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

Sponsor
NCIC Clinical Trials Group (Other)
Overall Status
Completed
CT.gov ID
NCT00002583
Collaborator
National Cancer Institute (NCI) (NIH), Southwest Oncology Group (Other), Eastern Cooperative Oncology Group (Other), Cancer and Leukemia Group B (Other)
482
155
2
185.5
3.1
0

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

Study Type:
Interventional
Actual Enrollment :
482 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jul 7, 1994
Actual Primary Completion Date :
Apr 25, 2004
Actual Study Completion Date :
Dec 21, 2009

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

  1. survival [At time of death]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 120 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Responsible Party:
NCIC Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00002583
Other Study ID Numbers:
  • BR10
  • CAN-NCIC-BR10
  • CLB-9795
  • E-JBR10
  • SWOG-JBR10
  • GW-565/040
  • NCI-V94-0492
  • CDR0000063698
First Posted:
Apr 22, 2004
Last Update Posted:
Apr 3, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by NCIC Clinical Trials Group
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 3, 2020