A Phase II Study to Determine the Surgical Conversion Rate in Patients Receiving Neoadjuvant mFOLFOX7 + Cetuximab for Unresectable Wild-Type K-RAS Colorectal Cancer With Metastases Confined to the Liver
All patients will receive the FC-6 study treatment regimen every 2 weeks during each 8-week
cycle for a total of 3 cycles.
Baseline imaging of the chest, abdomen, and pelvis will be performed. CT scan or MRI of the
abdomen will be performed after 1 cycle of neoadjuvant therapy to assess clinical response
and resectability of liver metastases. If liver metastases are not deemed to be resectable
at this assessment, but tumor assessment demonstrates stable disease or partial response,
therapy will continue with re-assessment for clinical response and resectability after Cycle
2 and, if necessary, after Cycle 3.
After a minimum of 1 cycle of therapy, patients who meet the guidelines for resection of
liver metastases will undergo liver metastasectomy (tumor resection and/or ablation) as soon
as judged technically feasible by the hepatic surgeon in order to minimize chemotherapy
damage to the liver and morbidity from surgery. At the investigator's discretion, the
chemotherapy and cetuximab regimen may be continued for 1 additional treatment given at
least 2 weeks before the planned date of surgery. This additional treatment, if given, will
not be considered to be part of the 3 study therapy cycles.
The surgical goal is to perform a curative (R0) resection and/or ablation. If curative
surgery was performed and if only 1 or 2 cycles of therapy were administered before surgery,
postoperative therapy using the same regimen will resume 4-6 weeks following surgery to
complete 3 cycles of study treatment. Following discontinuation of study therapy, all
patients who undergo R0 resection (with or without ablation) will be followed every 3 months
for the first 2 years on the study and then every 6 months for years 3 through 5.
Further therapy for patients who do not undergo R0 resection/ablation will be at the
investigator's discretion. These patients will only be followed for vital status every 12
months for the remainder of the 5-year period following study entry.
A total sample size of 60 patients will be enrolled in the FC-6 trial.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The percentage of patients who had a curative (R0) liver metastasectomy following protocol treatment, i.e., metastatic disease that can be completely resected and/or ablated with no postoperative evidence of residual malignant disease (R0 resection).
Norman Wolmark, MD
NSABP Foundation, Inc.
United States: Institutional Review Board
|University of Iowa||Iowa City, Iowa 52242|
|CCOP - Upstate Carolina||Spartanburg, South Carolina 29303|
|CCOP - Christiana Care Health Services||Wilmington, Delaware 19899|
|CCOP - Metro-Minnesota||Saint Louis Park, Minnesota 55416|
|Medical College of Wisconsin||Milwaukee, Wisconsin 53226|
|Loma Linda University Medical Center||Loma Linda, California 92354|
|CCOP - Grand Rapids Clinical Oncology Program||Grand Rapids, Michigan 49503|
|Kaiser Permanente Medical Center - Vallejo||Vallejo, California 94589|
|Franklin Square Hospital Center||Baltimore, Maryland 21237|
|Vermont Cancer Center at University of Vermont||Burlington, Vermont 05405-0075|
|M.D. Anderson Cancer Center - Orlando||Orlando, Florida 32806|
|Allegheny Cancer Center at Allegheny General Hospital||Pittsburgh, Pennsylvania 15212|
|University of Pittsburgh||Pittsburgh, Pennsylvania 15261|
|Henry Ford Health System||Detroit, Michigan 48202|
|Thomas Jefferson University Hospital||Philadelphia, Pennsylvania 19131|
|Edward Hospital||Naperville, Illinois 60566|
|NSABP Foundation, Inc.||Pittsburgh, Pennsylvania 15212|
|Kaiser Permanente-San Diego||San Diego, California 92120|
|CCOP, Dayton, OH||Dayton, Ohio 45429|
|St. Joseph Hospital||Orange, California 92868|
|CCOP, William Beaumont Hospital||Royal Oak, Michigan 48073|
|CCOP - NorthShore University HealthSystem||Evanston, Illinois 60201|
|NortonHealthcare, Inc.||Louisville, Kentucky 40202-5070|