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Brief Title: A Study Evaluating Regorafenib Following Completion of Standard Chemotherapy for Patients With Colon Cancer
Official Title: A Phase III Randomized Placebo-Controlled Study Evaluating Regorafenib Following Completion of Standard Chemotherapy for Patients With Stage III Colon Cancer
Study ID: NCT02664077
Brief Summary: This study is a randomized, double-blind, post-chemotherapy, adjuvant phase III clinical trial. The primary aim of this study is to determine the value of regorafenib in improving disease-free survival (DFS). Patients with Stage III (IIIB or IIIC) colon cancer as defined by the 7th Edition of the American Joint Committee on Cancer (AJCC) Cancer Staging Manual are randomized 1:1 to placebo or the experimental agent regorafenib following completion of at least four months of standard adjuvant therapy (e.g., 5-fluorouracil, leucovorin, oxaliplatin (FOLFOX) , capecitabine, oxaliplatin (CapeOx), and other).
Detailed Description: The primary aim of this study is to determine the value of regorafenib in improving DFS. The secondary aims are to evaluate the dose tolerance and long term toxicity of two years of regorafenib following standard adjuvant therapy, and to evaluate the effect of the use of regorafenib in overall survival (OS). Eligible patients in this double-blind study will be randomized to take either regorafenib 120 mg or placebo orally, once daily for 21 consecutive days of a 28 day cycle for 26 cycles (2 years). Accrual for this study will be approximately 1118 randomized patients. These 1118 patients will provide approximately 313 DFS events at the time of primary analysis. An initial futility analysis will be performed when 312 patients have been on study at least 3 months. The decision to continue the trial will be determined by success of both early stopping endpoints defined as follows: * The toxicity profile of regorafenib compared to placebo is acceptable. * The regorafenib regimen is tolerable for prolonged administration. An estimated compliance rate of 60% at 6 months for regorafenib will be required for continuation of the study. If toxicity is acceptable and compliance with regorafenib is at least 60% nominally, then accrual will continue. The second futility analysis will be conducted when approximately 67 DFS events are observed. Trial conduct and accrual will continue unless the primary endpoint (DFS) trends too far in the opposite direction (hazard ratio greater than or equal to 1.1). Toxicity will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. NSABP C-13 will include a Behavioral and Health Outcomes correlative science component. A C-13 Quality of Life (QOL) questionnaire will be administered at baseline (after consent and prior to randomization) and at 3 months, 6 months, 12 months, 18 months, 24 months, and 30 months. Submission of blood samples for C-13 correlative science studies will be a study requirement for all patients. Submissions will also include archived primary tumor tissue from the resected colon primary. Blood samples for pharmacokinetics (PK) will be collected on Day 15 of Cycle 1 and Day 15 of Cycle 2, with additional blood samples for biomarkers collected at various time points for future analysis.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
St. Joseph Hospital of Orange, Orange, California, United States
St. Joseph Heritage Healthcare, Santa Rosa, California, United States
Kaiser Permanente Medical Center - Vallejo, Vallejo, California, United States
Colorado Cancer Research Program, Denver, Colorado, United States
Yale University, New Haven, Connecticut, United States
University of Florida, Gainesville, Florida, United States
Mount Sinai Comprehensive Cancer Center, Miami Beach, Florida, United States
Memorial Health University Medical Center, Savannah, Georgia, United States
Cancer Care Specialists of Illinois - Decatur Memorial Hospital, Decatur, Illinois, United States
Edward Hospital Cancer Center, Naperville, Illinois, United States
Carle Cancer Center, Urbana, Illinois, United States
Northern Indiana Cancer Research Consortium, South Bend, Indiana, United States
Oncology Associates at Mercy Medical Center, Cedar Rapids, Iowa, United States
Genesis Medical Center - West Campus, Davenport, Iowa, United States
University of Iowa, Iowa City, Iowa, United States
Covenant Cancer Treatment Center, Waterloo, Iowa, United States
Norton Cancer Institute, Norton Healthcare Pavilion, Louisville, Kentucky, United States
Tulane University Health Sciences Center, New Orleans, Louisiana, United States
New England Cancer Specialists, Scarborough, Maine, United States
Berkshire Medical Center Cancer and Infusion Center, Pittsfield, Massachusetts, United States
Breslin Cancer Center, Lansing, Michigan, United States
Metro Minnesota Community Oncology Research Consortium, Saint Louis Park, Minnesota, United States
Missouri Valley Cancer Consortium, Omaha, Nebraska, United States
Nevada Cancer Research Foundation, Inc., Las Vegas, Nevada, United States
MD Anderson Cancer Center at Cooper, Camden, New Jersey, United States
Monmouth Medical Center, Long Branch, New Jersey, United States
Newark Beth Israel Medical Center, Newark, New Jersey, United States
Community Medical Center, Toms River, New Jersey, United States
Waverly Hematology Oncology, Cary, North Carolina, United States
CaroMont Regional Medical Center, Gastonia, North Carolina, United States
Margaret R. Pardee Memorial Hospital, Hendersonville, North Carolina, United States
First Health of the Carolinas Cancer Center, Pinehurst, North Carolina, United States
Wake Forest Baptist Health, Winston-Salem, North Carolina, United States
James Cancer Hospital and Solove Research Institute at the Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Toledo Clinic Cancer Center, Toledo, Ohio, United States
Abington Hospital -Jefferson South, Abington, Pennsylvania, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
Allegheny General Hospital, Pittsburgh, Pennsylvania, United States
UPMC Cancer Centers, Pittsburgh, Pennsylvania, United States
Guthrie Medical Group, PC, Sayre, Pennsylvania, United States
Scranton Hematology Oncology, Scranton, Pennsylvania, United States
Reading Hospital - McGlinn Cancer Institute, West Reading, Pennsylvania, United States
AnMed Health Cancer Center, Anderson, South Carolina, United States
McLeod Cancer Center for Treatment and Research, Florence, South Carolina, United States
Wellmont Medical Associates Oncology and Hematology, Kingsport, Tennessee, United States
Thompson Cancer Survival Center, Knoxville, Tennessee, United States
Joe Arrington Cancer Research and Treatment Center, Lubbock, Texas, United States
Virginia Commonwealth University, Richmond, Virginia, United States
West Virginia University, Morgantown, West Virginia, United States
Green Bay Oncology, Ltd. - St. Vincent Hospital, Green Bay, Wisconsin, United States
Name: Norman Wolmark, MD
Affiliation: NSABP Foundation
Role: PRINCIPAL_INVESTIGATOR