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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 30 days of the last study treatment
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 30 days of the last study treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 30 days of the last study treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain response
Secondary outcome measures
Daily morphine equivalent (MEDD)
Duration of response
Local control
+2 moreTrial 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
~780
Cryosurgery
2015
Completed Phase 4
~540
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,281 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to my spine or skull.I am not on any experimental drugs but may be on standard cancer treatments.I have a confirmed fracture at the cancer site that cannot be stabilized with a minimally invasive procedure.I have had treatments like surgery or radiation on a specific cancer area.Your blood clotting test (INR) should be less than 1.5 within 6 weeks of screening.I do not have any severe illnesses or conditions that would stop me from following the study's requirements.I am not pregnant or nursing, and if capable of becoming pregnant, I am using effective birth control.You are expected to live for at least 3 more months.Your body has very low levels of a type of white blood cell called neutrophils.I currently have an infection.My cancer can be treated with freezing and targeted radiation, as approved by the study leaders.My cancer has severely damaged the bone in my leg.My pain from the cancer area is at least a 4 out of 10.My pain matches the location of a tumor seen on scans.My cancer lesion is 7cm or smaller.I have cancer with bone spread from specific types like kidney, prostate, or skin.I am post-menopausal or not currently pregnant.Your blood platelet count is higher than 50,000 per cubic millimeter within 6 weeks before screening.I can stop my blood thinner medication 48 hours before the procedure if needed.I can have had any type of systemic therapy before.I am mostly active and can care for myself.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (SBRT)
- Group 2: Arm B (cryoablation, SBRT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Would this research endeavor welcome new participants?
"The trial is actively recruiting, as evidenced by the clinicaltrials.gov data which indicates that it was first launched on March 16th 2021 and had its most recent update made of August 18th 2022."
Answered by AI
How many subjects are currently being administered this clinical trial?
"Affirmative, the information available on clinicaltrials.gov confirms that this medical experiment is currently enrolling participants. This study was first published on March 16th 2021 and last updated on August 18th 2022. It requires 40 individuals at a single site for completion."
Answered by AI
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