Spots Global Cancer Trial Database for S9415 Chemotherapy in Patients With Stage II or III Colon Cancer That Has Been Surgically Removed
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Trial Identification
Brief Title: S9415 Chemotherapy in Patients With Stage II or III Colon Cancer That Has Been Surgically Removed
Official Title: Phase III Randomized Trial of 5-FU/Leucovorin/Levamisole Versus 5-FU Continuous Infusion/Levamisole as Adjuvant Therapy for High-Risk Resectable Colon Cancer
Study ID: NCT00002593
Conditions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving drugs in different ways may kill more cancer cells. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy given in different ways in treating patients with surgically removed stage II or stage III colon cancer at high risk of recurrence.
Detailed Description: OBJECTIVES: I. Compare overall and disease free survival in patients with completely resected stage II or III colon cancer randomized to adjuvant chemotherapy with bolus fluorouracil and leucovorin calcium with levamisole vs continuous infusion fluorouracil with levamisole. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, T stage (T1 vs T2 vs T3 vs T4a), N stage (N0 vs N1 vs N2-3), and time from surgery until registration (21-28 vs 29-35 days). Patients are randomized to one of two treatment arms. Arm I: Patients receive leucovorin calcium IV immediately followed by fluorouracil IV on days 1 through 5 of weeks 1, 5, 9, 14, 19, and 24, and oral levamisole 3 times a day for 3 days on days 1-3. Courses repeat every 2 weeks for 6 months. Arm II: Patients receive levamisole as in arm I plus fluorouracil by continuous IV infusion for 8 weeks. Treatment with fluorouracil repeats every 10 weeks for 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed at 9 months and 12 months, then every 6 months for 4 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 1,500 patients will be accrued for the study over approximately 5.5 years.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
CCOP - Scottsdale Oncology Program, Scottsdale, Arizona, United States
Veterans Affairs Medical Center - Palo Alto, Palo Alto, California, United States
UCSF Cancer Center and Cancer Research Institute, San Francisco, California, United States
Stanford University Medical Center, Stanford, California, United States
CCOP - Colorado Cancer Research Program, Inc., Denver, Colorado, United States
Walter Reed Army Medical Center, Washington, District of Columbia, United States
Sylvester Cancer Center, University of Miami, Miami, Florida, United States
Emory University Hospital - Atlanta, Atlanta, Georgia, United States
Veterans Affairs Medical Center - Atlanta (Decatur), Decatur, Georgia, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois, United States
Veterans Affairs Medical Center - Chicago (Lakeside), Chicago, Illinois, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
CCOP - Illinois Oncology Research Association, Peoria, Illinois, United States
CCOP - Carle Cancer Center, Urbana, Illinois, United States
CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa, United States
CCOP - Iowa Oncology Research Association, Des Moines, Iowa, United States
Siouxland Hematology-Oncology, Sioux City, Iowa, United States
CCOP - Ochsner, New Orleans, Louisiana, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center, Worcester, Massachusetts, United States
CCOP - Kalamazoo, Kalamazoo, Michigan, United States
CCOP - Duluth, Duluth, Minnesota, United States
University of Minnesota Cancer Center, Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
CentraCare Clinic, Saint Cloud, Minnesota, United States
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States
Barnes-Jewish Hospital, Saint Louis, Missouri, United States
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, United States
CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, United States
Veterans Affairs Medical Center - Albany, Albany, New York, United States
Albert Einstein Comprehensive Cancer Center, Bronx, New York, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
North Shore University Hospital, Manhasset, New York, United States
Mount Sinai Medical Center, NY, New York, New York, United States
University of Rochester Cancer Center, Rochester, New York, United States
State University of New York - Upstate Medical University, Syracuse, New York, United States
Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, North Carolina, United States
CCOP - Southeast Cancer Control Consortium, Winston-Salem, North Carolina, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina, United States
Quain & Ramstad Clinic, P.C., Bismarck, North Dakota, United States
Altru Health Systems, Grand Forks, North Dakota, United States
Ireland Cancer Center, Cleveland, Ohio, United States
CCOP - Toledo Community Hospital Oncology Program, Toledo, Ohio, United States
CCOP - Geisinger Clinical and Medical Center, Danville, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States
Rhode Island Hospital, Providence, Rhode Island, United States
Rapid City Regional Hospital, Rapid City, South Dakota, United States
CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota, United States
University of Tennessee, Memphis Cancer Center, Memphis, Tennessee, United States
Vermont Cancer Center, Burlington, Vermont, United States
Veterans Affairs Medical Center - Madison, Madison, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, United States
CCOP - Marshfield Medical Research and Education Foundation, Marshfield, Wisconsin, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki), Milwaukee, Wisconsin, United States
Saskatchewan Cancer Agency, Regina, Saskatchewan, Canada
Veterans Affairs Medical Center - San Juan, San Juan, , Puerto Rico
Pretoria Academic Hospital, Pretoria, , South Africa
Contact Details
Name: Elizabeth A. Poplin, MD
Affiliation: Rutgers Cancer Institute of New Jersey
Role: STUDY_CHAIR
Name: Robert J. Mayer, MD, FACP
Affiliation: Dana-Farber Cancer Institute
Role: STUDY_CHAIR
Name: Daniel G. Haller, MD
Affiliation: Abramson Cancer Center at Penn Medicine
Role: STUDY_CHAIR
Name: Richard M. Goldberg, MD
Affiliation: Mayo Clinic
Role: STUDY_CHAIR
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