Lung Cancer Clinical Trial
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
| Verified date | April 2020 |
| Source | Canadian Cancer Trials Group |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| 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 |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| NCIC Clinical Trials Group | Cancer and Leukemia Group B, Eastern Cooperative Oncology Group, National Cancer Institute (NCI), Southwest Oncology Group |
United States, Canada,
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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
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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
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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
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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
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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
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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
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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
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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 all — Click here to view all references
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