Lung Cancer Clinical Trial

Vinorelbine + Cisplatin or No Further Therapy in Non-small Cell Lung Cancer That Has Been Surgically Removed

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically confirmed primary non-small cell lung cancer that is completely resected No mixed small and non-small cell histologies Pathologic T2 N0 or T1-2 N1 T1 N1 and T2 N1 only for CALGB institutions Removal of all gross disease with negative resection margins by lobectomy, sleeve resection, bilobectomy, or pneumonectomy (based on intraoperative findings) No segmentectomy or wedge resection Complete mediastinal lymph node resection or sampling required at primary tumor resection, with minimum levels of nodal sampling as follows: Primary in right upper lobe - levels 4, 7, 10 Primary in right middle lobe - levels 4, 7, 10 Primary in right lower lobe - levels 4, 7, 9, 10 Primary in left upper lobe - levels 5, 6, 7, 10 Primary in left lower lobe - levels 7, 9, 10 If complete mediastinal lymph node resection has not been undertaken, any mediastinal lymph node which measured 1.5 cm or more on presurgical CT scan must have been biopsied and found to be free of metastatic involvement Disease at nodal station 10 (tracheobronchial angle) is considered N2 disease for this trial and is not eligible No more than one discrete primary tumor No bronchoalveolar carcinoma with lobar or multilobar involvement Discrete solitary radiological mass or nodule eligible Snap frozen fresh primary tumor tissue must be submitted to Lung Cancer Tumor Bank within 14 days after surgery by selected Canadian centers Others to submit representative paraffin block within 2 months of surgery

PATIENT CHARACTERISTICS: Age: 18 and over (lower age limit determined by individual center) Performance status: ECOG 0 or 1 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count greater than 2,000/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 10.0 g/dL Hepatic: Bilirubin no greater than 1.25 times normal AST/ALT no greater than 1.25 times normal Alkaline phosphatase no greater than 1.25 times normal Renal: Creatinine no greater than 1.7 mg/dL Cardiovascular: No history of congestive heart failure or other cardiac abnormality that may preclude hydration necessary for cisplatin administration Other: No active pathologic condition that would preclude study No active uncontrolled infection No history of psychiatric or neurologic disorder that would preclude study No prior breast cancer, melanoma, or hypernephroma No other malignancy within the past 5 years except adequately treated nonmelanomatous skin cancer or carcinoma in situ of the cervix Not pregnant or nursing Fertile patients must use effective contraception Ability to tolerate treatment (based on consultation between the thoracic surgeon and a medical oncologist or hematologist) and available for follow-up

PRIOR CONCURRENT THERAPY: Complete resection required Randomization between 28 and 40 days after surgery required

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

482

Study ID:

NCT00002583

Recruitment Status:

Completed

Sponsor:

NCIC Clinical Trials Group

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There are 143 Locations for this study

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Veterans Affairs Medical Center - Birmingham
Birmingham Alabama, 35233, United States
MBCCOP - University of South Alabama
Mobile Alabama, 36688, United States
CCOP - Greater Phoenix
Phoenix Arizona, 85006, United States
Veterans Affairs Medical Center - Phoenix (Hayden)
Phoenix Arizona, 85012, United States
Veterans Affairs Medical Center - Tucson
Tucson Arizona, 85723, United States
Arizona Cancer Center
Tucson Arizona, 85724, United States
University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock Arkansas, 72205, United States
University of California San Diego Cancer Center
La Jolla California, 92093, United States
Veterans Affairs Medical Center - Long Beach
Long Beach California, 90822, United States
USC/Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles California, 90095, United States
Beckman Research Institute, City of Hope
Los Angeles California, 91010, United States
Veterans Affairs Outpatient Clinic - Martinez
Martinez California, 94553, United States
CCOP - Bay Area Tumor Institute
Oakland California, 94609, United States
Chao Family Comprehensive Cancer Center
Orange California, 92868, United States
University of California Davis Medical Center
Sacramento California, 95817, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco California, 94115, United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa California, 95403, United States
David Grant Medical Center
Travis Air Force Base California, 94535, United States
Veterans Affairs Medical Center - Denver
Denver Colorado, 80220, United States
University of Colorado Cancer Center
Denver Colorado, 80262, United States
CCOP - Christiana Care Health Services
Wilmington Delaware, 19899, United States
Walter Reed Army Medical Center
Washington District of Columbia, 20307, United States
CCOP - Mount Sinai Medical Center
Miami Beach Florida, 33140, United States
CCOP - Atlanta Regional
Atlanta Georgia, 30342, United States
Dwight David Eisenhower Army Medical Center
Fort Gordon Georgia, 30905, United States
Cancer Research Center of Hawaii
Honolulu Hawaii, 96813, United States
University of Illinois at Chicago Health Sciences Center
Chicago Illinois, 60612, United States
University of Chicago Cancer Research Center
Chicago Illinois, 60637, United States
CCOP - Central Illinois
Decatur Illinois, 62526, United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines Illinois, 60141, United States
Loyola University Medical Center
Maywood Illinois, 60153, United States
University of Iowa Hospitals and Clinics
Iowa City Iowa, 52242, United States
University of Kansas Medical Center
Kansas City Kansas, 66160, United States
CCOP - Wichita
Wichita Kansas, 67214, United States
Veterans Affairs Medical Center - Wichita
Wichita Kansas, 67218, United States
Veterans Affairs Medical Center - Lexington
Lexington Kentucky, 40511, United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington Kentucky, 40536, United States
MBCCOP - LSU Medical Center
New Orleans Louisiana, 70112, United States
Tulane University School of Medicine
New Orleans Louisiana, 70112, United States
Veterans Affairs Medical Center - New Orleans
New Orleans Louisiana, 70112, United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport Louisiana, 71130, United States
Veterans Affairs Medical Center - Shreveport
Shreveport Louisiana, 71130, United States
Veterans Affairs Medical Center - Togus
Togus Maine, 04330, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore Maryland, 21201, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02115, United States
Boston Medical Center
Boston Massachusetts, 02118, United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain Massachusetts, 02130, United States
University of Massachusetts Memorial Medical Center
Worcester Massachusetts, 01655, United States
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor Michigan, 48105, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States
Veterans Affairs Medical Center - Detroit
Detroit Michigan, 48201, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
CCOP - Grand Rapids Clinical Oncology Program
Grand Rapids Michigan, 49503, United States
Providence Hospital - Southfield
Southfield Michigan, 48075, United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis Minnesota, 55417, United States
University of Minnesota Cancer Center
Minneapolis Minnesota, 55455, United States
Veterans Affairs Medical Center - Biloxi
Biloxi Mississippi, 39531, United States
University of Mississippi Medical Center
Jackson Mississippi, 39216, United States
Veterans Affairs Medical Center - Jackson
Jackson Mississippi, 39216, United States
Keesler Medical Center - Keesler AFB
Keesler Air Force Base Mississippi, 39534, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia Missouri, 65201, United States
Ellis Fischel Cancer Center - Columbia
Columbia Missouri, 65203, United States
University of Missouri
Columbia Missouri, 65212, United States
Veterans Affairs Medical Center - Kansas City
Kansas City Missouri, 64128, United States
CCOP - Kansas City
Kansas City Missouri, 64131, United States
St. Louis University Health Sciences Center
Saint Louis Missouri, 63110, United States
Barnes-Jewish Hospital
Saint Louis Missouri, 63110, United States
CCOP - St. Louis-Cape Girardeau
Saint Louis Missouri, 63141, United States
CCOP - Cancer Research for the Ozarks
Springfield Missouri, 65807, United States
CCOP - Montana Cancer Consortium
Billings Montana, 59101, United States
University of Nebraska Medical Center
Omaha Nebraska, 68198, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas Nevada, 89106, United States
Norris Cotton Cancer Center
Lebanon New Hampshire, 03756, United States
Hunterdon Regional Cancer Center
Flemington New Jersey, 08822, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
St. Barnabas Medical Center
Livingston New Jersey, 07039, United States
Morristown Memorial Hospital
Morristown New Jersey, 07962, United States
Riverview Medical Center
Red Bank New Jersey, 07701, United States
St. Francis Medical Center
Trenton New Jersey, 08629, United States
Veterans Affairs Medical Center - Albuquerque
Albuquerque New Mexico, 87108, United States
MBCCOP - University of New Mexico HSC
Albuquerque New Mexico, 87131, United States
Veterans Affairs Medical Center - Buffalo
Buffalo New York, 14215, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
CCOP - North Shore University Hospital
Manhasset New York, 11030, United States
North Shore University Hospital
Manhasset New York, 11030, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10021, United States
New York Presbyterian Hospital - Cornell Campus
New York New York, 10021, United States
Mount Sinai Medical Center, NY
New York New York, 10029, United States
Herbert Irving Comprehensive Cancer Center
New York New York, 10032, United States
State University of New York - Upstate Medical University
Syracuse New York, 13210, United States
Veterans Affairs Medical Center - Syracuse
Syracuse New York, 13210, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse New York, 13217, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill North Carolina, 27599, United States
Veterans Affairs Medical Center - Durham
Durham North Carolina, 27705, United States
Duke Comprehensive Cancer Center
Durham North Carolina, 27710, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem North Carolina, 27104, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem North Carolina, 27157, United States
Barrett Cancer Center, The University Hospital
Cincinnati Ohio, 45219, United States
Veterans Affairs Medical Center - Cincinnati
Cincinnati Ohio, 45220, United States
Cleveland Clinic Taussig Cancer Center
Cleveland Ohio, 44195, United States
CCOP - Columbus
Columbus Ohio, 43206, United States
Veterans Affairs Medical Center - Dayton
Dayton Ohio, 45428, United States
CCOP - Dayton
Kettering Ohio, 45429, United States
Oklahoma Medical Research Foundation
Oklahoma City Oklahoma, 73104, United States
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City Oklahoma, 73104, United States
Oregon Cancer Center at Oregon Health Sciences University
Portland Oregon, 97201, United States
Veterans Affairs Medical Center - Portland
Portland Oregon, 97207, United States
CCOP - Columbia River Program
Portland Oregon, 97213, United States
Rhode Island Hospital
Providence Rhode Island, 02903, United States
Medical University of South Carolina
Charleston South Carolina, 29425, United States
CCOP - Greenville
Greenville South Carolina, 29615, United States
CCOP - Upstate Carolina
Spartanburg South Carolina, 29303, United States
University of Tennessee, Memphis Cancer Center
Memphis Tennessee, 38103, United States
Veterans Affairs Medical Center - Memphis
Memphis Tennessee, 38104, United States
Simmons Cancer Center - Dallas
Dallas Texas, 75235, United States
Brooke Army Medical Center
Fort Sam Houston Texas, 78234, United States
University of Texas Medical Branch
Galveston Texas, 77555, United States
Texas Tech University Health Science Center
Lubbock Texas, 79423, United States
University of Texas Health Science Center at San Antonio
San Antonio Texas, 78284, United States
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio Texas, 78284, United States
Veterans Affairs Medical Center - Temple
Temple Texas, 76504, United States
CCOP - Scott and White Hospital
Temple Texas, 76508, United States
Huntsman Cancer Institute
Salt Lake City Utah, 84132, United States
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City Utah, 84148, United States
Veterans Affairs Medical Center - White River Junction
White River Junction Vermont, 05009, United States
Veterans Affairs Medical Center - Richmond
Richmond Virginia, 23249, United States
MBCCOP - Massey Cancer Center
Richmond Virginia, 23298, United States
CCOP - Virginia Mason Research Center
Seattle Washington, 98101, United States
Swedish Cancer Institute
Seattle Washington, 98104, United States
Veterans Affairs Medical Center - Seattle
Seattle Washington, 98108, United States
University of Washington Medical Center
Seattle Washington, 98195, United States
CCOP - Northwest
Tacoma Washington, 98405, United States
Tom Baker Cancer Center - Calgary
Calgary Alberta, T2N 4, Canada
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
University of Alberta Hospital
Edmonton Alberta, T6G 2, Canada
BC Cancer Agency
Vancouver British Columbia, V5Z 4, Canada
St. Paul's Hospital - Vancouver
Vancouver British Columbia, V6Z 1, Canada
British Columbia Cancer Agency - Vancouver Island Cancer Centre
Victoria British Columbia, V8R 1, Canada
CancerCare Manitoba
Winnipeg Manitoba, R3E 0, Canada
Doctor Leon Richard Oncology Centre
Moncton New Brunswick, E1C 8, Canada
Nova Scotia Cancer Centre
Halifax Nova Scotia, B3H 1, Canada
Cancer Care Ontario-London Regional Cancer Centre
London Ontario, N6A 4, Canada
Ottawa Regional Cancer Centre - General Campus
Ottawa Ontario, K1H 1, Canada
Hotel Dieu Hospital - St. Catharines
St. Catharines Ontario, L2R 5, Canada
Northeastern Ontario Regional Cancer Centre, Sudbury
Sudbury Ontario, P3E 5, Canada
Northwestern Ontario Regional Cancer Centre, Thunder Bay
Thunder Bay Ontario, P7A 7, Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto Ontario, M4N 3, Canada
Mount Sinai Hospital - Toronto
Toronto Ontario, M5G 1, Canada
Saint Joseph's Health Centre - Toronto
Toronto Ontario, M6R 1, Canada
Centre Hospitalier de l'Universite de Montreal
Montreal Quebec, H2L-4, Canada
McGill University Department of Oncology
Montreal Quebec, H2W 1, Canada
L'Hopital Laval
Ste-Foy Quebec, G1V 4, Canada

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

482

Study ID:

NCT00002583

Recruitment Status:

Completed

Sponsor:


NCIC Clinical Trials Group

How clear is this clinincal trial information?

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