A Phase III Clinical Trial Comparing Oxaliplatin, Capecitabine and Hepatic Arterial Infusion of Floxuridine to Oxaliplatin and Capecitabine in Patients With Resected or Ablated Liver Metastases From Colorectal Cancer
- Compare progression-free interval (PFI) in patients undergoing surgical resection
and/or ablation for hepatic metastases from colorectal cancer treated with adjuvant
therapy comprising oxaliplatin and capecitabine with vs without hepatic arterial
infusion of floxuridine.
- Compare overall survival and liver PFI between the two treatment groups.
- Assess toxicity in each of the treatment regimens.
- Compare self-reported symptoms between two treatment groups.
- Compare quality of life in each of the treatment regimens.
- Examine the prognostic worth, in terms of PFI, of specific molecular markers in hepatic
OUTLINE: This is a randomized study. Patients are stratified according to intended surgical
technique (surgical resection alone vs cryoablation or radiofrequency ablation [RFA] alone
vs combination of resection and ablation) and prior adjuvant chemotherapy regimen
(chemotherapy with vs without oxaliplatin vs no chemotherapy). Patients are randomized to 1
of 2 treatment arms.
All patients undergo surgical resection and/or hepatic cryoablation or RFA to remove a
maximum of 6 colorectal hepatic metastases. Patients randomized to arm II also undergo
intra-arterial catheter and if applicable, pump placement.
- Arm 1 (oxaliplatin and capecitabine): Within 4-6 weeks after surgery and/or ablation,
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 8 courses in the absence of disease
progression or unacceptable toxicity.
- Arm 2 (oxaliplatin, capecitabine, and hepatic arterial infusion of floxuridine): Within
4-6 weeks after surgery and/or ablation, patients receive a continuous hepatic arterial
infusion of floxuridine on days 1-14, oxaliplatin IV over 2 hours on day 22, and oral
capecitabine twice daily on days 22-35. Treatment repeats every 42 days for 4 courses
in the absence of unacceptable toxicity. Beginning with course 5, patients receive
oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14.
Treatment with oxaliplatin and capecitabine repeats every 21 days for 4 courses in the
absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, 4-6 weeks after surgery or ablation, approximately
18 weeks after beginning of chemotherapy, and 4-6 weeks after beginning the last cycle of
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free Interval (PFI)
Time to first recurrence of colon cancer at any site
Time from randomization through year 5
Norman Wolmark, MD
NSABP Foundation, Inc.
United States: Federal Government
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|CCOP - Christiana Care Health Services||Wilmington, Delaware 19899|
|Saint Joseph Mercy Cancer Center||Ann Arbor, Michigan 48106-0995|
|Bronson Methodist Hospital||Kalamazoo, Michigan 49007|
|West Michigan Cancer Center||Kalamazoo, Michigan 49007-3731|
|Borgess Medical Center||Kalamazooaa, Michigan 49001|
|Natalie Warren Bryant Cancer Center at St. Francis Hospital||Tulsa, Oklahoma 74136|
|Geisinger Medical Center||Danville, Pennsylvania 17822-0001|
|University of Wisconsin Paul P. Carbone Comprehensive Cancer Center||Madison, Wisconsin 53792-6164|
|CCOP - Ochsner||New Orleans, Louisiana 70121|
|CCOP - Columbia River Oncology Program||Portland, Oregon 97225|
|City of Hope Comprehensive Cancer Center||Duarte, California 91010|
|Fletcher Allen Health Care - University Health Center Campus||Burlington, Vermont 05401|
|Washington Cancer Institute at Washington Hospital Center||Washington, District of Columbia 20010|
|Central Baptist Hospital||Lexington, Kentucky 40503|
|Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center||Savannah, Georgia 31403-3089|
|Via Christi Cancer Center at Via Christi Regional Medical Center||Wichita, Kansas 67214|
|Wake Forest University Comprehensive Cancer Center||Winston-Salem, North Carolina 27157-1096|
|Mary Babb Randolph Cancer Center at West Virginia University Hospitals||Morgantown, West Virginia 26506|
|Veterans Affairs Medical Center - Loma Linda (Pettis)||Loma Linda, California 92357|
|Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center||Baltimore, Maryland 21237|
|Kaiser Permanente Medical Center - Walnut Creek||Walnut Creek, California 94596|
|John Muir/Mt. Diablo Comprehensive Cancer Center||Walnut Creek, California 94598|
|Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center||Portland, Oregon 97210|
|Providence St. Vincent Medical Center||Portland, Oregon 97225|
|UMC Southwest Cancer and Research Center||Lubbock, Texas 79415-3364|
|Virginia Oncology Associates - Hampton||Hampton, Virginia 23666|
|Altru Cancer Center at Altru Hospital||Grand Forks, North Dakota 58201|
|St. Luke's Cancer Network at St. Luke's Hospital||Bethlehem, Pennsylvania 18015|
|Louisville Oncology at Norton Cancer Center||Louisville, Kentucky 40202|
|Cancer Care Center at John Muir Health - Concord Campus||Concord, California 94524-4110|