A Phase III Randomized Trial of Cryoablation vs. Radiation for the Palliation of Painful Bone Metastases
- To determine pain relief in cancer patients with painful metastatic disease involving
bone following treatment with cryoablation as compared to radiotherapy (RT).
- To compare the impact on quality-of-life following cryoablation or RT in patients with
painful metastatic disease as measured using the validated Brief Pain Inventory (BPI)
and Short Form (SF)-8.
- To determine change in analgesic use following therapy.
- To determine the frequency and severity of complications following treatment of painful
metastases involving bone with either cryoablation or RT.
OUTLINE: This is a multicenter study. Patients are stratified according to size of the
indexing lesion (≤ 5 cm vs > 5 cm), location of the target lesion (pelvis vs extremity vs
vertebral body vs other), primary cancer type (melanoma or renal cell carcinoma vs other),
and severity of pain (i.e., worst pain score in the last 24-hour period) (4-6 vs 7-10).
Patients are randomized to 1 of 2 treatment arms.
- Arm I (percutaneous cryoablation): Cryoprobes are inserted percutaneously under CT scan
or ultrasound guidance, to the malignant soft tissue-bone interface. Patients undergo
ablations using a freeze-thaw-freeze cycle lasting approximately 10-5-10 minutes,
- Arm II (external-beam radiotherapy): Patients undergo external-beam radiotherapy
comprising either a single 8 Gy dose or 20 Gy/5 fractions administered over 1 week.
Patients are contacted via phone on days 1 and 4 post treatment, weekly in weeks 1-4, every
2 weeks in weeks 6-24, and then every four weeks in weeks 28-36. Patients undergo pain and
pain interference with daily life assessment at baseline and at these time points. Patients
who elect to have repeated treatment (either radiotherapy or cryoablation) within the first
6 weeks after the initial treatment are removed from the study. Patients who fail to achieve
a 2-point reduction in worst or average pain (in a 24-hour period) during weeks 6-20 after
initial treatment and patients who report a return of pain (i.e., pain ≥ the worst pain in a
24-hour period reported at baseline) for 2 consecutive time points are offered the
alternative treatment (radiotherapy or cryoablation, whichever the patient was not
randomized to receive at initial treatment)*.
NOTE: *Patients who refuse to receive the alternative treatment are taken off study.
Allocation: Randomized, Primary Purpose: Treatment
Comparison of pre- and post-treatment worst pain in 24 hours at week 6 as measured on the numeric 0 to 10 Brief Pain Inventory (BPI) scale
Matthew R. Callstrom, MD, PhD
United States: Federal Government
|Mayo Clinic Scottsdale||Scottsdale, Arizona 85259|
|Mayo Clinic - Jacksonville||Jacksonville, Florida 32224|
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|
|Medical College of Wisconsin Cancer Center||Milwaukee, Wisconsin 53226|
|Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center||Milwaukee, Wisconsin 53201-2901|
|UAB Comprehensive Cancer Center||Birmingham, Alabama 35294|