Vinorelbine Plus Cisplatin or No Further Therapy in Treating Patients With Non-small Cell Lung Cancer That Has Been Surgically Removed

This study has been completed.
Sponsor:
Collaborators:
Southwest Oncology Group
Eastern Cooperative Oncology Group
Cancer and Leukemia Group B
Information provided by (Responsible Party):
NCIC Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00002583
First received: November 1, 1999
Last updated: September 20, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Lung Cancer
Drug: cisplatin
Drug: vinorelbine ditartrate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by NCIC Clinical Trials Group:

Primary Outcome Measures:
  • survival [ Time Frame: At time of death ] [ Designated as safety issue: No ]

Enrollment: 482
Study Start Date: July 1994
Study Completion Date: December 2009
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Observation
Observation only
Active Comparator: Chemotherapy
Cisplatin and Vinorelbine
Drug: cisplatin
50 mg/m2 IV
Drug: vinorelbine ditartrate
25 mg/m2 IV

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002583

  Hide Study Locations
Locations
United States, Alabama
Veterans Affairs Medical Center - Birmingham
Birmingham, Alabama, United States, 35233
MBCCOP - University of South Alabama
Mobile, Alabama, United States, 36688
United States, Arizona
CCOP - Greater Phoenix
Phoenix, Arizona, United States, 85006-2726
Veterans Affairs Medical Center - Phoenix (Hayden)
Phoenix, Arizona, United States, 85012
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, United States, 85723
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock, Arkansas, United States, 72205
United States, California
University of California San Diego Cancer Center
La Jolla, California, United States, 92093-0658
Veterans Affairs Medical Center - Long Beach
Long Beach, California, United States, 90822
Beckman Research Institute, City of Hope
Los Angeles, California, United States, 91010
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033-0800
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, United States, 94553
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609-3305
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
University of California Davis Medical Center
Sacramento, California, United States, 95817
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States, 94115-0128
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, United States, 95403
David Grant Medical Center
Travis Air Force Base, California, United States, 94535
United States, Colorado
University of Colorado Cancer Center
Denver, Colorado, United States, 80262
Veterans Affairs Medical Center - Denver
Denver, Colorado, United States, 80220
United States, Delaware
CCOP - Christiana Care Health Services
Wilmington, Delaware, United States, 19899
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5000
United States, Florida
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
United States, Georgia
CCOP - Atlanta Regional
Atlanta, Georgia, United States, 30342-1701
Dwight David Eisenhower Army Medical Center
Fort Gordon, Georgia, United States, 30905-5650
United States, Hawaii
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
University of Illinois at Chicago Health Sciences Center
Chicago, Illinois, United States, 60612
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, United States, 60141
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7357
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, United States, 67218
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
United States, Kentucky
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States, 40536-0084
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, United States, 40511-1093
United States, Louisiana
MBCCOP - LSU Medical Center
New Orleans, Louisiana, United States, 70112
Tulane University School of Medicine
New Orleans, Louisiana, United States, 70112
Veterans Affairs Medical Center - New Orleans
New Orleans, Louisiana, United States, 70112
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, United States, 71130-3932
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, United States, 71130
United States, Maine
Veterans Affairs Medical Center - Togus
Togus, Maine, United States, 04330
United States, Maryland
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, United States, 02130
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01655
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0752
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, United States, 48105
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, United States, 48201-1932
CCOP - Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States, 49503
Providence Hospital - Southfield
Southfield, Michigan, United States, 48075-9975
United States, Minnesota
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55417
United States, Mississippi
Veterans Affairs Medical Center - Biloxi
Biloxi, Mississippi, United States, 39531-2410
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216-4505
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, United States, 39216
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, United States, 39534-2576
United States, Missouri
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States, 65203
University of Missouri
Columbia, Missouri, United States, 65212
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, United States, 65201
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, United States, 64128
CCOP - St. Louis-Cape Girardeau
Saint Louis, Missouri, United States, 63141
St. Louis University Health Sciences Center
Saint Louis, Missouri, United States, 63110-0250
Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65807
United States, Montana
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-3330
United States, Nevada
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
United States, New Hampshire
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Hunterdon Regional Cancer Center
Flemington, New Jersey, United States, 08822
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
St. Barnabas Medical Center
Livingston, New Jersey, United States, 07039
Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962-1956
Riverview Medical Center
Red Bank, New Jersey, United States, 07701
St. Francis Medical Center
Trenton, New Jersey, United States, 08629
United States, New Mexico
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, United States, 87131
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, United States, 87108-5138
United States, New York
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, United States, 14215
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
North Shore University Hospital
Manhasset, New York, United States, 11030
CCOP - North Shore University Hospital
Manhasset, New York, United States, 11030
Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
New York Presbyterian Hospital - Cornell Campus
New York, New York, United States, 10021
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Mount Sinai Medical Center, NY
New York, New York, United States, 10029
State University of New York - Upstate Medical University
Syracuse, New York, United States, 13210
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, United States, 13217
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, United States, 13210
United States, North Carolina
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States, 27599-7295
Veterans Affairs Medical Center - Durham
Durham, North Carolina, United States, 27705
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States, 27104-4241
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157-1082
United States, Ohio
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, United States, 45219
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, United States, 45220-2288
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
CCOP - Columbus
Columbus, Ohio, United States, 43206
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States, 45428
CCOP - Dayton
Kettering, Ohio, United States, 45429
United States, Oklahoma
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States, 73104
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
CCOP - Columbia River Program
Portland, Oregon, United States, 97213
Oregon Cancer Center at Oregon Health Sciences University
Portland, Oregon, United States, 97201-3098
Veterans Affairs Medical Center - Portland
Portland, Oregon, United States, 97207
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425-0721
CCOP - Greenville
Greenville, South Carolina, United States, 29615
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, United States, 38103
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, United States, 38104
United States, Texas
Simmons Cancer Center - Dallas
Dallas, Texas, United States, 75235-9154
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0209
Texas Tech University Health Science Center
Lubbock, Texas, United States, 79423
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78284-7811
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, United States, 78284
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
Veterans Affairs Medical Center - Temple
Temple, Texas, United States, 76504
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84132
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City, Utah, United States, 84148
United States, Vermont
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, United States, 05009
United States, Virginia
MBCCOP - Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, United States, 23249
United States, Washington
CCOP - Virginia Mason Research Center
Seattle, Washington, United States, 98101
Veterans Affairs Medical Center - Seattle
Seattle, Washington, United States, 98108
Swedish Cancer Institute
Seattle, Washington, United States, 98104
University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
CCOP - Northwest
Tacoma, Washington, United States, 98405-0986
Canada, Alberta
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
BC Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
St. Paul's Hospital - Vancouver
Vancouver, British Columbia, Canada, V6Z 1Y6
British Columbia Cancer Agency - Vancouver Island Cancer Centre
Victoria, British Columbia, Canada, V8R 1J8
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, New Brunswick
Doctor Leon Richard Oncology Centre
Moncton, New Brunswick, Canada, E1C 8X3
Canada, Nova Scotia
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Ottawa Regional Cancer Centre - General Campus
Ottawa, Ontario, Canada, K1H 1C4
Hotel Dieu Hospital - St. Catharines
St. Catharines, Ontario, Canada, L2R 5K3
Northeastern Ontario Regional Cancer Centre, Sudbury
Sudbury, Ontario, Canada, P3E 5J1
Northwestern Ontario Regional Cancer Centre, Thunder Bay
Thunder Bay, Ontario, Canada, P7A 7T1
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Saint Joseph's Health Centre - Toronto
Toronto, Ontario, Canada, M6R 1B5
Mount Sinai Hospital - Toronto
Toronto, Ontario, Canada, M5G 1X5
Canada, Quebec
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, H2L-4M1
McGill University Department of Oncology
Montreal, Quebec, Canada, H2W 1S6
L'Hopital Laval
Ste-Foy, Quebec, Canada, G1V 4G5
Sponsors and Collaborators
NCIC Clinical Trials Group
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
  More Information

Additional Information:
Publications:
Vincent MD, Butts C, Seymour L, et al.: Updated survival analysis of JBR.10: A randomized phase III trial of vinorelbine/cisplatin versus observation in completely resected stage IB and II non-small cell lung cancer (NSCLC). [Abstract] J Clin Oncol 27 (Suppl 15): A-7501, 2009.
Jang RW, Le Maître A, Ding K, et al.: A Q-TWiST analysis of adjuvant chemotherapy in non-small cell lung cancer (NSCLC) in the NCIC CTG JBR.10 trial. [Abstract] J Clin Oncol 26 (Suppl 15): A-6535, 2008.
Tsao MS, Zhu C, Ding K, et al.: A 15-gene expression signature prognostic for survival and predictive for adjuvant chemotherapy benefit in JBR.10 patients. [Abstract] J Clin Oncol 26 (Suppl 15): A-7510, 2008.
Bezjak A, Lee CW, Ding K, et al.: Quality of life (QOL) impact of adjuvant chemotherapy for early stage non-small cell lung cancer (NSCLC): final analysis of JBR.10 randomized trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-7585, 405s, 2007.
Tsao MS, Aviel-Ronen S, Ding K, et al.: P53 protein over-expression but not p53 gene mutation is a poor prognostic marker and a predictive marker for survival benefit from adjuvant chemotherapy in non-small cell lung cancer (NSCLC) in the JBR.10 trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-7577, 403s, 2007.
Pepe C, Hasan B, Winton T, et al.: Adjuvant chemotherapy in elderly patients: an analysis of National Cancer Institute of Canada Clinical Trials Group and Intergroup BR.10. [Abstract] J Clin Oncol 24 (Suppl 18): A-7009, 2006.
Reiman T, Lai R, Ding K, et al.: Class III beta tubulin expression and benefit from adjuvant cisplatin/vinorelbine chemotherapy in operable non-small cell lung cancer: analysis of the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) study JBR.10. [Abstract] J Clin Oncol 24 (Suppl 18): A-7051, 376s, 2006.
Gauthier I, Ding K, Winton T, et al.: Impact of hemoglobin (Hb) on outcomes of adjuvant chemotherapy (ACT) with cisplatin/vinorelbine in patients (pts) with completely resected non small cell lung cancer (NSCLC) in JBR.10. [Abstract] J Clin Oncol 23 (Suppl 16): A-7200, 670s, 2005.
Winton TL, Livingston R, Johnson D, et al.: A prospective randomised trial of adjuvant vinorelbine (VIN) and cisplatin (CIS) in completely resected stage 1B and II non small cell lung cancer (NSCLC) Intergroup JBR.10. [Abstract] J Clin Oncol 22 (Suppl 14): A-7018, 621s, 2004.
Alam N, Shepherd F, Winton T, et al.: Compliance with adjuvant chemotherapy (ACT) in non-small lung cancer (NSCLC): NCIC-CTG BR.10/JBR.10. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-2547, 633, 2003.
Beziak A, Winton T, Ding K, et al.: Quality of life in a trial of adjuvant chemotherapy for early stage completely resected non-small cell lung cancer (NCIC CTG BR.10). [Abstract] Lung Cancer 41 (Suppl 2): S20, 2003.
Wheatley-Price P, Le Maître A, Ding K, et al.: The influence of sex on efficacy, toxicity and delivery of treatment in National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) non-small cell lung cancer (NSCLC) chemotherapy trials. [Abstract] J Clin Oncol 26 (Suppl 15): A-8054, 2008.
Hicks L, Cheung M, Hasan B, et al.: Venous thromboembolism and non-small cell lung cancer: a pooled analysis of National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) trials. [Abstract] Blood 110 (11): A-3995, 2007.
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.

Responsible Party: NCIC Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00002583     History of Changes
Other Study ID Numbers: BR10, CAN-NCIC-BR10, CLB-9795, E-JBR10, SWOG-JBR10, GW-565/040, NCI-V94-0492, CDR0000063698
Study First Received: November 1, 1999
Last Updated: September 20, 2012
Health Authority: United States: Federal Government

Keywords provided by NCIC Clinical Trials Group:
stage I non-small cell lung cancer
stage II non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Vinorelbine
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on September 18, 2014