Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00070265
Status:
TERMINATED
Last Update Posted:
2013-01-24
First Post:
2003-10-03
Brief Title:
Neoadjuvant and Adjuvant Capecitabine and Oxaliplatin in Treating Patients With Resectable Liver Metastases Secondary to Colorectal Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Multi-Institutional Phase II Trial Of Neoadjuvant Capecitabine XELODA And Oxaliplatin ELOXATIN For Resectable Colorectal Metastases In The Liver
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administratively complete
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Drugs used in chemotherapy such as capecitabine and oxaliplatin use different ways to stop tumor cells from dividing so they stop growing or die Giving capecitabine and oxaliplatin before surgery may shrink the tumor so that it can be removed Giving capecitabine and oxaliplatin after surgery may kill any remaining tumor cells This phase II trial is studying how well capecitabine and oxaliplatin work when given before and after surgery in treating patients with resectable liver metastases that is secondary to colorectal cancer
Detailed Description:
PRIMARY OBJECTIVES
I Determine the efficacy and toxicity of neoadjuvant and adjuvant capecitabine and oxaliplatin in patients with resectable liver metastases secondary to colorectal cancer who are undergoing surgery
II Determine the rates of R0 resection in patients treated with this regimen before surgery
SECONDARY OBJECTIVES
I Determine the response rate in patients treated with this regimen II Determine the resectability in the subsets of patients defined as resectable preoperatively and treated with this regimen
III Determine improvement in survival associated with downstaging based on metastatic colorectal prognostic score in patients treated with this regimen
IV Determine the disease-free and overall survival of patients treated with this regimen
V Correlate drug-specific biomarkers with clinical response in patients treated with this regimen
OUTLINE This is a multicenter study
Neoadjuvant chemotherapy Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14 Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity
Surgery Four to six weeks after the completion of chemotherapy patients undergo surgical resection of the tumor
Adjuvant chemotherapy Patients with satisfactory response to therapy receive 4 additional courses of oxaliplatin and capecitabine after surgery
Patients are followed at 4-6 weeks after surgery every 3 months for 2 years every 4 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A maximum of 80 patients will be accrued for this study
I Determine the efficacy and toxicity of neoadjuvant and adjuvant capecitabine and oxaliplatin in patients with resectable liver metastases secondary to colorectal cancer who are undergoing surgery
II Determine the rates of R0 resection in patients treated with this regimen before surgery
SECONDARY OBJECTIVES
I Determine the response rate in patients treated with this regimen II Determine the resectability in the subsets of patients defined as resectable preoperatively and treated with this regimen
III Determine improvement in survival associated with downstaging based on metastatic colorectal prognostic score in patients treated with this regimen
IV Determine the disease-free and overall survival of patients treated with this regimen
V Correlate drug-specific biomarkers with clinical response in patients treated with this regimen
OUTLINE This is a multicenter study
Neoadjuvant chemotherapy Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14 Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity
Surgery Four to six weeks after the completion of chemotherapy patients undergo surgical resection of the tumor
Adjuvant chemotherapy Patients with satisfactory response to therapy receive 4 additional courses of oxaliplatin and capecitabine after surgery
Patients are followed at 4-6 weeks after surgery every 3 months for 2 years every 4 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A maximum of 80 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 |
|---|---|---|---|
| CDR0000331853 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchN01CM17003 |
| MDA-ID-02636 | None | None | None |
| N01CM17003 | NIH | None | None |