Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID04693377

Cryoablation Combined With Stereotactic Body Radiation Therapy for the Treatment of Painful Bone Metastases

Led by M.D. Anderson Cancer Center · Updated on 2026-04-15

40

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating how well cryoablation combined with stereotactic body radiation therapy (SBRT) works compared to SBRT alone in relieving pain from bone metastases, which are common in advanced cancers and often cause severe pain. The trial focuses on patients with various cancers that have spread to the bones, aiming to improve pain management beyond the current standard of radiation therapy alone. Participants are randomly assigned to one of two groups: one group receives a single session of SBRT, while the other group undergoes cryoablation followed by SBRT within 10 days. Cryoablation involves inserting special needles into the tumor to freeze and kill cancer cells. This design allows researchers to compare the effects of combining cryoablation with SBRT against SBRT by itself. During the study, patients are monitored at multiple time points up to 24 weeks after treatment to assess pain relief, use of pain medication, tumor control, quality of life, and any side effects. Researchers also evaluate the technical success of cryoablation and study changes in the local tumor environment. The main outcome measured is pain response at 12 weeks post-treatment, with follow-ups continuing for several months.

CONDITIONS

Brief Title

Cryoablation Combined With Stereotactic Body Radiation Therapy for the Treatment of Painful Bone Metastases, the CROME Trial

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient has a primary diagnosis of cancer with radiographic evidence of bone metastases from specific tumor types including renal cell carcinoma, urothelial carcinoma, castration-resistant prostate cancer, sarcoma, thyroid carcinoma, colorectal carcinoma, or melanoma
  • Target lesion must be suitable for both cryoablation and stereotactic body radiation therapy (SBRT) as determined by investigators
  • Target lesion size must be 7 cm or smaller
  • Pain from the target lesion must be at least 4 out of 10 on the Brief Pain Inventory pain scale
  • Pain must correlate with an identifiable tumor on CT, MRI, or ultrasound imaging
  • Life expectancy of 3 months or longer
  • Platelet count greater than 50,000/mm3 within 6 weeks before screening
  • International normalized ratio (INR) less than 1.5 within 6 weeks before screening
  • If on blood-thinning medications, they can be stopped 48 hours before the procedure or as allowed by the investigator
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Karnofsky score 70% or higher) within 6 weeks before screening
  • For women, evidence of post-menopausal status or negative pregnancy test if pre-menopausal
  • All prior systemic therapies allowed; concurrent chemotherapy, immunotherapy, or targeted therapy allowed
  • Ability to understand and sign informed consent
Not Eligible

You will not qualify if you...

  • Previous local therapy to the target lesion such as ablation, embolization, radiation, or surgery
  • Currently receiving any other investigational agents (standard chemotherapy, immunotherapy, or targeted therapy allowed)
  • Uncontrolled illnesses like active infections, interstitial lung disease, symptomatic heart failure, unstable angina, arrhythmias, or psychiatric/social conditions limiting study compliance
  • Pregnant or nursing women; women of childbearing potential not using effective contraception
  • Target lesions involving the spinal column or skull
  • Absolute neutrophil count below 1000/mm3 within 6 weeks before screening
  • Active infection at screening
  • Confirmed pathological fracture at the target lesion that cannot be stabilized percutaneously
  • Lesions involving weight-bearing long bones of the lower extremity with more than 50% loss of cortical bone
  • Lesions involving the hands or feet

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 10 days

Participants undergo stereotactic body radiation therapy (SBRT) alone or cryoablation followed by SBRT within 10 days.

1 to 2 visits depending on treatment arm

Follow-up

Duration - Up to 24 weeks post-treatment

Participants are monitored for pain response, narcotic use, tumor control, quality of life, and adverse events after treatment.

Visits at 1, 2, 3, 4, 8, 12, 16, 20, and 24 weeks

Trial Site Locations

Total: 1 location

1

M D Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

R

Rahul A. Sheth, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Published Research Related To This Trial

Safety, Efficacy, and Adjacent-level Fracture Risk Following Vertebral Augmentation and Radiofrequency Ablation for the Treatment of Spine Metastases in Patients with Cancer.

Jeremiah Stringam, Koustav Pal, Andrew Niekamp...

https://pubmed.ncbi.nlm.nih.gov/40377420