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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

No Placebo-Only Group

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 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

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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