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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 Center Tucson, Arizona  85724
Roswell Park Cancer Institute Buffalo, New York  14263
Memorial Sloan-Kettering Cancer Center New York, New York  10021
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
USC/Norris Comprehensive Cancer Center Los Angeles, California  90033-0800
Chao Family Comprehensive Cancer Center Orange, California  92868
University of Colorado Cancer Center Denver, Colorado  80262
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
University of Chicago Cancer Research Center Chicago, Illinois  60637
University of Iowa Hospitals and Clinics Iowa City, Iowa  52242
Albert B. Chandler Medical Center, University of Kentucky Lexington, Kentucky  40536-0084
University of Massachusetts Memorial Medical Center Worcester, Massachusetts  01655
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center Winston-Salem, North Carolina  27157-1082
Barrett Cancer Center, The University Hospital Cincinnati, Ohio  45219
Medical University of South Carolina Charleston, South Carolina  29425-0721
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
Simmons Cancer Center - Dallas Dallas, Texas  75235-9154
University of Washington Medical Center Seattle, Washington  98195-6043
University of California Davis Medical Center Sacramento, California  95817
CCOP - Wichita Wichita, Kansas  67214-3882
MBCCOP - LSU Medical Center New Orleans, Louisiana  70112
Rhode Island Hospital Providence, Rhode Island  02903
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
CCOP - Greater Phoenix Phoenix, Arizona  85006-2726
CCOP - Atlanta Regional Atlanta, Georgia  30342-1701
CCOP - Kansas City Kansas City, Missouri  64131
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
University of California San Diego Cancer Center La Jolla, California  92093-0658
UCSF Cancer Center and Cancer Research Institute San Francisco, California  94115-0128
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Mount Sinai Medical Center Miami Beach, Florida  33140
Marlene & Stewart Greenebaum Cancer Center, University of Maryland Baltimore, Maryland  21201
Ellis Fischel Cancer Center - Columbia Columbia, Missouri  65203
Barnes-Jewish Hospital Saint Louis, Missouri  63110
Norris Cotton Cancer Center Lebanon, New Hampshire  03756
CCOP - North Shore University Hospital Manhasset, New York  11030
State University of New York - Upstate Medical University Syracuse, New York  13210
CCOP - Southeast Cancer Control Consortium Winston-Salem, North Carolina  27104-4241
University of Tennessee, Memphis Cancer Center Memphis, Tennessee  38103
MBCCOP - Massey Cancer Center Richmond, Virginia  23298-0037
Mount Sinai Medical Center, NY New York, New York  10029
Loyola University Medical Center Maywood, Illinois  60153
New York Presbyterian Hospital - Cornell Campus New York, New York  10021
Morristown Memorial Hospital Morristown, New Jersey  07962-1956
Henry Ford Hospital Detroit, Michigan  48202
Huntsman Cancer Institute Salt Lake City, Utah  84112
Veterans Affairs Medical Center - Birmingham Birmingham, Alabama  35233
MBCCOP - University of South Alabama Mobile, Alabama  36688
Veterans Affairs Medical Center - Long Beach Long Beach, California  90822
Beckman Research Institute, City of Hope Los Angeles, California  91010
Veterans Affairs Outpatient Clinic - Martinez Martinez, California  94553
CCOP - Bay Area Tumor Institute Oakland, California  94609-3305
CCOP - Santa Rosa Memorial Hospital Santa Rosa, California  95403
David Grant Medical Center Travis Air Force Base, California  94535
CCOP - Central Illinois Springfield, Illinois  62526
Veterans Affairs Medical Center - Lexington Lexington, Kentucky  40511-1093
Tulane University School of Medicine New Orleans, Louisiana  70112
Veterans Affairs Medical Center - Boston (Jamaica Plain) Jamaica Plain, Massachusetts  02130
Veterans Affairs Medical Center - Ann Arbor Ann Arbor, Michigan  48105
St. Louis University Health Sciences Center Saint Louis, Missouri  63110-0250
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
CCOP - Montana Cancer Consortium Billings, Montana  59101
St. Francis Medical Center Trenton, New Jersey  08629
CCOP - Columbus Columbus, Ohio  43206
Veterans Affairs Medical Center - Dayton Dayton, Ohio  45428
CCOP - Dayton Kettering, Ohio  45429
CCOP - Columbia River Program Portland, Oregon  97213
CCOP - Greenville Greenville, South Carolina  29615
University of Texas Medical Branch Galveston, Texas  77555-1329
Veterans Affairs Medical Center - White River Junction White River Junction, Vermont  05009
Swedish Cancer Institute Seattle, Washington  98104
MBCCOP - University of New Mexico HSC Albuquerque, New Mexico  87131
CCOP - Scott and White Hospital Temple, Texas  76508
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Cancer Research Center of Hawaii Honolulu, Hawaii  96813
St. Barnabas Medical Center Livingston, New Jersey  07039
North Shore University Hospital Manhasset, New York  11030
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Veterans Affairs Medical Center - Tucson Tucson, Arizona  85723
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Veterans Affairs Medical Center - Little Rock (McClellan) Little Rock, Arkansas  72205
Veterans Affairs Medical Center - Denver Denver, Colorado  80220
Dwight David Eisenhower Army Medical Center Fort Gordon, Georgia  30905-5650
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) Hines, Illinois  60141
University of Kansas Medical Center Kansas City, Kansas  66160-7353
Veterans Affairs Medical Center - Wichita Wichita, Kansas  67218
Louisiana State University Health Sciences Center - Shreveport Shreveport, Louisiana  71130-3932
Veterans Affairs Medical Center - Shreveport Shreveport, Louisiana  71130
Boston Medical Center Boston, Massachusetts  02118
Veterans Affairs Medical Center - Detroit Detroit, Michigan  48201-1932
Providence Hospital - Southfield Southfield, Michigan  48075-9975
Veterans Affairs Medical Center - Biloxi Biloxi, Mississippi  39531-2410
Veterans Affairs Medical Center - Jackson Jackson, Mississippi  39216
Keesler Medical Center - Keesler AFB Keesler AFB, Mississippi  39534-2576
Veterans Affairs Medical Center - Kansas City Kansas City, Missouri  64128
CCOP - St. Louis-Cape Girardeau Saint Louis, Missouri  63141
Veterans Affairs Medical Center - Albuquerque Albuquerque, New Mexico  87108-5138
Herbert Irving Comprehensive Cancer Center New York, New York  10032
Veterans Affairs Medical Center - Cincinnati Cincinnati, Ohio  45220-2288
Oklahoma Medical Research Foundation Oklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - Oklahoma City Oklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - Portland Portland, Oregon  97207
Brooke Army Medical Center Fort Sam Houston, Texas  78234-6200
Texas Tech University Health Science Center Lubbock, Texas  79415
Veterans Affairs Medical Center - San Antonio (Murphy) San Antonio, Texas  78284
Veterans Affairs Medical Center - Temple Temple, Texas  76504
Veterans Affairs Medical Center - Salt Lake City Salt Lake City, Utah  84148
CCOP - Virginia Mason Research Center Seattle, Washington  98101
Veterans Affairs Medical Center - Seattle Seattle, Washington  98108
CCOP - Northwest Tacoma, Washington  98405-0986
Veterans Affairs Medical Center - Phoenix (Hayden) Phoenix, Arizona  85012
Veterans Affairs Medical Center - New Orleans New Orleans, Louisiana  70112
CCOP - Grand Rapids Clinical Oncology Program Grand Rapids, Michigan  49503
Oregon Cancer Center at Oregon Health Sciences University Portland, Oregon  97201-3098
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. Syracuse, New York  13217
Veterans Affairs Medical Center - Memphis Memphis, Tennessee  38104
Veterans Affairs Medical Center - Richmond Richmond, Virginia  23249
University of Illinois at Chicago Health Sciences Center Chicago, Illinois  60612
Veterans Affairs Medical Center - Togus Togus, Maine  04330
Veterans Affairs Medical Center - Minneapolis Minneapolis, Minnesota  55417
University of Missouri Columbia, Missouri  65212
Veterans Affairs Medical Center - Columbia (Truman Memorial) Columbia, Missouri  65201
University of Nebraska Medical Center Omaha, Nebraska  68198-3330
Hunterdon Regional Cancer Center Flemington, New Jersey  08822
Hackensack University Medical Center Hackensack, New Jersey  07601
Riverview Medical Center Red Bank, New Jersey  07701
Veterans Affairs Medical Center - Buffalo Buffalo, New York  14215
Veterans Affairs Medical Center - Syracuse Syracuse, New York  13210
Veterans Affairs Medical Center - Durham Durham, North Carolina  27705