NCT04693377

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. To determine the efficacy of cryoablation in combination with stereotactic body radiation therapy (SBRT) or SBRT only for the treatment of painful bone metastases. SECONDARY OBJECTIVES: I. To assess for narcotics utilization by daily morphine equivalent dose. II. To assess duration of pain response reported by International Pain Response Criteria. III. To assess for local tumor control. IV. To assess for changes in patient quality of life with Brief Pain Inventory (BPI) score. V. To assess for adverse event rates. VI. To assess incidence and severity of adverse events/toxicity. VII. To assess technical success for cryoablation. EXPLORATORY OBJECTIVE: I. To investigate the local microenvironmental changes following SBRT and cryoablation combined with SBRT to bone metastases. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients undergo stereotactic body radiation therapy for 1 fraction. ARM B: Patients undergo cryoablation. Within 10 days after cryoablation, patients undergo stereotactic body radiation therapy for 1 fraction. After completion of study treatment, patients are followed up at 1, 2, 3, 4, 8, 12, 16, 20, and 24 weeks.

Conditions

• Castration-Resistant Prostate Carcinoma
• Metastatic Colorectal Carcinoma
• Metastatic Malignant Neoplasm in the Bone
• Metastatic Malignant Solid Neoplasm
• Metastatic Melanoma
• Metastatic Prostate Carcinoma
• Metastatic Renal Cell Carcinoma
• Metastatic Sarcoma
• Metastatic Thyroid Gland Carcinoma
• Metastatic Urothelial Carcinoma
• Stage IV Colorectal Cancer AJCC v8
• Stage IV Prostate Cancer AJCC v8
• Stage IV Renal Cell Cancer AJCC v8
• Stage IVA Colorectal Cancer AJCC v8
• Stage IVA Prostate Cancer AJCC v8
• Stage IVB Colorectal Cancer AJCC v8
• Stage IVB Prostate Cancer AJCC v8
• Stage IVC Colorectal Cancer AJCC v8

Interventions

Type	Name	Description
PROCEDURE	Cryosurgery	Undergo cryoablation
OTHER	Quality-of-Life Assessment	Ancillary studies
RADIATION	Stereotactic Body Radiation Therapy	Undergo stereotactic body radiation therapy

Timeline

• Start date: 2021-03-16
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2021-01-05
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study