Clinical Trials Logo
  1. Home
  2. Liver Metastases
  3. NCT00070265

Neoadjuvant and Adjuvant Capecitabine and Oxaliplatin in Treating Patients With Resectable Liver Metastases Secondary to Colorectal Cancer

Liver Metastases Clinical Trial

Official title:
A Multi-Institutional Phase II Trial Of Neoadjuvant Capecitabine (XELODA) And Oxaliplatin (ELOXATIN) For Resectable Colorectal Metastases In The Liver

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00070265
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Terminated
Phase Phase 2
Start date August 2003
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03781934 - A Study to Evaluate MIV-818 in Patients With Liver Cancer Manifestations Phase 1/Phase 2
Recruiting NCT05057052 - Cryoablation Combined With Sintilimab Plus Regorafenib In Previously Treated Colorectal Cancer Liver Metastasis Phase 2
Recruiting NCT06120127 - Postoperative Chemotherapy With/Without Radiotherapy and Immunotherapy for Colorectal Liver Metastases With High Risk of Locally Recurrence Phase 2
Recruiting NCT04837885 - Intra-arterial Hepatic (IAH) Infusion of Radiolabelled Somatostatin Analogs in GEP-NET Patients With Dominant Liver Metastases Phase 2
Terminated NCT04589884 - Intraoperative EXamination Using MAChine-learning-based HYperspectral for diagNosis & Autonomous Anatomy Assessment
Not yet recruiting NCT04520737 - Multimodal Prehabilitation During Chemotherapy in Patients With Colorectal Liver Metastases N/A
Terminated NCT02465112 - Metabolic Radiotherapy After Complete Resection of Liver Metastases in Patient With Digestive Neuroendocrine Tumor Phase 3
Completed NCT02352259 - Treatment of Liver Metastases With Electrochemotherapy (ECTJ) Phase II Phase 2
Active, not recruiting NCT01763450 - Bevacizumab Therapy Untreated Unresectable Liver Metastases From Colorectal Cancer Phase 2
Withdrawn NCT01631539 - Chemoembolisation With CPT11 Loaded DC Bead With Cetuximab and 5FU/LV in First Line in Patients With KRAS Wildtype mCRC N/A
Recruiting NCT01250158 - Liver-PILP First-in-Man N/A
Terminated NCT01233544 - Radiofrequency Ablation Versus Stereotactic Radiotherapy in Colorectal Liver Metastases Phase 3
Completed NCT01347333 - Stereotactic Body Radiotherapy for Liver Tumors N/A
Completed NCT01683357 - Prognosis of One-stage Hepatectomy for Bilobar Colorectal Metastases N/A
Completed NCT00587756 - Alternative to Two-Stage Hepatectomy N/A
Completed NCT04942665 - Low Dose ICG for Biliary Tract and Tumor Imaging Phase 2
Not yet recruiting NCT05354674 - Multimodal Deep Learning Signature for Evaluation of Response to Bevacizumab in Patient With Colorectal Cancer Liver Metastasis
Recruiting NCT04616495 - Liver Transplantation in Patients With Unresectable Colorectal Liver Metastases
Not yet recruiting NCT04509635 - Cetuximab Re-challenge for Colorectal Cancer Liver Metastasis Phase 3
Recruiting NCT04178759 - Impact of Chemotherapy and Regenerative Markers of Liver Regeneration After Liver Resection for Liver Metastases N/A