Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002655
Status:
COMPLETED
Last Update Posted:
2013-07-22
First Post:
1999-11-01
Brief Title:
Cryosurgery in Treating Patients With Liver Cancer or Liver Metastases
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Cryosurgical Destruction of Surgically Incurable Liver Tumors
Status:
COMPLETED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
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 during surgery
PURPOSE Phase III trial to study the effectiveness of cryosurgery in treating patients with unresectable primary liver cancer or liver metastases
PURPOSE Phase III trial to study the effectiveness of cryosurgery in treating patients with unresectable primary liver cancer or liver metastases
Detailed Description:
OBJECTIVES I Assess the safety and efficacy of liquid nitrogen necrosis of liver lesions using a commercially available intraoperative cryosurgical system with placement of the cryoprobe and subsequent monitoring by high-resolution ultrasound II Use this technique on selected patients with surgically unresectable metastatic or primary liver cancer whose disease appears confined to the liver and who are potentially curable if all tumor in the liver can be destroyed III Quantitate the quality and duration of survival identify recurrence of hepatic malignant disease and identify any morbidity from the procedure
OUTLINE Cryosurgery Liquid nitrogen freezing of tumor using a cryoprobe placed and maintained under ultrasound guidance
PROJECTED ACCRUAL 50 patients will be treated
OUTLINE Cryosurgery Liquid nitrogen freezing of tumor using a cryoprobe placed and maintained under ultrasound guidance
PROJECTED ACCRUAL 50 patients will be treated
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-V95-0657 | OTHER_GRANT | National Cancer Institute | None |