Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002863
Status:
TERMINATED
Last Update Posted:
2014-05-22
First Post:
1999-11-01
Brief Title:
Cryosurgery in Treating Patients With Soft Tissue Sarcoma
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
PHASE I FEASIBILITY TRIAL OF CRYOSURGICAL ABLATION OF SOFT TISSUE SARCOMAS OF THE EXTREMETY
Status:
TERMINATED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient Accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
PURPOSE Phase I trial to study the effectiveness of cryosurgery with or without chemotherapy in treating patients who have soft tissue sarcoma
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V96-1059 | None | None | None |
| LAC-USC-11S-96-1 | None | None | None |