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Procedure

Cryoablation + SBRT for Bone Metastasis Pain

N/A
Recruiting
Led By Rahul A Sheth, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
Target lesions that involve the spinal column or calvarium
Presence of confirmed pathologic fracture at the target lesion not amenable to percutaneous stabilization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 30 days of the last study treatment
Awards & highlights

Summary

This trial is comparing two ways of treating patients with pain from cancer that has spread to the bones (bone metastases). The first way is cryoablation combined with stereotactic body radiation therapy. The second way is just stereotactic body radiation therapy alone.

Who is the study for?
This trial is for cancer patients with painful bone metastases from specific cancers like renal, urothelial, prostate, sarcoma, thyroid, colorectal carcinoma and melanoma. Participants must have a pain score of at least 4/10 on the BPI scale for the affected bone area and a life expectancy of 3+ months. They should be able to stop antiplatelet or anticoagulation meds before procedures if needed.
What is being tested?
The CROME Trial is testing whether combining cryoablation (freezing cancer cells using special needles) with stereotactic body radiation therapy provides better pain relief for bone metastases than radiation alone. Patients will either receive both treatments or just radiation to compare effectiveness.
What are the potential side effects?
Potential side effects include discomfort or bruising where needles are inserted for cryoablation, typical risks associated with radiation such as skin irritation and fatigue, and less commonly tissue damage around treated bones.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My pain from the cancer area is at least a 4 out of 10.
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My pain matches the location of a tumor seen on scans.
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My cancer lesion is 7cm or smaller.
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I have cancer with bone spread from specific types like kidney, prostate, or skin.
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I am post-menopausal or not currently pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has spread to my spine or skull.
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I have a confirmed fracture at the cancer site that cannot be stabilized with a minimally invasive procedure.
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I have had treatments like surgery or radiation on a specific cancer area.
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I do not have any severe illnesses or conditions that would stop me from following the study's requirements.
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I currently have an infection.
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My cancer has severely damaged the bone in my leg.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 30 days of the last study treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 30 days of the last study treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pain response
Secondary study objectives
Duration of response
Local control
Rate and severity of adverse and serious related adverse events
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm B (cryoablation, SBRT)Experimental Treatment3 Interventions
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."
Group II: Arm A (SBRT)Active Control2 Interventions
Patients undergo stereotactic body radiation therapy for 1 fraction.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~790
Cryosurgery
2015
Completed Phase 4
~550

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,039 Previous Clinical Trials
1,799,661 Total Patients Enrolled
Rahul A Sheth, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
150 Total Patients Enrolled
Rahul A ShethPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
500 Total Patients Enrolled

Media Library

Cryoablation (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04693377 — N/A
Colorectal Cancer Research Study Groups: Arm A (SBRT), Arm B (cryoablation, SBRT)
Colorectal Cancer Clinical Trial 2023: Cryoablation Highlights & Side Effects. Trial Name: NCT04693377 — N/A
Cryoablation (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04693377 — N/A
~17 spots leftby Apr 2027
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