Study Compares Cryoablation To Radiation Therapy For Pain Relief In Bone Cancer Patients
National Cancer Institute is supporting Endocare's multi-center study comparing the pain-reducing palliative effects of cryoablation and radiation therapy for patients who are experiencing focal pain from cancer that has metastasized to their bones.
The prospective, randomized study, called Cryoablation And Radiation Effectiveness (CARE) for Bone Pain and led by interventional radiologist Matthew Callstrom, M.D., PhD, of Mayo Clinic, will evaluate the efficacy of percutaneous cryoablation compared to external beam radiation therapy (RT) as measured by pain relief, quality of life, analgesic use and complication rates. Dr. Callstrom is also leading another multi-center study on cryoablation of painful metastatic disease.
The trial will be open to patients nationwide through the NCI oncology group network and conducted by the North Central Cancer Treatment Group.
A total of 128 patients are expected to take part in the study. Percutaneous cryoablation is a minimally invasive procedure in which tumors are targeted with ultrasound, computed tomography or magnetic resonance imaging guidance and treated by freezing. This destroys or ablates the tumor. The Endocare Cryocare(R) System will be used to treat all patients in the cryoablation arm of the study. Endocare will also contribute to the funding of the study.
Endocare Chief Executive Officer, President and Chairman Craig T. Davenport noted that the bone is the most common site of metastases, or the spread of cancer, and that many patients do not get adequate pain relief from conventional treatments including chemotherapy, radiation or other drug therapies. There are estimates that more than 100,000 people worldwide suffer from painful bone metastases.
"This is a very important study for Endocare but also for the thousands of patients who are suffering from the spread of cancer to the bone and who have very few viable options to relieve the pain it causes while retaining an active lifestyle," Davenport added. "If the results of the study turn out the way that the early data demonstrate they should, we will have a significant new pain-relieving alternative for cancer patients."
Davenport also noted that Endocare already has clearance from the U.S. Food and Drug Administration to ablate tumors and tissue throughout the body, including this percutaneous cryoablation for palliation of painful metastatic lesions. It is hoped that the study will demonstrate that cryoablation is effective in bone cancer and this could be important to gain positive reimbursement decisions from both government and private payers, Davenport said.