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Spots Global Cancer Trial Database for A Study Evaluating Regorafenib Following Completion of Standard Chemotherapy for Patients With Colon Cancer

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Trial Identification

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

Interventions

Regorafenib
Placebo

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Norman Wolmark, MD

Affiliation: NSABP Foundation

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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