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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

survival

Outcome Time Frame:

At time of death

Safety Issue:

No

Principal Investigator

Timothy L. Winton, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Alberta

Authority:

United States: Federal Government

Study ID:

BR10

NCT ID:

NCT00002583

Start Date:

July 1994

Completion Date:

December 2009

Related Keywords:

  • Lung Cancer
  • stage I non-small cell lung cancer
  • stage II non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
Roswell Park Cancer InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800
Chao Family Comprehensive Cancer CenterOrange, California  92868
University of Colorado Cancer CenterDenver, Colorado  80262
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Chicago Cancer Research CenterChicago, Illinois  60637
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts  01655
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical CenterWinston-Salem, North Carolina  27157-1082
Barrett Cancer Center, The University HospitalCincinnati, Ohio  45219
Medical University of South CarolinaCharleston, South Carolina  29425-0721
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
Simmons Cancer Center - DallasDallas, Texas  75235-9154
University of Washington Medical CenterSeattle, Washington  98195-6043
University of California Davis Medical CenterSacramento, California  95817
CCOP - WichitaWichita, Kansas  67214-3882
MBCCOP - LSU Medical CenterNew Orleans, Louisiana  70112
Rhode Island HospitalProvidence, Rhode Island  02903
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - Greater PhoenixPhoenix, Arizona  85006-2726
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
University of California San Diego Cancer CenterLa Jolla, California  92093-0658
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Marlene & Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
Barnes-Jewish HospitalSaint Louis, Missouri  63110
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
CCOP - North Shore University HospitalManhasset, New York  11030
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
University of Tennessee, Memphis Cancer CenterMemphis, Tennessee  38103
MBCCOP - Massey Cancer CenterRichmond, Virginia  23298-0037
Mount Sinai Medical Center, NYNew York, New York  10029
Loyola University Medical CenterMaywood, Illinois  60153
New York Presbyterian Hospital - Cornell CampusNew York, New York  10021
Morristown Memorial HospitalMorristown, New Jersey  07962-1956
Henry Ford HospitalDetroit, Michigan  48202
Huntsman Cancer InstituteSalt Lake City, Utah  84112
Veterans Affairs Medical Center - BirminghamBirmingham, Alabama  35233
MBCCOP - University of South AlabamaMobile, Alabama  36688
Veterans Affairs Medical Center - Long BeachLong Beach, California  90822
Beckman Research Institute, City of HopeLos Angeles, California  91010
Veterans Affairs Outpatient Clinic - MartinezMartinez, California  94553
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
CCOP - Santa Rosa Memorial HospitalSanta Rosa, California  95403
David Grant Medical CenterTravis Air Force Base, California  94535
CCOP - Central IllinoisSpringfield, Illinois  62526
Veterans Affairs Medical Center - LexingtonLexington, Kentucky  40511-1093
Tulane University School of MedicineNew Orleans, Louisiana  70112
Veterans Affairs Medical Center - Boston (Jamaica Plain)Jamaica Plain, Massachusetts  02130
Veterans Affairs Medical Center - Ann ArborAnn Arbor, Michigan  48105
St. Louis University Health Sciences CenterSaint Louis, Missouri  63110-0250
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
St. Francis Medical CenterTrenton, New Jersey  08629
CCOP - ColumbusColumbus, Ohio  43206
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
CCOP - Columbia River ProgramPortland, Oregon  97213
CCOP - GreenvilleGreenville, South Carolina  29615
University of Texas Medical BranchGalveston, Texas  77555-1329
Veterans Affairs Medical Center - White River JunctionWhite River Junction, Vermont  05009
Swedish Cancer InstituteSeattle, Washington  98104
MBCCOP - University of New Mexico HSCAlbuquerque, New Mexico  87131
CCOP - Scott and White HospitalTemple, Texas  76508
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
St. Barnabas Medical CenterLivingston, New Jersey  07039
North Shore University HospitalManhasset, New York  11030
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Veterans Affairs Medical Center - TucsonTucson, Arizona  85723
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Veterans Affairs Medical Center - Little Rock (McClellan)Little Rock, Arkansas  72205
Veterans Affairs Medical Center - DenverDenver, Colorado  80220
Dwight David Eisenhower Army Medical CenterFort Gordon, Georgia  30905-5650
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)Hines, Illinois  60141
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Veterans Affairs Medical Center - WichitaWichita, Kansas  67218
Louisiana State University Health Sciences Center - ShreveportShreveport, Louisiana  71130-3932
Veterans Affairs Medical Center - ShreveportShreveport, Louisiana  71130
Boston Medical CenterBoston, Massachusetts  02118
Veterans Affairs Medical Center - DetroitDetroit, Michigan  48201-1932
Providence Hospital - SouthfieldSouthfield, Michigan  48075-9975
Veterans Affairs Medical Center - BiloxiBiloxi, Mississippi  39531-2410
Veterans Affairs Medical Center - JacksonJackson, Mississippi  39216
Keesler Medical Center - Keesler AFBKeesler AFB, Mississippi  39534-2576
Veterans Affairs Medical Center - Kansas CityKansas City, Missouri  64128
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Veterans Affairs Medical Center - AlbuquerqueAlbuquerque, New Mexico  87108-5138
Herbert Irving Comprehensive Cancer CenterNew York, New York  10032
Veterans Affairs Medical Center - CincinnatiCincinnati, Ohio  45220-2288
Oklahoma Medical Research FoundationOklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - Oklahoma CityOklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - PortlandPortland, Oregon  97207
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Texas Tech University Health Science CenterLubbock, Texas  79415
Veterans Affairs Medical Center - San Antonio (Murphy)San Antonio, Texas  78284
Veterans Affairs Medical Center - TempleTemple, Texas  76504
Veterans Affairs Medical Center - Salt Lake CitySalt Lake City, Utah  84148
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
Veterans Affairs Medical Center - SeattleSeattle, Washington  98108
CCOP - NorthwestTacoma, Washington  98405-0986
Veterans Affairs Medical Center - Phoenix (Hayden)Phoenix, Arizona  85012
Veterans Affairs Medical Center - New OrleansNew Orleans, Louisiana  70112
CCOP - Grand Rapids Clinical Oncology ProgramGrand Rapids, Michigan  49503
Oregon Cancer Center at Oregon Health Sciences UniversityPortland, Oregon  97201-3098
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
Veterans Affairs Medical Center - MemphisMemphis, Tennessee  38104
Veterans Affairs Medical Center - RichmondRichmond, Virginia  23249
University of Illinois at Chicago Health Sciences CenterChicago, Illinois  60612
Veterans Affairs Medical Center - TogusTogus, Maine  04330
Veterans Affairs Medical Center - MinneapolisMinneapolis, Minnesota  55417
University of MissouriColumbia, Missouri  65212
Veterans Affairs Medical Center - Columbia (Truman Memorial)Columbia, Missouri  65201
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Hunterdon Regional Cancer CenterFlemington, New Jersey  08822
Hackensack University Medical CenterHackensack, New Jersey  07601
Riverview Medical CenterRed Bank, New Jersey  07701
Veterans Affairs Medical Center - BuffaloBuffalo, New York  14215
Veterans Affairs Medical Center - SyracuseSyracuse, New York  13210
Veterans Affairs Medical Center - DurhamDurham, North Carolina  27705