A PHASE III PROSPECTIVE RANDOMIZED STUDY OF ADJUVANT CHEMOTHERAPY WITH VINORELBINE AND CISPLATIN IN COMPLETELY RESECTED NON-SMALL CELL LUNG CANCER WITH COMPANION TUMOUR MARKER EVALUATION
OBJECTIVES: I. Compare the duration of overall and disease-free survival in patients with
completely resected non-small cell lung cancer (NSCLC) randomized to adjuvant chemotherapy
with vinorelbine and cisplatin versus observation only. II. Confirm the prognostic
significance of ras mutations when present in the primary tumor. III. Provide a
comprehensive tumor bank linked to a clinical database for the further study of molecular
markers in resected NSCLC. IV. Measure and compare the health-related quality of life of
patients on both treatment arms. V. Evaluate any toxicity related to this treatment regimen.
OUTLINE: This is a randomized study. Patients are stratified according to participating
institution, nodal status (N0 vs N1), and ras mutation status of primary tumor (absent vs
present vs unknown). Patients are randomized to one of two treatment arms. Arm I: Patients
are evaluated at 3 and 6 months after randomization. Arm II: Patients receive vinorelbine IV
over 6-10 minutes weekly for 16 weeks. Patients also receive cisplatin IV on days 1 and 8
every 4 weeks for a total of 4 courses. Treatment continues in the absence of disease
progression or unacceptable toxicity. Quality of life is assessed at Canadian centers.
Quality of life assessments are optional for ECOG and SWOG centers. Patients are followed
every 3 months for 2 years and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study within 6.75 years.
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
survival
At time of death
No
Timothy L. Winton, MD
Study Chair
University of Alberta
United States: Federal Government
BR10
NCT00002583
July 1994
December 2009
Name | Location |
---|---|
Arizona Cancer Center | Tucson, Arizona 85724 |
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
USC/Norris Comprehensive Cancer Center | Los Angeles, California 90033-0800 |
Chao Family Comprehensive Cancer Center | Orange, California 92868 |
University of Colorado Cancer Center | Denver, Colorado 80262 |
Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
University of Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
Albert B. Chandler Medical Center, University of Kentucky | Lexington, Kentucky 40536-0084 |
University of Massachusetts Memorial Medical Center | Worcester, Massachusetts 01655 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina 27599-7295 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center | Winston-Salem, North Carolina 27157-1082 |
Barrett Cancer Center, The University Hospital | Cincinnati, Ohio 45219 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
Simmons Cancer Center - Dallas | Dallas, Texas 75235-9154 |
University of Washington Medical Center | Seattle, Washington 98195-6043 |
University of California Davis Medical Center | Sacramento, California 95817 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
MBCCOP - LSU Medical Center | New Orleans, Louisiana 70112 |
Rhode Island Hospital | Providence, Rhode Island 02903 |
University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
CCOP - Greater Phoenix | Phoenix, Arizona 85006-2726 |
CCOP - Atlanta Regional | Atlanta, Georgia 30342-1701 |
CCOP - Kansas City | Kansas City, Missouri 64131 |
CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
University of California San Diego Cancer Center | La Jolla, California 92093-0658 |
UCSF Cancer Center and Cancer Research Institute | San Francisco, California 94115-0128 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
Marlene & Stewart Greenebaum Cancer Center, University of Maryland | Baltimore, Maryland 21201 |
Ellis Fischel Cancer Center - Columbia | Columbia, Missouri 65203 |
Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
Norris Cotton Cancer Center | Lebanon, New Hampshire 03756 |
CCOP - North Shore University Hospital | Manhasset, New York 11030 |
State University of New York - Upstate Medical University | Syracuse, New York 13210 |
CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
University of Tennessee, Memphis Cancer Center | Memphis, Tennessee 38103 |
MBCCOP - Massey Cancer Center | Richmond, Virginia 23298-0037 |
Mount Sinai Medical Center, NY | New York, New York 10029 |
Loyola University Medical Center | Maywood, Illinois 60153 |
New York Presbyterian Hospital - Cornell Campus | New York, New York 10021 |
Morristown Memorial Hospital | Morristown, New Jersey 07962-1956 |
Henry Ford Hospital | Detroit, Michigan 48202 |
Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
Veterans Affairs Medical Center - Birmingham | Birmingham, Alabama 35233 |
MBCCOP - University of South Alabama | Mobile, Alabama 36688 |
Veterans Affairs Medical Center - Long Beach | Long Beach, California 90822 |
Beckman Research Institute, City of Hope | Los Angeles, California 91010 |
Veterans Affairs Outpatient Clinic - Martinez | Martinez, California 94553 |
CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
CCOP - Santa Rosa Memorial Hospital | Santa Rosa, California 95403 |
David Grant Medical Center | Travis Air Force Base, California 94535 |
CCOP - Central Illinois | Springfield, Illinois 62526 |
Veterans Affairs Medical Center - Lexington | Lexington, Kentucky 40511-1093 |
Tulane University School of Medicine | New Orleans, Louisiana 70112 |
Veterans Affairs Medical Center - Boston (Jamaica Plain) | Jamaica Plain, Massachusetts 02130 |
Veterans Affairs Medical Center - Ann Arbor | Ann Arbor, Michigan 48105 |
St. Louis University Health Sciences Center | Saint Louis, Missouri 63110-0250 |
CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
St. Francis Medical Center | Trenton, New Jersey 08629 |
CCOP - Columbus | Columbus, Ohio 43206 |
Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
CCOP - Dayton | Kettering, Ohio 45429 |
CCOP - Columbia River Program | Portland, Oregon 97213 |
CCOP - Greenville | Greenville, South Carolina 29615 |
University of Texas Medical Branch | Galveston, Texas 77555-1329 |
Veterans Affairs Medical Center - White River Junction | White River Junction, Vermont 05009 |
Swedish Cancer Institute | Seattle, Washington 98104 |
MBCCOP - University of New Mexico HSC | Albuquerque, New Mexico 87131 |
CCOP - Scott and White Hospital | Temple, Texas 76508 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
St. Barnabas Medical Center | Livingston, New Jersey 07039 |
North Shore University Hospital | Manhasset, New York 11030 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
Veterans Affairs Medical Center - Tucson | Tucson, Arizona 85723 |
University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Veterans Affairs Medical Center - Little Rock (McClellan) | Little Rock, Arkansas 72205 |
Veterans Affairs Medical Center - Denver | Denver, Colorado 80220 |
Dwight David Eisenhower Army Medical Center | Fort Gordon, Georgia 30905-5650 |
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) | Hines, Illinois 60141 |
University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Veterans Affairs Medical Center - Wichita | Wichita, Kansas 67218 |
Louisiana State University Health Sciences Center - Shreveport | Shreveport, Louisiana 71130-3932 |
Veterans Affairs Medical Center - Shreveport | Shreveport, Louisiana 71130 |
Boston Medical Center | Boston, Massachusetts 02118 |
Veterans Affairs Medical Center - Detroit | Detroit, Michigan 48201-1932 |
Providence Hospital - Southfield | Southfield, Michigan 48075-9975 |
Veterans Affairs Medical Center - Biloxi | Biloxi, Mississippi 39531-2410 |
Veterans Affairs Medical Center - Jackson | Jackson, Mississippi 39216 |
Keesler Medical Center - Keesler AFB | Keesler AFB, Mississippi 39534-2576 |
Veterans Affairs Medical Center - Kansas City | Kansas City, Missouri 64128 |
CCOP - St. Louis-Cape Girardeau | Saint Louis, Missouri 63141 |
Veterans Affairs Medical Center - Albuquerque | Albuquerque, New Mexico 87108-5138 |
Herbert Irving Comprehensive Cancer Center | New York, New York 10032 |
Veterans Affairs Medical Center - Cincinnati | Cincinnati, Ohio 45220-2288 |
Oklahoma Medical Research Foundation | Oklahoma City, Oklahoma 73104 |
Veterans Affairs Medical Center - Oklahoma City | Oklahoma City, Oklahoma 73104 |
Veterans Affairs Medical Center - Portland | Portland, Oregon 97207 |
Brooke Army Medical Center | Fort Sam Houston, Texas 78234-6200 |
Texas Tech University Health Science Center | Lubbock, Texas 79415 |
Veterans Affairs Medical Center - San Antonio (Murphy) | San Antonio, Texas 78284 |
Veterans Affairs Medical Center - Temple | Temple, Texas 76504 |
Veterans Affairs Medical Center - Salt Lake City | Salt Lake City, Utah 84148 |
CCOP - Virginia Mason Research Center | Seattle, Washington 98101 |
Veterans Affairs Medical Center - Seattle | Seattle, Washington 98108 |
CCOP - Northwest | Tacoma, Washington 98405-0986 |
Veterans Affairs Medical Center - Phoenix (Hayden) | Phoenix, Arizona 85012 |
Veterans Affairs Medical Center - New Orleans | New Orleans, Louisiana 70112 |
CCOP - Grand Rapids Clinical Oncology Program | Grand Rapids, Michigan 49503 |
Oregon Cancer Center at Oregon Health Sciences University | Portland, Oregon 97201-3098 |
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse, New York 13217 |
Veterans Affairs Medical Center - Memphis | Memphis, Tennessee 38104 |
Veterans Affairs Medical Center - Richmond | Richmond, Virginia 23249 |
University of Illinois at Chicago Health Sciences Center | Chicago, Illinois 60612 |
Veterans Affairs Medical Center - Togus | Togus, Maine 04330 |
Veterans Affairs Medical Center - Minneapolis | Minneapolis, Minnesota 55417 |
University of Missouri | Columbia, Missouri 65212 |
Veterans Affairs Medical Center - Columbia (Truman Memorial) | Columbia, Missouri 65201 |
University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
Hunterdon Regional Cancer Center | Flemington, New Jersey 08822 |
Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Riverview Medical Center | Red Bank, New Jersey 07701 |
Veterans Affairs Medical Center - Buffalo | Buffalo, New York 14215 |
Veterans Affairs Medical Center - Syracuse | Syracuse, New York 13210 |
Veterans Affairs Medical Center - Durham | Durham, North Carolina 27705 |