Trial Information

PHASE I FEASIBILITY TRIAL OF CRYOSURGICAL ABLATION OF SOFT TISSUE SARCOMAS OF THE EXTREMETY

OBJECTIVES: I. Assess the safety and morbidity associated with cryosurgical ablation in
patients with soft tissue sarcomas of the extremity.

OUTLINE: All patients undergo 1 session of cryoablation. Patients with high-grade sarcoma
receive systemic chemotherapy 10-14 days after cryoablation at the discretion of the
consulting medical oncologist, and undergo surgery 2-3 weeks following chemotherapy.
Patients with low-grade sarcoma and those with high-grade sarcoma who do not receive
chemotherapy undergo surgery 4-6 weeks after cryoablation. Surgery for all patients consists
of en bloc resection or amputation, with limb salvage attempted when feasible. Patients are
followed weekly for 3 weeks.

PROJECTED ACCRUAL: A total of 12 patients (approximately 6 patients with low-grade,
high-risk sarcoma and 6 with high-grade sarcoma) will be entered over approximately 6
months. The study will be suspended for the following: vascular complication that requires
surgical intervention for correction in 2 patients; any neuropraxia that shows no evidence
of resolution after 3 months in 2 patients; any wound complication that requires surgical
correction in 4 patients; or any deep wound infection that requires surgical drainage in 4
patients.