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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study is for people with certain cancers that have spread to the bones and cause pain. It tests whether freezing tumors with special needles plus focused radiation gives better pain relief than focused radiation alone.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have cancer that scans show has spread to bone. Allowed cancers are kidney, urinary tract, prostate cancer that resists hormone-lowering treatment, sarcoma, thyroid, colon or rectal cancer, and melanoma.
- Have a bone tumor no larger than 7 cm that study doctors can treat with both freezing and focused radiation. The tumor must show on a scan and cause pain rated at least 4 out of 10.
- Be expected to live at least 3 months.
- Have a platelet count above 50,000 and an INR below 1.5 within 6 weeks of screening. These blood tests check how well your blood can clot.
- If taking blood-thinning medicines, be able to stop them 48 hours before the procedure, or as the study doctor directs.
- Be able to do most daily activities, with little or no help, and meet the study's activity score within 6 weeks of screening.
- Women must meet the study's rules for having gone through menopause or have a negative urine or blood pregnancy test.
- Be able to understand the study and willing to sign a consent form. Past cancer drug treatments and standard cancer drug treatments during the study are allowed.
Who can't join
- Have already had treatment aimed at the study tumor, such as freezing or other tumor destruction, blocking its blood supply, radiation, or surgery.
- Be receiving another experimental drug.
- Have an active infection or an uncontrolled illness, such as lung disease or serious heart problems, or mental health or social issues that would prevent following study rules.
- Be pregnant or breastfeeding, or able to become pregnant without using birth control approved by the study doctor.
- Have a study tumor in the spine, the bones at the top of the skull, a hand, or a foot.
- Have a neutrophil count below 1,000 within 6 weeks of screening. Neutrophils are white blood cells that fight infection.
- Have a confirmed cancer-related break in the bone at the study tumor that cannot be supported through a procedure using small openings in the skin.
- Have a tumor in a long leg bone that supports body weight, with more than half of the hard outer bone lost.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Patient must have a primary diagnosis of malignancy and radiographic evidence of bone metastases. Eligible tumor histologies include the following malignancies with low alpha/beta ratios: renal cell carcinoma, urothelial carcinomas, castration-resistant prostate cancer, sarcoma, thyroid carcinoma, colorectal carcinoma, and melanoma * A target lesion the meets the following criteria: * The target lesion must be amenable to both cryoablation and SBRT, as determined by the study principal investigators (PIs) * The target lesion must be =\< 7cm * 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 * Life expectancy \>= 3 months * Platelet count \> 50,000/mm\^3 within 6 weeks of screening * International normalized ratio (INR) \< 1.5 within 6 weeks of screening * If taking antiplatelet or anticoagulation medication, it must be able to be discontinued 48 hours prior to the procedure or at the discretion of the PI (e.g., aspirin, ibuprofen, low molecular weight heparin \[LMWH\] preparations) * Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky \>= 70%) within 6 weeks of screening * Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply: Women \< 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization. Women \>= 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \> 1 year ago, had chemotherapy-induced menopause with last menses \> 1 year ago, or underwent surgical sterilization * All lines of prior systemic therapy are permissible. Standard concurrent chemotherapy, immunotherapy, or targeted therapy are permissible * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Prior locoregional therapy to target lesion, including ablation of any modality, embolization, radiation, or surgery * Patient may not be receiving any other investigational agents. Standard concurrent chemotherapy, immunotherapy, or targeted therapy will be allowed * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, interstitial lung disease, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant or nursing women; women of childbearing potential unless using effective contraception as determined by the investigator * Target lesions that involve the spinal column or calvarium * Absolute neutrophil count \< 1000 mm\^3 within 6 weeks of screening * Active infection * Presence of confirmed pathologic fracture at the target lesion not amenable to percutaneous stabilization * Lesions that involve a weight-bearing long bone of the lower extremity with the tumor causing \> 50% loss of cortical bone. Lesions involving the hands and feet
Study sites (1)
TX
- M D Anderson Cancer Center · Houston, TX 77030Rahul A. Sheth, MD · Study contact · 713-745-0652Rahul A. Sheth, MD · Principal investigatorMore trials in Houston