Cryoablation Combined With Stereotactic Body Radiation Therapy for the Treatment of Painful Bone Metastases, the CROME Trial
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Metastatic Malignant Neoplasm in the Bone
- Castration-Resistant Prostate Carcinoma
- Stage IV Renal Cell Cancer AJCC v8
- Stage IV Prostate Cancer AJCC v8
- Stage IVA Colorectal Cancer AJCC v8
- Metastatic Colorectal Carcinoma
- Metastatic Malignant Solid Neoplasm
- Metastatic Melanoma
- Metastatic Prostate Carcinoma
- Metastatic Renal Cell Carcinoma
- Metastatic Sarcoma
- Metastatic Thyroid Gland Carcinoma
- Stage IVB Colorectal Cancer AJCC v8
- Metastatic Urothelial Carcinoma
- Stage IVA Prostate Cancer AJCC v8
- Stage IVB Prostate Cancer AJCC v8
- Stage IVC Colorectal Cancer AJCC v8
- Stage IV Colorectal Cancer AJCC v8
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 dura...
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.
Tracking Information
- NCT #
- NCT04693377
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Rahul A Sheth M.D. Anderson Cancer Center
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