Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004136
Status:
COMPLETED
Last Update Posted:
2018-11-06
First Post:
1999-12-10
Brief Title:
Heat Therapy in Treating Patients With Unresectable Primary or Metastatic Liver Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase II Study of Radiofrequency Ablation of Unresectable Liver Tumors
Status:
COMPLETED
Status Verified Date:
2018-11
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 Heating tumors to several degrees above body temperature may kill tumor cells
PURPOSE Phase II trial to study the effectiveness of heat therapy in treating patients who have unresectable primary or metastatic liver cancer
PURPOSE Phase II trial to study the effectiveness of heat therapy in treating patients who have unresectable primary or metastatic liver cancer
Detailed Description:
OBJECTIVES I Determine the efficacy of radiofrequency ablation in patients with primary or metastatic liver cancer II Determine disease free survival local recurrence rate in treated lesions as compared to known recurrence rates after hepatic cryoablation and overall survival in this patient population receiving this regimen
OUTLINE Patients undergo laparoscopic or open laparotomy surgical procedure to identify unresectable tumors by ultrasound Tumors are heated to a target temperature by electrodes for a maximum of 20 minutes To achieve a 1 cm margin of ablated tissue around each lesion multiple ablation courses may be performed depending on the size of the lesions and the time required to complete the treatment Patients may be retreated if tumor recurs or new disease appears Patients are followed at 1 month every 3 months for the first 2 years every 6 months for next 3 years and then annually thereafter
PROJECTED ACCRUAL A maximum of 59 patients will be accrued for this study
OUTLINE Patients undergo laparoscopic or open laparotomy surgical procedure to identify unresectable tumors by ultrasound Tumors are heated to a target temperature by electrodes for a maximum of 20 minutes To achieve a 1 cm margin of ablated tissue around each lesion multiple ablation courses may be performed depending on the size of the lesions and the time required to complete the treatment Patients may be retreated if tumor recurs or new disease appears Patients are followed at 1 month every 3 months for the first 2 years every 6 months for next 3 years and then annually thereafter
PROJECTED ACCRUAL A maximum of 59 patients will be accrued for this study
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 |
|---|---|---|---|
| P30CA016672 | NIH | None | None |
| MDA-ID-97328 | OTHER | None | None |
| NCI-G99-1613 | None | None | None |
| CDR0000067366 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA016672 |