Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030563
Status:
COMPLETED
Last Update Posted:
2017-04-17
First Post:
2002-02-14
Brief Title:
Surgery With or Without Radiofrequency Ablation Followed by Irinotecan in Treating Patients With Colorectal Cancer That is Metastatic to the Liver
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
A Phase II Study Of Adjuvant Intravenous Irinotecan Following Resection With Or Without Radiofrequency Ablation RFA Of Hepatic Metastases From Colorectal Carcinoma
Status:
COMPLETED
Status Verified Date:
2017-04
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 Radiofrequency ablation uses high-frequency electric current to kill tumor cells Combining radiofrequency ablation with surgery may kill more tumor cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Giving a chemotherapy drug after surgery and radiofrequency ablation may kill any remaining tumor cells
PURPOSE Phase II trial to determine the effectiveness of surgery with or without radiofrequency ablation followed by irinotecan in treating patients who have colorectal cancer that is metastatic to the liver
PURPOSE Phase II trial to determine the effectiveness of surgery with or without radiofrequency ablation followed by irinotecan in treating patients who have colorectal cancer that is metastatic to the liver
Detailed Description:
OBJECTIVES
Determine the disease-free survival in patients with hepatic metastases from primary colorectal carcinoma treated with surgical resection with or without radiofrequency ablation followed by irinotecan
Determine the overall survival in patients treated with this regimen
Determine the treatment-related toxicity of this regimen in these patients
Correlate the measurement of molecular markers with clinical outcome in patients treated with this regimen
OUTLINE This is a multicenter study Patients are stratified according to treatment with radiofrequency ablation in addition to resection yes vs no
Patients undergo surgical resection with or without radiofrequency ablation Beginning 4-8 weeks after surgery patients receive irinotecan IV over 90 minutes on day 1 Chemotherapy repeats every 3 weeks for a total of 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed at 4 weeks every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 70 patients will be accrued for this study
Determine the disease-free survival in patients with hepatic metastases from primary colorectal carcinoma treated with surgical resection with or without radiofrequency ablation followed by irinotecan
Determine the overall survival in patients treated with this regimen
Determine the treatment-related toxicity of this regimen in these patients
Correlate the measurement of molecular markers with clinical outcome in patients treated with this regimen
OUTLINE This is a multicenter study Patients are stratified according to treatment with radiofrequency ablation in addition to resection yes vs no
Patients undergo surgical resection with or without radiofrequency ablation Beginning 4-8 weeks after surgery patients receive irinotecan IV over 90 minutes on day 1 Chemotherapy repeats every 3 weeks for a total of 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed at 4 weeks every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 70 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 |
|---|---|---|---|
| CWRU-UWMC-1200 | None | None | None |
| UWASH-1200 | None | None | None |
| CWRU-040106 | None | None | None |
| UWASH-440E-ONC-0020-250 | None | None | None |
| NCI-G01-2045 | None | None | None |