RecruitingNot ApplicableNCT04693377

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

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


Sponsor

M.D. Anderson Cancer Center

Enrollment

40 participants

Start Date

Mar 16, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (called CROME) combines two treatments — cryoablation (freezing the tumor) and stereotactic body radiation (precisely targeted radiation) — to treat painful bone metastases in cancers that often respond poorly to radiation alone, such as kidney cancer, prostate cancer, melanoma, and others. **You may be eligible if...** - You have a confirmed cancer diagnosis with bone metastases visible on imaging - Your cancer is one of the eligible types: renal cell carcinoma, urothelial cancer, castration-resistant prostate cancer, sarcoma, thyroid cancer, colorectal cancer, or melanoma - Your target bone lesion is 7 cm or smaller - Your pain from the bone lesion is at least 4 out of 10 on a pain scale - The lesion is suitable for both cryoablation and radiation (as determined by the study team) **You may NOT be eligible if...** - Your lesion is larger than 7 cm or cannot safely undergo both procedures - Your pain level is below 4 out of 10 - Your cancer type is not on the eligible list Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURECryosurgery

Undergo cryoablation

OTHERQuality-of-Life Assessment

Ancillary studies

RADIATIONStereotactic Body Radiation Therapy

Undergo stereotactic body radiation therapy


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT04693377


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