Sarcoma Clinical Trial
Official title:
PHASE I FEASIBILITY TRIAL OF CRYOSURGICAL ABLATION OF SOFT TISSUE SARCOMAS OF THE EXTREMETY
RATIONALE: Cryosurgery kills cancer cells by freezing them. Drugs used in chemotherapy use
different ways to stop tumor cells from dividing so they stop growing or die. Combining
cryosurgery with chemotherapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of cryosurgery with or without
chemotherapy in treating patients who have soft tissue sarcoma.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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