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Official title Cryoablation Combined With Stereotactic Body Radiation Therapy for the Treatment of Painful Bone Metastases, the CROME Trial
ClinicalTrials.gov ID: NCT04693377
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient must have a primary diagnosis of malignancy and radiographic evidence of bone metastases. Eligible tumor histologies include the following...
- 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
You likely can't join 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...
- 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
See the full eligibility 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...
- 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]...
- Eastern Cooperative Oncology Group (ECOG) performance status =\ = 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...
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.