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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00002583
Other study ID # BR10
Secondary ID CAN-NCIC-BR10CLB
Status Completed
Phase Phase 3
First received
Last updated
Start date July 7, 1994
Est. completion date December 21, 2009

Study information

Verified date April 2020
Source Canadian Cancer Trials Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 482
Est. completion date December 21, 2009
Est. primary completion date April 25, 2004
Accepts healthy volunteers No
Gender All
Age group 18 Years to 120 Years
Eligibility 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

Study Design


Intervention

Drug:
cisplatin
50 mg/m2 IV
vinorelbine ditartrate
25 mg/m2 IV

Locations

Country Name City State
Canada Tom Baker Cancer Center - Calgary Calgary Alberta
Canada Cross Cancer Institute Edmonton Alberta
Canada University of Alberta Hospital Edmonton Alberta
Canada Nova Scotia Cancer Centre Halifax Nova Scotia
Canada Cancer Care Ontario-London Regional Cancer Centre London Ontario
Canada Doctor Leon Richard Oncology Centre Moncton New Brunswick
Canada Centre Hospitalier de l'Universite de Montreal Montreal Quebec
Canada McGill University Department of Oncology Montreal Quebec
Canada Ottawa Regional Cancer Centre - General Campus Ottawa Ontario
Canada Hotel Dieu Hospital - St. Catharines St. Catharines Ontario
Canada L'Hopital Laval Ste-Foy Quebec
Canada Northeastern Ontario Regional Cancer Centre, Sudbury Sudbury Ontario
Canada Northwestern Ontario Regional Cancer Centre, Thunder Bay Thunder Bay Ontario
Canada Mount Sinai Hospital - Toronto Toronto Ontario
Canada Saint Joseph's Health Centre - Toronto Toronto Ontario
Canada Toronto Sunnybrook Regional Cancer Centre Toronto Ontario
Canada BC Cancer Agency Vancouver British Columbia
Canada St. Paul's Hospital - Vancouver Vancouver British Columbia
Canada British Columbia Cancer Agency - Vancouver Island Cancer Centre Victoria British Columbia
Canada CancerCare Manitoba Winnipeg Manitoba
United States MBCCOP - University of New Mexico HSC Albuquerque New Mexico
United States Veterans Affairs Medical Center - Albuquerque Albuquerque New Mexico
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States Veterans Affairs Medical Center - Ann Arbor Ann Arbor Michigan
United States CCOP - Atlanta Regional Atlanta Georgia
United States Marlene & Stewart Greenebaum Cancer Center, University of Maryland Baltimore Maryland
United States CCOP - Montana Cancer Consortium Billings Montana
United States Veterans Affairs Medical Center - Biloxi Biloxi Mississippi
United States Veterans Affairs Medical Center - Birmingham Birmingham Alabama
United States Boston Medical Center Boston Massachusetts
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Roswell Park Cancer Institute Buffalo New York
United States Veterans Affairs Medical Center - Buffalo Buffalo New York
United States Lineberger Comprehensive Cancer Center, UNC Chapel Hill North Carolina
United States Medical University of South Carolina Charleston South Carolina
United States University of Chicago Cancer Research Center Chicago Illinois
United States University of Illinois at Chicago Health Sciences Center Chicago Illinois
United States Barrett Cancer Center, The University Hospital Cincinnati Ohio
United States Veterans Affairs Medical Center - Cincinnati Cincinnati Ohio
United States Cleveland Clinic Taussig Cancer Center Cleveland Ohio
United States Ellis Fischel Cancer Center - Columbia Columbia Missouri
United States University of Missouri Columbia Missouri
United States Veterans Affairs Medical Center - Columbia (Truman Memorial) Columbia Missouri
United States CCOP - Columbus Columbus Ohio
United States Simmons Cancer Center - Dallas Dallas Texas
United States Veterans Affairs Medical Center - Dayton Dayton Ohio
United States CCOP - Central Illinois Decatur Illinois
United States University of Colorado Cancer Center Denver Colorado
United States Veterans Affairs Medical Center - Denver Denver Colorado
United States Barbara Ann Karmanos Cancer Institute Detroit Michigan
United States Henry Ford Hospital Detroit Michigan
United States Veterans Affairs Medical Center - Detroit Detroit Michigan
United States Duke Comprehensive Cancer Center Durham North Carolina
United States Veterans Affairs Medical Center - Durham Durham North Carolina
United States Hunterdon Regional Cancer Center Flemington New Jersey
United States Dwight David Eisenhower Army Medical Center Fort Gordon Georgia
United States Brooke Army Medical Center Fort Sam Houston Texas
United States University of Texas Medical Branch Galveston Texas
United States CCOP - Grand Rapids Clinical Oncology Program Grand Rapids Michigan
United States CCOP - Greenville Greenville South Carolina
United States Hackensack University Medical Center Hackensack New Jersey
United States Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) Hines Illinois
United States Cancer Research Center of Hawaii Honolulu Hawaii
United States University of Iowa Hospitals and Clinics Iowa City Iowa
United States University of Mississippi Medical Center Jackson Mississippi
United States Veterans Affairs Medical Center - Jackson Jackson Mississippi
United States Veterans Affairs Medical Center - Boston (Jamaica Plain) Jamaica Plain Massachusetts
United States CCOP - Kansas City Kansas City Missouri
United States University of Kansas Medical Center Kansas City Kansas
United States Veterans Affairs Medical Center - Kansas City Kansas City Missouri
United States Keesler Medical Center - Keesler AFB Keesler Air Force Base Mississippi
United States CCOP - Dayton Kettering Ohio
United States University of California San Diego Cancer Center La Jolla California
United States CCOP - Southern Nevada Cancer Research Foundation Las Vegas Nevada
United States Norris Cotton Cancer Center Lebanon New Hampshire
United States Albert B. Chandler Medical Center, University of Kentucky Lexington Kentucky
United States Veterans Affairs Medical Center - Lexington Lexington Kentucky
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States Veterans Affairs Medical Center - Little Rock (McClellan) Little Rock Arkansas
United States St. Barnabas Medical Center Livingston New Jersey
United States Veterans Affairs Medical Center - Long Beach Long Beach California
United States Beckman Research Institute, City of Hope Los Angeles California
United States Jonsson Comprehensive Cancer Center, UCLA Los Angeles California
United States USC/Norris Comprehensive Cancer Center Los Angeles California
United States Texas Tech University Health Science Center Lubbock Texas
United States CCOP - North Shore University Hospital Manhasset New York
United States North Shore University Hospital Manhasset New York
United States Veterans Affairs Outpatient Clinic - Martinez Martinez California
United States Loyola University Medical Center Maywood Illinois
United States University of Tennessee, Memphis Cancer Center Memphis Tennessee
United States Veterans Affairs Medical Center - Memphis Memphis Tennessee
United States CCOP - Mount Sinai Medical Center Miami Beach Florida
United States University of Minnesota Cancer Center Minneapolis Minnesota
United States Veterans Affairs Medical Center - Minneapolis Minneapolis Minnesota
United States MBCCOP - University of South Alabama Mobile Alabama
United States Morristown Memorial Hospital Morristown New Jersey
United States MBCCOP - LSU Medical Center New Orleans Louisiana
United States Tulane University School of Medicine New Orleans Louisiana
United States Veterans Affairs Medical Center - New Orleans New Orleans Louisiana
United States Herbert Irving Comprehensive Cancer Center New York New York
United States Memorial Sloan-Kettering Cancer Center New York New York
United States Mount Sinai Medical Center, NY New York New York
United States New York Presbyterian Hospital - Cornell Campus New York New York
United States CCOP - Bay Area Tumor Institute Oakland California
United States Oklahoma Medical Research Foundation Oklahoma City Oklahoma
United States Veterans Affairs Medical Center - Oklahoma City Oklahoma City Oklahoma
United States University of Nebraska Medical Center Omaha Nebraska
United States Chao Family Comprehensive Cancer Center Orange California
United States CCOP - Greater Phoenix Phoenix Arizona
United States Veterans Affairs Medical Center - Phoenix (Hayden) Phoenix Arizona
United States CCOP - Columbia River Program Portland Oregon
United States Oregon Cancer Center at Oregon Health Sciences University Portland Oregon
United States Veterans Affairs Medical Center - Portland Portland Oregon
United States Rhode Island Hospital Providence Rhode Island
United States Riverview Medical Center Red Bank New Jersey
United States MBCCOP - Massey Cancer Center Richmond Virginia
United States Veterans Affairs Medical Center - Richmond Richmond Virginia
United States University of California Davis Medical Center Sacramento California
United States Barnes-Jewish Hospital Saint Louis Missouri
United States CCOP - St. Louis-Cape Girardeau Saint Louis Missouri
United States St. Louis University Health Sciences Center Saint Louis Missouri
United States Huntsman Cancer Institute Salt Lake City Utah
United States Veterans Affairs Medical Center - Salt Lake City Salt Lake City Utah
United States University of Texas Health Science Center at San Antonio San Antonio Texas
United States Veterans Affairs Medical Center - San Antonio (Murphy) San Antonio Texas
United States UCSF Cancer Center and Cancer Research Institute San Francisco California
United States CCOP - Santa Rosa Memorial Hospital Santa Rosa California
United States CCOP - Virginia Mason Research Center Seattle Washington
United States Swedish Cancer Institute Seattle Washington
United States University of Washington Medical Center Seattle Washington
United States Veterans Affairs Medical Center - Seattle Seattle Washington
United States Louisiana State University Health Sciences Center - Shreveport Shreveport Louisiana
United States Veterans Affairs Medical Center - Shreveport Shreveport Louisiana
United States Providence Hospital - Southfield Southfield Michigan
United States CCOP - Upstate Carolina Spartanburg South Carolina
United States CCOP - Cancer Research for the Ozarks Springfield Missouri
United States CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. Syracuse New York
United States State University of New York - Upstate Medical University Syracuse New York
United States Veterans Affairs Medical Center - Syracuse Syracuse New York
United States CCOP - Northwest Tacoma Washington
United States CCOP - Scott and White Hospital Temple Texas
United States Veterans Affairs Medical Center - Temple Temple Texas
United States Veterans Affairs Medical Center - Togus Togus Maine
United States David Grant Medical Center Travis Air Force Base California
United States St. Francis Medical Center Trenton New Jersey
United States Arizona Cancer Center Tucson Arizona
United States Veterans Affairs Medical Center - Tucson Tucson Arizona
United States Walter Reed Army Medical Center Washington District of Columbia
United States Veterans Affairs Medical Center - White River Junction White River Junction Vermont
United States CCOP - Wichita Wichita Kansas
United States Veterans Affairs Medical Center - Wichita Wichita Kansas
United States CCOP - Christiana Care Health Services Wilmington Delaware
United States CCOP - Southeast Cancer Control Consortium Winston-Salem North Carolina
United States Comprehensive Cancer Center of Wake Forest University Baptist Medical Center Winston-Salem North Carolina
United States University of Massachusetts Memorial Medical Center Worcester Massachusetts

Sponsors (5)

Lead Sponsor Collaborator
NCIC Clinical Trials Group Cancer and Leukemia Group B, Eastern Cooperative Oncology Group, National Cancer Institute (NCI), Southwest Oncology Group

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (26)

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.

Alam N, Shepherd FA, Winton T, Graham B, Johnson D, Livingston R, Rigas J, Whitehead M, Ding K, Seymour L. Compliance with post-operative adjuvant chemotherapy in non-small cell lung cancer. An analysis of National Cancer Institute of Canada and intergrou — View Citation

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. — View Citation

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.

Bezjak A, Lee CW, Ding K, Brundage M, Winton T, Graham B, Whitehead M, Johnson DH, Livingston RB, Seymour L, Shepherd FA. Quality-of-life outcomes for adjuvant chemotherapy in early-stage non-small-cell lung cancer: results from a randomized trial, JBR.10 — View Citation

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.

Butts CA, Ding K, Seymour L, Twumasi-Ankrah P, Graham B, Gandara D, Johnson DH, Kesler KA, Green M, Vincent M, Cormier Y, Goss G, Findlay B, Johnston M, Tsao MS, Shepherd FA. Randomized phase III trial of vinorelbine plus cisplatin compared with observati — View Citation

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 (Supp

Gauthier I, Ding K, Winton T, Shepherd FA, Livingston R, Johnson DH, Rigas JR, Whitehead M, Graham B, Seymour L. Impact of hemoglobin levels on outcomes of adjuvant chemotherapy in resected non-small cell lung cancer: the JBR.10 trial experience. Lung Can — View Citation

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.

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. — View Citation

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.

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. — View Citation

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. — View Citation

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.

Pepe C, Hasan B, Winton TL, Seymour L, Graham B, Livingston RB, Johnson DH, Rigas JR, Ding K, Shepherd FA; National Cancer Institute of Canada and Intergroup Study JBR.10. Adjuvant vinorelbine and cisplatin in elderly patients: National Cancer Institute o — View Citation

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.

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) st

Sève P, Lai R, Ding K, Winton T, Butts C, Mackey J, Dumontet C, Dabbagh L, Aviel-Ronen S, Seymour L, Whitehead M, Tsao MS, Shepherd FA, Reiman T. Class III beta-tubulin expression and benefit from adjuvant cisplatin/vinorelbine chemotherapy in operable no — View Citation

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. [A

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.

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. — View Citation

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. — View Citation

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.

Winton T, Livingston R, Johnson D, Rigas J, Johnston M, Butts C, Cormier Y, Goss G, Inculet R, Vallieres E, Fry W, Bethune D, Ayoub J, Ding K, Seymour L, Graham B, Tsao MS, Gandara D, Kesler K, Demmy T, Shepherd F; National Cancer Institute of Canada Clin — View Citation

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)

* Note: There are 26 references in allClick here to view all references

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Primary survival At time of death
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