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.
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.
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
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There are 143 Locations for this study
Birmingham Alabama, 35233, United States
Mobile Alabama, 36688, United States
Phoenix Arizona, 85006, United States
Phoenix Arizona, 85012, United States
Tucson Arizona, 85723, United States
Tucson Arizona, 85724, United States
Little Rock Arkansas, 72205, United States
Little Rock Arkansas, 72205, United States
La Jolla California, 92093, United States
Long Beach California, 90822, United States
Los Angeles California, 90033, United States
Los Angeles California, 90095, United States
Los Angeles California, 91010, United States
Martinez California, 94553, United States
Oakland California, 94609, United States
Orange California, 92868, United States
Sacramento California, 95817, United States
San Francisco California, 94115, United States
Santa Rosa California, 95403, United States
Travis Air Force Base California, 94535, United States
Denver Colorado, 80220, United States
Denver Colorado, 80262, United States
Wilmington Delaware, 19899, United States
Washington District of Columbia, 20307, United States
Miami Beach Florida, 33140, United States
Atlanta Georgia, 30342, United States
Fort Gordon Georgia, 30905, United States
Honolulu Hawaii, 96813, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60637, United States
Decatur Illinois, 62526, United States
Hines Illinois, 60141, United States
Maywood Illinois, 60153, United States
Iowa City Iowa, 52242, United States
Kansas City Kansas, 66160, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67218, United States
Lexington Kentucky, 40511, United States
Lexington Kentucky, 40536, United States
New Orleans Louisiana, 70112, United States
New Orleans Louisiana, 70112, United States
New Orleans Louisiana, 70112, United States
Shreveport Louisiana, 71130, United States
Shreveport Louisiana, 71130, United States
Togus Maine, 04330, United States
Baltimore Maryland, 21201, United States
Boston Massachusetts, 02115, United States
Boston Massachusetts, 02118, United States
Jamaica Plain Massachusetts, 02130, United States
Worcester Massachusetts, 01655, United States
Ann Arbor Michigan, 48105, United States
Ann Arbor Michigan, 48109, United States
Detroit Michigan, 48201, United States
Detroit Michigan, 48201, United States
Detroit Michigan, 48202, United States
Grand Rapids Michigan, 49503, United States
Southfield Michigan, 48075, United States
Minneapolis Minnesota, 55417, United States
Minneapolis Minnesota, 55455, United States
Biloxi Mississippi, 39531, United States
Jackson Mississippi, 39216, United States
Jackson Mississippi, 39216, United States
Keesler Air Force Base Mississippi, 39534, United States
Columbia Missouri, 65201, United States
Columbia Missouri, 65203, United States
Columbia Missouri, 65212, United States
Kansas City Missouri, 64128, United States
Kansas City Missouri, 64131, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63141, United States
Springfield Missouri, 65807, United States
Billings Montana, 59101, United States
Omaha Nebraska, 68198, United States
Las Vegas Nevada, 89106, United States
Lebanon New Hampshire, 03756, United States
Flemington New Jersey, 08822, United States
Hackensack New Jersey, 07601, United States
Livingston New Jersey, 07039, United States
Morristown New Jersey, 07962, United States
Red Bank New Jersey, 07701, United States
Trenton New Jersey, 08629, United States
Albuquerque New Mexico, 87108, United States
Albuquerque New Mexico, 87131, United States
Buffalo New York, 14215, United States
Buffalo New York, 14263, United States
Manhasset New York, 11030, United States
Manhasset New York, 11030, United States
New York New York, 10021, United States
New York New York, 10021, United States
New York New York, 10029, United States
New York New York, 10032, United States
Syracuse New York, 13210, United States
Syracuse New York, 13210, United States
Syracuse New York, 13217, United States
Chapel Hill North Carolina, 27599, United States
Durham North Carolina, 27705, United States
Durham North Carolina, 27710, United States
Winston-Salem North Carolina, 27104, United States
Winston-Salem North Carolina, 27157, United States
Cincinnati Ohio, 45219, United States
Cincinnati Ohio, 45220, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43206, United States
Dayton Ohio, 45428, United States
Kettering Ohio, 45429, United States
Oklahoma City Oklahoma, 73104, United States
Oklahoma City Oklahoma, 73104, United States
Portland Oregon, 97201, United States
Portland Oregon, 97207, United States
Portland Oregon, 97213, United States
Providence Rhode Island, 02903, United States
Charleston South Carolina, 29425, United States
Greenville South Carolina, 29615, United States
Spartanburg South Carolina, 29303, United States
Memphis Tennessee, 38103, United States
Memphis Tennessee, 38104, United States
Dallas Texas, 75235, United States
Fort Sam Houston Texas, 78234, United States
Galveston Texas, 77555, United States
Lubbock Texas, 79423, United States
San Antonio Texas, 78284, United States
San Antonio Texas, 78284, United States
Temple Texas, 76504, United States
Temple Texas, 76508, United States
Salt Lake City Utah, 84132, United States
Salt Lake City Utah, 84148, United States
White River Junction Vermont, 05009, United States
Richmond Virginia, 23249, United States
Richmond Virginia, 23298, United States
Seattle Washington, 98101, United States
Seattle Washington, 98104, United States
Seattle Washington, 98108, United States
Seattle Washington, 98195, United States
Tacoma Washington, 98405, United States
Calgary Alberta, T2N 4, Canada
Edmonton Alberta, T6G 1, Canada
Edmonton Alberta, T6G 2, Canada
Vancouver British Columbia, V5Z 4, Canada
Vancouver British Columbia, V6Z 1, Canada
Victoria British Columbia, V8R 1, Canada
Winnipeg Manitoba, R3E 0, Canada
Moncton New Brunswick, E1C 8, Canada
Halifax Nova Scotia, B3H 1, Canada
London Ontario, N6A 4, Canada
Ottawa Ontario, K1H 1, Canada
St. Catharines Ontario, L2R 5, Canada
Sudbury Ontario, P3E 5, Canada
Thunder Bay Ontario, P7A 7, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5G 1, Canada
Toronto Ontario, M6R 1, Canada
Montreal Quebec, H2L-4, Canada
Montreal Quebec, H2W 1, Canada
Ste-Foy Quebec, G1V 4, Canada
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