Cryosurgery in Treating Patients With Soft Tissue Sarcoma
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.
Procedure: conventional surgery
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||PHASE I FEASIBILITY TRIAL OF CRYOSURGICAL ABLATION OF SOFT TISSUE SARCOMAS OF THE EXTREMETY|
|Study Start Date:||June 1996|
|Study Completion Date:||July 2000|
|Primary Completion Date:||July 2000 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002863
|United States, California|
|USC/Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033-0800|
|Study Chair:||Lawrence Menendez, MD||University of Southern California|