Vinorelbine + Cisplatin or No Further Therapy in Non-small Cell Lung Cancer That Has Been Surgically Removed
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
No Intervention: Observation Observation only |
|
Active Comparator: Chemotherapy Cisplatin and Vinorelbine |
Drug: cisplatin
50 mg/m2 IV
Drug: vinorelbine ditartrate
25 mg/m2 IV
|
Outcome Measures
Primary Outcome Measures
- survival [At time of death]
Eligibility Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Veterans Affairs Medical Center - Birmingham | Birmingham | Alabama | United States | 35233 |
2 | MBCCOP - University of South Alabama | Mobile | Alabama | United States | 36688 |
3 | CCOP - Greater Phoenix | Phoenix | Arizona | United States | 85006-2726 |
4 | Veterans Affairs Medical Center - Phoenix (Hayden) | Phoenix | Arizona | United States | 85012 |
5 | Veterans Affairs Medical Center - Tucson | Tucson | Arizona | United States | 85723 |
6 | Arizona Cancer Center | Tucson | Arizona | United States | 85724 |
7 | University of Arkansas for Medical Sciences | Little Rock | Arkansas | United States | 72205 |
8 | Veterans Affairs Medical Center - Little Rock (McClellan) | Little Rock | Arkansas | United States | 72205 |
9 | University of California San Diego Cancer Center | La Jolla | California | United States | 92093-0658 |
10 | Veterans Affairs Medical Center - Long Beach | Long Beach | California | United States | 90822 |
11 | USC/Norris Comprehensive Cancer Center | Los Angeles | California | United States | 90033-0800 |
12 | Jonsson Comprehensive Cancer Center, UCLA | Los Angeles | California | United States | 90095-1781 |
13 | Beckman Research Institute, City of Hope | Los Angeles | California | United States | 91010 |
14 | Veterans Affairs Outpatient Clinic - Martinez | Martinez | California | United States | 94553 |
15 | CCOP - Bay Area Tumor Institute | Oakland | California | United States | 94609-3305 |
16 | Chao Family Comprehensive Cancer Center | Orange | California | United States | 92868 |
17 | University of California Davis Medical Center | Sacramento | California | United States | 95817 |
18 | UCSF Cancer Center and Cancer Research Institute | San Francisco | California | United States | 94115-0128 |
19 | CCOP - Santa Rosa Memorial Hospital | Santa Rosa | California | United States | 95403 |
20 | David Grant Medical Center | Travis Air Force Base | California | United States | 94535 |
21 | Veterans Affairs Medical Center - Denver | Denver | Colorado | United States | 80220 |
22 | University of Colorado Cancer Center | Denver | Colorado | United States | 80262 |
23 | CCOP - Christiana Care Health Services | Wilmington | Delaware | United States | 19899 |
24 | Walter Reed Army Medical Center | Washington | District of Columbia | United States | 20307-5000 |
25 | CCOP - Mount Sinai Medical Center | Miami Beach | Florida | United States | 33140 |
26 | CCOP - Atlanta Regional | Atlanta | Georgia | United States | 30342-1701 |
27 | Dwight David Eisenhower Army Medical Center | Fort Gordon | Georgia | United States | 30905-5650 |
28 | Cancer Research Center of Hawaii | Honolulu | Hawaii | United States | 96813 |
29 | University of Illinois at Chicago Health Sciences Center | Chicago | Illinois | United States | 60612 |
30 | University of Chicago Cancer Research Center | Chicago | Illinois | United States | 60637 |
31 | CCOP - Central Illinois | Decatur | Illinois | United States | 62526 |
32 | Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) | Hines | Illinois | United States | 60141 |
33 | Loyola University Medical Center | Maywood | Illinois | United States | 60153 |
34 | University of Iowa Hospitals and Clinics | Iowa City | Iowa | United States | 52242 |
35 | University of Kansas Medical Center | Kansas City | Kansas | United States | 66160-7357 |
36 | CCOP - Wichita | Wichita | Kansas | United States | 67214-3882 |
37 | Veterans Affairs Medical Center - Wichita | Wichita | Kansas | United States | 67218 |
38 | Veterans Affairs Medical Center - Lexington | Lexington | Kentucky | United States | 40511-1093 |
39 | Albert B. Chandler Medical Center, University of Kentucky | Lexington | Kentucky | United States | 40536-0084 |
40 | MBCCOP - LSU Medical Center | New Orleans | Louisiana | United States | 70112 |
41 | Tulane University School of Medicine | New Orleans | Louisiana | United States | 70112 |
42 | Veterans Affairs Medical Center - New Orleans | New Orleans | Louisiana | United States | 70112 |
43 | Louisiana State University Health Sciences Center - Shreveport | Shreveport | Louisiana | United States | 71130-3932 |
44 | Veterans Affairs Medical Center - Shreveport | Shreveport | Louisiana | United States | 71130 |
45 | Veterans Affairs Medical Center - Togus | Togus | Maine | United States | 04330 |
46 | Marlene & Stewart Greenebaum Cancer Center, University of Maryland | Baltimore | Maryland | United States | 21201 |
47 | Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02115 |
48 | Boston Medical Center | Boston | Massachusetts | United States | 02118 |
49 | Veterans Affairs Medical Center - Boston (Jamaica Plain) | Jamaica Plain | Massachusetts | United States | 02130 |
50 | University of Massachusetts Memorial Medical Center | Worcester | Massachusetts | United States | 01655 |
51 | Veterans Affairs Medical Center - Ann Arbor | Ann Arbor | Michigan | United States | 48105 |
52 | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | United States | 48109-0752 |
53 | Veterans Affairs Medical Center - Detroit | Detroit | Michigan | United States | 48201-1932 |
54 | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | United States | 48201 |
55 | Henry Ford Hospital | Detroit | Michigan | United States | 48202 |
56 | CCOP - Grand Rapids Clinical Oncology Program | Grand Rapids | Michigan | United States | 49503 |
57 | Providence Hospital - Southfield | Southfield | Michigan | United States | 48075-9975 |
58 | Veterans Affairs Medical Center - Minneapolis | Minneapolis | Minnesota | United States | 55417 |
59 | University of Minnesota Cancer Center | Minneapolis | Minnesota | United States | 55455 |
60 | Veterans Affairs Medical Center - Biloxi | Biloxi | Mississippi | United States | 39531-2410 |
61 | University of Mississippi Medical Center | Jackson | Mississippi | United States | 39216-4505 |
62 | Veterans Affairs Medical Center - Jackson | Jackson | Mississippi | United States | 39216 |
63 | Keesler Medical Center - Keesler AFB | Keesler Air Force Base | Mississippi | United States | 39534-2576 |
64 | Veterans Affairs Medical Center - Columbia (Truman Memorial) | Columbia | Missouri | United States | 65201 |
65 | Ellis Fischel Cancer Center - Columbia | Columbia | Missouri | United States | 65203 |
66 | University of Missouri | Columbia | Missouri | United States | 65212 |
67 | Veterans Affairs Medical Center - Kansas City | Kansas City | Missouri | United States | 64128 |
68 | CCOP - Kansas City | Kansas City | Missouri | United States | 64131 |
69 | St. Louis University Health Sciences Center | Saint Louis | Missouri | United States | 63110-0250 |
70 | Barnes-Jewish Hospital | Saint Louis | Missouri | United States | 63110 |
71 | CCOP - St. Louis-Cape Girardeau | Saint Louis | Missouri | United States | 63141 |
72 | CCOP - Cancer Research for the Ozarks | Springfield | Missouri | United States | 65807 |
73 | CCOP - Montana Cancer Consortium | Billings | Montana | United States | 59101 |
74 | University of Nebraska Medical Center | Omaha | Nebraska | United States | 68198-3330 |
75 | CCOP - Southern Nevada Cancer Research Foundation | Las Vegas | Nevada | United States | 89106 |
76 | Norris Cotton Cancer Center | Lebanon | New Hampshire | United States | 03756 |
77 | Hunterdon Regional Cancer Center | Flemington | New Jersey | United States | 08822 |
78 | Hackensack University Medical Center | Hackensack | New Jersey | United States | 07601 |
79 | St. Barnabas Medical Center | Livingston | New Jersey | United States | 07039 |
80 | Morristown Memorial Hospital | Morristown | New Jersey | United States | 07962-1956 |
81 | Riverview Medical Center | Red Bank | New Jersey | United States | 07701 |
82 | St. Francis Medical Center | Trenton | New Jersey | United States | 08629 |
83 | Veterans Affairs Medical Center - Albuquerque | Albuquerque | New Mexico | United States | 87108-5138 |
84 | MBCCOP - University of New Mexico HSC | Albuquerque | New Mexico | United States | 87131 |
85 | Veterans Affairs Medical Center - Buffalo | Buffalo | New York | United States | 14215 |
86 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263-0001 |
87 | CCOP - North Shore University Hospital | Manhasset | New York | United States | 11030 |
88 | North Shore University Hospital | Manhasset | New York | United States | 11030 |
89 | Memorial Sloan-Kettering Cancer Center | New York | New York | United States | 10021 |
90 | New York Presbyterian Hospital - Cornell Campus | New York | New York | United States | 10021 |
91 | Mount Sinai Medical Center, NY | New York | New York | United States | 10029 |
92 | Herbert Irving Comprehensive Cancer Center | New York | New York | United States | 10032 |
93 | State University of New York - Upstate Medical University | Syracuse | New York | United States | 13210 |
94 | Veterans Affairs Medical Center - Syracuse | Syracuse | New York | United States | 13210 |
95 | CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse | New York | United States | 13217 |
96 | Lineberger Comprehensive Cancer Center, UNC | Chapel Hill | North Carolina | United States | 27599-7295 |
97 | Veterans Affairs Medical Center - Durham | Durham | North Carolina | United States | 27705 |
98 | Duke Comprehensive Cancer Center | Durham | North Carolina | United States | 27710 |
99 | CCOP - Southeast Cancer Control Consortium | Winston-Salem | North Carolina | United States | 27104-4241 |
100 | Comprehensive Cancer Center of Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | United States | 27157-1082 |
101 | Barrett Cancer Center, The University Hospital | Cincinnati | Ohio | United States | 45219 |
102 | Veterans Affairs Medical Center - Cincinnati | Cincinnati | Ohio | United States | 45220-2288 |
103 | Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | United States | 44195 |
104 | CCOP - Columbus | Columbus | Ohio | United States | 43206 |
105 | Veterans Affairs Medical Center - Dayton | Dayton | Ohio | United States | 45428 |
106 | CCOP - Dayton | Kettering | Ohio | United States | 45429 |
107 | Oklahoma Medical Research Foundation | Oklahoma City | Oklahoma | United States | 73104 |
108 | Veterans Affairs Medical Center - Oklahoma City | Oklahoma City | Oklahoma | United States | 73104 |
109 | Oregon Cancer Center at Oregon Health Sciences University | Portland | Oregon | United States | 97201-3098 |
110 | Veterans Affairs Medical Center - Portland | Portland | Oregon | United States | 97207 |
111 | CCOP - Columbia River Program | Portland | Oregon | United States | 97213 |
112 | Rhode Island Hospital | Providence | Rhode Island | United States | 02903 |
113 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425-0721 |
114 | CCOP - Greenville | Greenville | South Carolina | United States | 29615 |
115 | CCOP - Upstate Carolina | Spartanburg | South Carolina | United States | 29303 |
116 | University of Tennessee, Memphis Cancer Center | Memphis | Tennessee | United States | 38103 |
117 | Veterans Affairs Medical Center - Memphis | Memphis | Tennessee | United States | 38104 |
118 | Simmons Cancer Center - Dallas | Dallas | Texas | United States | 75235-9154 |
119 | Brooke Army Medical Center | Fort Sam Houston | Texas | United States | 78234 |
120 | University of Texas Medical Branch | Galveston | Texas | United States | 77555-0209 |
121 | Texas Tech University Health Science Center | Lubbock | Texas | United States | 79423 |
122 | University of Texas Health Science Center at San Antonio | San Antonio | Texas | United States | 78284-7811 |
123 | Veterans Affairs Medical Center - San Antonio (Murphy) | San Antonio | Texas | United States | 78284 |
124 | Veterans Affairs Medical Center - Temple | Temple | Texas | United States | 76504 |
125 | CCOP - Scott and White Hospital | Temple | Texas | United States | 76508 |
126 | Huntsman Cancer Institute | Salt Lake City | Utah | United States | 84132 |
127 | Veterans Affairs Medical Center - Salt Lake City | Salt Lake City | Utah | United States | 84148 |
128 | Veterans Affairs Medical Center - White River Junction | White River Junction | Vermont | United States | 05009 |
129 | Veterans Affairs Medical Center - Richmond | Richmond | Virginia | United States | 23249 |
130 | MBCCOP - Massey Cancer Center | Richmond | Virginia | United States | 23298-0037 |
131 | CCOP - Virginia Mason Research Center | Seattle | Washington | United States | 98101 |
132 | Swedish Cancer Institute | Seattle | Washington | United States | 98104 |
133 | Veterans Affairs Medical Center - Seattle | Seattle | Washington | United States | 98108 |
134 | University of Washington Medical Center | Seattle | Washington | United States | 98195-6043 |
135 | CCOP - Northwest | Tacoma | Washington | United States | 98405-0986 |
136 | Tom Baker Cancer Center - Calgary | Calgary | Alberta | Canada | T2N 4N2 |
137 | Cross Cancer Institute | Edmonton | Alberta | Canada | T6G 1Z2 |
138 | University of Alberta Hospital | Edmonton | Alberta | Canada | T6G 2B7 |
139 | BC Cancer Agency | Vancouver | British Columbia | Canada | V5Z 4E6 |
140 | St. Paul's Hospital - Vancouver | Vancouver | British Columbia | Canada | V6Z 1Y6 |
141 | British Columbia Cancer Agency - Vancouver Island Cancer Centre | Victoria | British Columbia | Canada | V8R 1J8 |
142 | CancerCare Manitoba | Winnipeg | Manitoba | Canada | R3E 0V9 |
143 | Doctor Leon Richard Oncology Centre | Moncton | New Brunswick | Canada | E1C 8X3 |
144 | Nova Scotia Cancer Centre | Halifax | Nova Scotia | Canada | B3H 1V7 |
145 | Cancer Care Ontario-London Regional Cancer Centre | London | Ontario | Canada | N6A 4L6 |
146 | Ottawa Regional Cancer Centre - General Campus | Ottawa | Ontario | Canada | K1H 1C4 |
147 | Hotel Dieu Hospital - St. Catharines | St. Catharines | Ontario | Canada | L2R 5K3 |
148 | Northeastern Ontario Regional Cancer Centre, Sudbury | Sudbury | Ontario | Canada | P3E 5J1 |
149 | Northwestern Ontario Regional Cancer Centre, Thunder Bay | Thunder Bay | Ontario | Canada | P7A 7T1 |
150 | Toronto Sunnybrook Regional Cancer Centre | Toronto | Ontario | Canada | M4N 3M5 |
151 | Mount Sinai Hospital - Toronto | Toronto | Ontario | Canada | M5G 1X5 |
152 | Saint Joseph's Health Centre - Toronto | Toronto | Ontario | Canada | M6R 1B5 |
153 | Centre Hospitalier de l'Universite de Montreal | Montreal | Quebec | Canada | H2L-4M1 |
154 | McGill University Department of Oncology | Montreal | Quebec | Canada | H2W 1S6 |
155 | L'Hopital Laval | Ste-Foy | Quebec | Canada | G1V 4G5 |
Sponsors and Collaborators
- NCIC Clinical Trials Group
- National Cancer Institute (NCI)
- Southwest Oncology Group
- Eastern Cooperative Oncology Group
- Cancer and Leukemia Group B
Investigators
- Study Chair: Timothy L. Winton, MD, University of Alberta
- Study Chair: Eric Vallieres, MD, FRCSC, University of Washington
- Study Chair: Russell F. DeVore, MD, Vanderbilt-Ingram Cancer Center
- Study Chair: James R. Rigas, MD, Norris Cotton Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
- Asmis TR, Ding K, Seymour L, Shepherd FA, Leighl NB, Winton TL, Whitehead M, Spaans JN, Graham BC, Goss GD; National Cancer Institute of Canada Clinical Trials Group. Age and comorbidity as independent prognostic factors in the treatment of non small-cell lung cancer: a review of National Cancer Institute of Canada Clinical Trials Group trials. J Clin Oncol. 2008 Jan 1;26(1):54-9. doi: 10.1200/JCO.2007.12.8322.
- Hicks LK, Cheung MC, Ding K, Hasan B, Seymour L, Le Maître A, Leighl NB, Shepherd FA. Venous thromboembolism and nonsmall cell lung cancer: a pooled analysis of National Cancer Institute of Canada Clinical Trials Group trials. Cancer. 2009 Dec 1;115(23):5516-25. doi: 10.1002/cncr.24596.
- Hotta K, Matsuo K, Kiura K, Ueoka H, Tanimoto M. Advances in our understanding of postoperative adjuvant chemotherapy in resectable non-small-cell lung cancer. Curr Opin Oncol. 2006 Mar;18(2):144-50. Review.
- Kassam F, Shepherd FA, Johnston M, Visbal A, Feld R, Darling G, Keshavjee S, Pierre A, Waddell T, Leighl NB. Referral patterns for adjuvant chemotherapy in patients with completely resected non-small cell lung cancer. J Thorac Oncol. 2007 Jan;2(1):39-43.
- Ng R, Hasan B, Mittmann N, Florescu M, Shepherd FA, Ding K, Butts CA, Cormier Y, Darling G, Goss GD, Inculet R, Seymour L, Winton TL, Evans WK, Leighl NB; Working Group on Economic Analysis; Lung Disease Site Group; National Cancer Institute of Canada Clinical Trials Group. Economic analysis of NCIC CTG JBR.10: a randomized trial of adjuvant vinorelbine plus cisplatin compared with observation in early stage non-small-cell lung cancer--a report of the Working Group on Economic Analysis, and the Lung Disease Site Group, National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 2007 Jun 1;25(16):2256-61.
- Pignon JP, Tribodet H, Scagliotti GV, et al.: Lung Adjuvant Cisplatin Evaluation (LACE): a pooled analysis of five randomized clinical trials including 4,584 patients. [Abstract] J Clin Oncol 24 (Suppl 18): A-7008, 2006.
- Visbal AL, Leighl NB, Feld R, Shepherd FA. Adjuvant Chemotherapy for Early-Stage Non-small Cell Lung Cancer. Chest. 2005 Oct;128(4):2933-43. Review.
- Wakelee HA, Schiller JH, Gandara DR. Current status of adjuvant chemotherapy for stage IB non-small-cell lung cancer: implications for the New Intergroup Trial. Clin Lung Cancer. 2006 Jul;8(1):18-21. Review.
- Wheatley-Price P, Le Maître A, Ding K, Leighl N, Hirsh V, Seymour L, Bezjak A, Shepherd FA; NCIC Clinical Trials Group. The influence of sex on efficacy, adverse events, quality of life, and delivery of treatment in National Cancer Institute of Canada Clinical Trials Group non-small cell lung cancer chemotherapy trials. J Thorac Oncol. 2010 May;5(5):640-8. doi: 10.1097/JTO.0b013e3181d40a1b.
- BR10
- CAN-NCIC-BR10
- CLB-9795
- E-JBR10
- SWOG-JBR10
- GW-565/040
- NCI-V94-0492
- CDR0000063698