Spots Global Cancer Trial Database for Vinorelbine + Cisplatin or No Further Therapy in Non-small Cell Lung Cancer That Has Been Surgically Removed
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Trial Identification
Brief Title: Vinorelbine + Cisplatin or No Further Therapy in Non-small Cell Lung Cancer That Has Been Surgically Removed
Official Title: 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
Study ID: NCT00002583
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. It is not yet known if combination chemotherapy is more effective than no further treatment for non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of vinorelbine plus cisplatin with that of no further therapy in treating patients who have stage I or stage II non-small cell lung cancer that has been completely removed during surgery.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Veterans Affairs Medical Center - Birmingham, Birmingham, Alabama, United States
MBCCOP - University of South Alabama, Mobile, Alabama, United States
CCOP - Greater Phoenix, Phoenix, Arizona, United States
Veterans Affairs Medical Center - Phoenix (Hayden), Phoenix, Arizona, United States
Veterans Affairs Medical Center - Tucson, Tucson, Arizona, United States
Arizona Cancer Center, Tucson, Arizona, United States
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
Veterans Affairs Medical Center - Little Rock (McClellan), Little Rock, Arkansas, United States
University of California San Diego Cancer Center, La Jolla, California, United States
Veterans Affairs Medical Center - Long Beach, Long Beach, California, United States
USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States
Beckman Research Institute, City of Hope, Los Angeles, California, United States
Veterans Affairs Outpatient Clinic - Martinez, Martinez, California, United States
CCOP - Bay Area Tumor Institute, Oakland, California, United States
Chao Family Comprehensive Cancer Center, Orange, California, United States
University of California Davis Medical Center, Sacramento, California, United States
UCSF Cancer Center and Cancer Research Institute, San Francisco, California, United States
CCOP - Santa Rosa Memorial Hospital, Santa Rosa, California, United States
David Grant Medical Center, Travis Air Force Base, California, United States
Veterans Affairs Medical Center - Denver, Denver, Colorado, United States
University of Colorado Cancer Center, Denver, Colorado, United States
CCOP - Christiana Care Health Services, Wilmington, Delaware, United States
Walter Reed Army Medical Center, Washington, District of Columbia, United States
CCOP - Mount Sinai Medical Center, Miami Beach, Florida, United States
CCOP - Atlanta Regional, Atlanta, Georgia, United States
Dwight David Eisenhower Army Medical Center, Fort Gordon, Georgia, United States
Cancer Research Center of Hawaii, Honolulu, Hawaii, United States
University of Illinois at Chicago Health Sciences Center, Chicago, Illinois, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
CCOP - Central Illinois, Decatur, Illinois, United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital), Hines, Illinois, United States
Loyola University Medical Center, Maywood, Illinois, United States
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
University of Kansas Medical Center, Kansas City, Kansas, United States
CCOP - Wichita, Wichita, Kansas, United States
Veterans Affairs Medical Center - Wichita, Wichita, Kansas, United States
Veterans Affairs Medical Center - Lexington, Lexington, Kentucky, United States
Albert B. Chandler Medical Center, University of Kentucky, Lexington, Kentucky, United States
MBCCOP - LSU Medical Center, New Orleans, Louisiana, United States
Tulane University School of Medicine, New Orleans, Louisiana, United States
Veterans Affairs Medical Center - New Orleans, New Orleans, Louisiana, United States
Louisiana State University Health Sciences Center - Shreveport, Shreveport, Louisiana, United States
Veterans Affairs Medical Center - Shreveport, Shreveport, Louisiana, United States
Veterans Affairs Medical Center - Togus, Togus, Maine, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, Maryland, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Boston Medical Center, Boston, Massachusetts, United States
Veterans Affairs Medical Center - Boston (Jamaica Plain), Jamaica Plain, Massachusetts, United States
University of Massachusetts Memorial Medical Center, Worcester, Massachusetts, United States
Veterans Affairs Medical Center - Ann Arbor, Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Veterans Affairs Medical Center - Detroit, Detroit, Michigan, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Henry Ford Hospital, Detroit, Michigan, United States
CCOP - Grand Rapids Clinical Oncology Program, Grand Rapids, Michigan, United States
Providence Hospital - Southfield, Southfield, Michigan, United States
Veterans Affairs Medical Center - Minneapolis, Minneapolis, Minnesota, United States
University of Minnesota Cancer Center, Minneapolis, Minnesota, United States
Veterans Affairs Medical Center - Biloxi, Biloxi, Mississippi, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Veterans Affairs Medical Center - Jackson, Jackson, Mississippi, United States
Keesler Medical Center - Keesler AFB, Keesler Air Force Base, Mississippi, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial), Columbia, Missouri, United States
Ellis Fischel Cancer Center - Columbia, Columbia, Missouri, United States
University of Missouri, Columbia, Missouri, United States
Veterans Affairs Medical Center - Kansas City, Kansas City, Missouri, United States
CCOP - Kansas City, Kansas City, Missouri, United States
St. Louis University Health Sciences Center, Saint Louis, Missouri, United States
Barnes-Jewish Hospital, Saint Louis, Missouri, United States
CCOP - St. Louis-Cape Girardeau, Saint Louis, Missouri, United States
CCOP - Cancer Research for the Ozarks, Springfield, Missouri, United States
CCOP - Montana Cancer Consortium, Billings, Montana, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, United States
Norris Cotton Cancer Center, Lebanon, New Hampshire, United States
Hunterdon Regional Cancer Center, Flemington, New Jersey, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
St. Barnabas Medical Center, Livingston, New Jersey, United States
Morristown Memorial Hospital, Morristown, New Jersey, United States
Riverview Medical Center, Red Bank, New Jersey, United States
St. Francis Medical Center, Trenton, New Jersey, United States
Veterans Affairs Medical Center - Albuquerque, Albuquerque, New Mexico, United States
MBCCOP - University of New Mexico HSC, Albuquerque, New Mexico, United States
Veterans Affairs Medical Center - Buffalo, Buffalo, New York, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
CCOP - North Shore University Hospital, Manhasset, New York, United States
North Shore University Hospital, Manhasset, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
New York Presbyterian Hospital - Cornell Campus, New York, New York, United States
Mount Sinai Medical Center, NY, New York, New York, United States
Herbert Irving Comprehensive Cancer Center, New York, New York, United States
State University of New York - Upstate Medical University, Syracuse, New York, United States
Veterans Affairs Medical Center - Syracuse, Syracuse, New York, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., Syracuse, New York, United States
Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, North Carolina, United States
Veterans Affairs Medical Center - Durham, Durham, North Carolina, United States
Duke Comprehensive Cancer Center, Durham, 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
Barrett Cancer Center, The University Hospital, Cincinnati, Ohio, United States
Veterans Affairs Medical Center - Cincinnati, Cincinnati, Ohio, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
CCOP - Columbus, Columbus, Ohio, United States
Veterans Affairs Medical Center - Dayton, Dayton, Ohio, United States
CCOP - Dayton, Kettering, Ohio, United States
Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma, United States
Veterans Affairs Medical Center - Oklahoma City, Oklahoma City, Oklahoma, United States
Oregon Cancer Center at Oregon Health Sciences University, Portland, Oregon, United States
Veterans Affairs Medical Center - Portland, Portland, Oregon, United States
CCOP - Columbia River Program, Portland, Oregon, United States
Rhode Island Hospital, Providence, Rhode Island, United States
Medical University of South Carolina, Charleston, South Carolina, United States
CCOP - Greenville, Greenville, South Carolina, United States
CCOP - Upstate Carolina, Spartanburg, South Carolina, United States
University of Tennessee, Memphis Cancer Center, Memphis, Tennessee, United States
Veterans Affairs Medical Center - Memphis, Memphis, Tennessee, United States
Simmons Cancer Center - Dallas, Dallas, Texas, United States
Brooke Army Medical Center, Fort Sam Houston, Texas, United States
University of Texas Medical Branch, Galveston, Texas, United States
Texas Tech University Health Science Center, Lubbock, Texas, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Veterans Affairs Medical Center - San Antonio (Murphy), San Antonio, Texas, United States
Veterans Affairs Medical Center - Temple, Temple, Texas, United States
CCOP - Scott and White Hospital, Temple, Texas, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Veterans Affairs Medical Center - Salt Lake City, Salt Lake City, Utah, United States
Veterans Affairs Medical Center - White River Junction, White River Junction, Vermont, United States
Veterans Affairs Medical Center - Richmond, Richmond, Virginia, United States
MBCCOP - Massey Cancer Center, Richmond, Virginia, United States
CCOP - Virginia Mason Research Center, Seattle, Washington, United States
Swedish Cancer Institute, Seattle, Washington, United States
Veterans Affairs Medical Center - Seattle, Seattle, Washington, United States
University of Washington Medical Center, Seattle, Washington, United States
CCOP - Northwest, Tacoma, Washington, United States
Tom Baker Cancer Center - Calgary, Calgary, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
University of Alberta Hospital, Edmonton, Alberta, Canada
BC Cancer Agency, Vancouver, British Columbia, Canada
St. Paul's Hospital - Vancouver, Vancouver, British Columbia, Canada
British Columbia Cancer Agency - Vancouver Island Cancer Centre, Victoria, British Columbia, Canada
CancerCare Manitoba, Winnipeg, Manitoba, Canada
Doctor Leon Richard Oncology Centre, Moncton, New Brunswick, Canada
Nova Scotia Cancer Centre, Halifax, Nova Scotia, Canada
Cancer Care Ontario-London Regional Cancer Centre, London, Ontario, Canada
Ottawa Regional Cancer Centre - General Campus, Ottawa, Ontario, Canada
Hotel Dieu Hospital - St. Catharines, St. Catharines, Ontario, Canada
Northeastern Ontario Regional Cancer Centre, Sudbury, Sudbury, Ontario, Canada
Northwestern Ontario Regional Cancer Centre, Thunder Bay, Thunder Bay, Ontario, Canada
Toronto Sunnybrook Regional Cancer Centre, Toronto, Ontario, Canada
Mount Sinai Hospital - Toronto, Toronto, Ontario, Canada
Saint Joseph's Health Centre - Toronto, Toronto, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal, Montreal, Quebec, Canada
McGill University Department of Oncology, Montreal, Quebec, Canada
L'Hopital Laval, Ste-Foy, Quebec, Canada
Contact Details
Name: Timothy L. Winton, MD
Affiliation: University of Alberta
Role: STUDY_CHAIR
Name: Eric Vallieres, MD, FRCSC
Affiliation: University of Washington
Role: STUDY_CHAIR
Name: Russell F. DeVore, MD
Affiliation: Vanderbilt-Ingram Cancer Center
Role: STUDY_CHAIR
Name: James R. Rigas, MD
Affiliation: Norris Cotton Cancer Center
Role: STUDY_CHAIR
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