surgery.

Main reasons for not taking part

  • Painful tumor in the spine or skull
  • Confirmed fracture at the tumor that cannot be stabilised through the skin
  • Pregnant or nursing women
  • Active infection or uncontrolled other illness
  • Taking any other investigational agent

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • Active infection
  • Absolute neutrophil count < 1000 mm\^3 within 6 weeks of screening
  • 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
  • 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 in United States

  • M D Anderson Cancer CenterHouston, United StatesContact: Rahul A. Sheth, MDTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Arm A (SBRT)Existing treatment, for comparison

    Patients undergo stereotactic body radiation therapy for 1 fraction.

    Treatment: Quality-of-Life Assessment and Stereotactic Body Radiation Therapy

  • Arm B (cryoablation, SBRT)Treatment being tested

    Patients 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."

    Treatment: Cryosurgery, Quality-of-Life Assessment, and Stereotactic Body Radiation Therapy

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Cryoablation Combined With Stereotactic Body Radiation Therapy for the Treatment of Painful Bone Metastases
Plain-language title
Freezing Bone Tumors Plus Radiation for Painful Cancer Spread to BoneGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
15 April 2026