Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002997
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
1999-11-01
Brief Title:
Cryosurgery in Treating Patients With Unresectable Liver Metastases From Colorectal Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Phase II Trial of Cryoablation for Treatment of Unresectable Colorectal Hepatic Metastases
Status:
COMPLETED
Status Verified Date:
2023-06
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 for liver metastases may have fewer side effects and improve recovery
PURPOSE Phase II trial to study the effectiveness of cryosurgery for patients with unresectable liver metastases from colorectal cancer
PURPOSE Phase II trial to study the effectiveness of cryosurgery for patients with unresectable liver metastases from colorectal cancer
Detailed Description:
OBJECTIVES I Evaluate the feasibility of conducting a multi-institutional clinical study of cryosurgery for liver metastases II Evaluate the morbidity and mortality of cryosurgery for liver metastases when applied in a multi-institutional setting III Evaluate the efficacy of cryosurgery for liver metastases as measured by total liver control local lesion control and overall survival
OUTLINE This is a multi-institutional study Patients are first confirmed by exploratory laparotomy to have no extrahepatic metastases They then undergo biopsy of the portal lymph node after which full mobilization of liver is recommended Cholecystectomy is optional but recommended for treatment of tumors adjacent to the gallbladder After mapping out the location and size of the metastatic tumor by ultrasound cryoablation of the metastases is carried out Cryoablation involves the delivery of nitrogen through metallic probes placed surgically into the center of the liver metastases There are two freeze and thaw cycles for each lesion with synchronous intraoperative ultrasound monitoring of the cryoablation One centimeter margin of cryoablation is determined by this ultrasound image Treatment of the liver with regional chemotherapy is not allowed until radiographic and pathologic confirmation of disease progression in the liver Follow-up is at 3 weeks after surgery and then every 3 months
PROJECTED ACCRUAL There will be a maximum of 45 patients accrued in approximately 3 years for this study This is a two stage accrual design in which 17 patients are first accrued of which 15 should be eligible If fewer than 11 of the initial 15 eligible patients show no evidence of disease at 3 months the study stops and treatment is abandoned If at least 11 patients show no evidence of disease then 28 additional patients are accrued
OUTLINE This is a multi-institutional study Patients are first confirmed by exploratory laparotomy to have no extrahepatic metastases They then undergo biopsy of the portal lymph node after which full mobilization of liver is recommended Cholecystectomy is optional but recommended for treatment of tumors adjacent to the gallbladder After mapping out the location and size of the metastatic tumor by ultrasound cryoablation of the metastases is carried out Cryoablation involves the delivery of nitrogen through metallic probes placed surgically into the center of the liver metastases There are two freeze and thaw cycles for each lesion with synchronous intraoperative ultrasound monitoring of the cryoablation One centimeter margin of cryoablation is determined by this ultrasound image Treatment of the liver with regional chemotherapy is not allowed until radiographic and pathologic confirmation of disease progression in the liver Follow-up is at 3 weeks after surgery and then every 3 months
PROJECTED ACCRUAL There will be a maximum of 45 patients accrued in approximately 3 years for this study This is a two stage accrual design in which 17 patients are first accrued of which 15 should be eligible If fewer than 11 of the initial 15 eligible patients show no evidence of disease at 3 months the study stops and treatment is abandoned If at least 11 patients show no evidence of disease then 28 additional patients are accrued
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 |
|---|---|---|---|
| ECOG-1296 | None | None | None |