Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04693377

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

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

40

Participants Needed

1

Research Sites

315 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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. The current standard of care to treat painful bone metastases is radiation therapy alone. However, many patients do not get adequate pain relief from radiation therapy alone. Another type of therapy that may be used to provide pain relief from bone metastases is cryoablation. Cryoablation is a procedure in which special needles are inserted into the tumor site. These needles grow ice balls at their tips to freeze and kill cancer cells. The goal of this trial is to compare how well cryoablation in combination with radiation therapy works to radiation therapy alone when given to cancer patients to provide pain relief from bone metastases.

CONDITIONS

Official 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 must have a primary diagnosis of cancer and radiographic evidence of bone metastases from specified tumor types with low alpha/beta ratios, including renal cell carcinoma, urothelial carcinomas, castration-resistant prostate cancer, sarcoma, thyroid carcinoma, colorectal carcinoma, and melanoma
  • Target lesion must be suitable for both cryoablation and stereotactic body radiation therapy (SBRT) as determined by study investigators
  • Target lesion must be 7 cm or smaller
  • Pain from the target lesion must be at least 4 out of 10 on the Brief Pain Inventory scale
  • Pain must match an identifiable tumor seen on CT, MRI, or ultrasound imaging
  • Life expectancy of at least 3 months
  • Platelet count above 50,000/mm³ within 6 weeks before screening
  • International normalized ratio (INR) less than 1.5 within 6 weeks before screening
  • If taking blood-thinning medications, they must be able to be stopped 48 hours before the procedure or as decided by the investigator
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Karnofsky score 70% or higher) within 6 weeks before screening
  • Women must be post-menopausal or have a negative pregnancy test if pre-menopausal, with specific criteria based on age and hormonal status
  • All prior systemic cancer treatments are allowed
  • Ability to understand and sign the informed consent form
Not Eligible

You will not qualify if you...

  • Prior local treatment to the target lesion, including any ablation, embolization, radiation, or surgery
  • Receiving any other investigational agents aside from allowed standard cancer therapies
  • Uncontrolled illnesses such as active infection, lung disease, heart failure, unstable angina, arrhythmia, or psychiatric/social issues affecting 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 the time of screening
  • Presence of a confirmed pathological fracture at the target lesion that cannot be stabilized with a needle procedure
  • Lesions in weight-bearing long bones of the lower limb causing 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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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

CONTACT

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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