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AzTrials

Lung CarcinomaPhase 3NCT02856581

Management of Tobacco Treatment Intervention in Reducing Surgical Complications in Patients With Newly Diagnosed Lung Cancer Who Smoke Cigarettes

A Phase 3 study testing Varenicline and Tobacco Cessation Counseling in people with Lung Carcinoma, run by Alliance for Clinical Trials in Oncology at 374 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This randomized phase III trial studies how well management of a tobacco treatment intervention works in reducing surgical complications in patients with newly diagnosed lung cancer who smoke cigarettes. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Carcinoma
What is being tested?
Varenicline and Tobacco Cessation Counseling
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
23 participants
Where
374 sitesUnited States
Study dates
29 Sep 2017to 15 Apr 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult
  • Eligible patients will have a new diagnosis of lung cancer and have sought a surgical consult relating to this diagnosis
  • Surgery must be scheduled no sooner than 10 days after randomization and no more than twelve weeks after randomization
  • Have smoked daily or nearly every day in the previous 6 months up to the date of surgical consult AND have smoked at least one puff in the previous 7 days
  • Motivated to stop smoking, as indicated by a score of 6 or above on the Contemplation Ladder
  • Within the 30 days before registration, no use of: 1) any pharmacologic treatment for smoking cessation, including bupropion or nicotine replacement therapy; 2) any nicotine delivery system (i.e., e-cigarettes and vape products); or 3) be enrolled in any formal behavioral treatment program for tobacco dependence as determined by patient report
  • No allergies to and not currently using varenicline
  • No suicidal thoughts as indicated by a positive (1+) response to the PHQ9
  • No active untreated clinically significant psychiatric condition (psychosis, bipolar disorder, or depression)
  • Negative pregnancy test (serum or urine) done =< 7 days prior to registration, for women of childbearing potential only
  • A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
  • No unstable angina, myocardial infarction, or coronary angioplasty within the past 3 months or an untreated cardiac dysrhythmia
  • No history of seizures
  • No unstable neurologic, hepatic, renal, cardiovascular, lymphatic, or metabolic disease
  • Not currently on renal dialysis or has a history of significant renal impairment
  • No recent history (=< 90 days) of substance abuse (outside of tobacco) defined by National Institute on Alcohol Abuse and Alcoholism (NIAAA) as:
  • If male, drinking > 14 alcoholic beverages per week for past 1 month
  • If female, drinking > 7 alcoholic beverages per week for past 1 month
  • Use of cocaine, heroin, club drugs (i.e., 3,4-methylenedioxymethamphetamine (MDMA)/"ecstasy"), methamphetamine, or hallucinogens (e.g., lysergic acid diethylamide [LSD]) at any time during the past 1 month
  • Use of marijuana on a weekly basis for the past 1 month
  • Patients must be able to complete study questionnaires in English
  • No other household member or relative participating in the study
  • No known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder study adherence
  • Calculated creatinine clearance >= 30 mL/min * For females, use 85% of calculated creatinine clearance (CrCl) value

Trial locations and contacts

374 sites in 1 country.

300 sites in 1 country

United States300 sites

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

  • Alliance Cancer Center

    Alliance, Ohio, 44601

  • American Fork Hospital / Huntsman Intermountain Cancer Center

    American Fork, Utah, 84003

  • Community Hospital of Anaconda

    Anaconda, Montana, 59711

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Northwest Community Hospital

    Arlington Heights, Illinois, 60005

  • PCR Oncology

    Arroyo Grande, California, 93420

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • MultiCare Auburn Medical Center

    Auburn, Washington, 98001

  • Rocky Mountain Cancer Centers-Aurora

    Aurora, Colorado, 80012

  • The Medical Center of Aurora

    Aurora, Colorado, 80012

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • Rush - Copley Medical Center

    Aurora, Illinois, 60504

  • Virginia Mason Bainbridge Island Medical Center

    Bainbridge Island, Washington, 98110

  • Saint Alphonsus Medical Center-Baker City

    Baker City, Oregon, 97814

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • Medical Center of Baton Rouge

    Baton Rouge, Louisiana, 70816

  • Ochsner High Grove

    Baton Rouge, Louisiana, 70836

  • Indu and Raj Soin Medical Center

    Beavercreek, Ohio, 45431

  • UM Upper Chesapeake Medical Center

    Bel Air, Maryland, 21014

  • Overlake Hospital Medical Center

    Bellevue, Washington, 98004

  • Central Vermont Medical Center/National Life Cancer Treatment

    Berlin Corners, Vermont, 05602

  • Lehigh Valley Hospital - Muhlenberg

    Bethlehem, Pennsylvania, 18017

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Saint Vincent Healthcare

    Billings, Montana, 59101

  • Saint Vincent Frontier Cancer Center

    Billings, Montana, 59102

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

  • Saint Elizabeth Boardman Hospital

    Boardman, Ohio, 44512

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Parkland Health Center-Bonne Terre

    Bonne Terre, Missouri, 63628

  • Boulder Community Hospital

    Boulder, Colorado, 80301

  • Rocky Mountain Cancer Centers-Boulder

    Boulder, Colorado, 80304

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Lafayette Family Cancer Center-EMMC

    Brewer, Maine, 04412

  • Ocean Medical Center

    Brick, New Jersey, 08724

  • IHA Hematology Oncology Consultants-Brighton

    Brighton, Michigan, 48114

  • Saint Joseph Mercy Brighton

    Brighton, Michigan, 48114

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

  • University of Vermont and State Agricultural College

    Burlington, Vermont, 05405

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

  • Saint Alphonsus Cancer Care Center-Caldwell

    Caldwell, Idaho, 83605

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • IHA Hematology Oncology Consultants-Canton

    Canton, Michigan, 48188

  • Saint Joseph Mercy Canton

    Canton, Michigan, 48188

  • Aultman Health Foundation

    Canton, Ohio, 44710

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Southeast Cancer Center

    Cape Girardeau, Missouri, 63703

  • Memorial Hospital of Carbondale

    Carbondale, Illinois, 62902

  • Caro Cancer Center

    Caro, Michigan, 48723

  • Carson Tahoe Regional Medical Center

    Carson City, Nevada, 89703

  • SIH Cancer Institute

    Carterville, Illinois, 62918

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

  • Sandra L Maxwell Cancer Center

    Cedar City, Utah, 84720

  • Dayton Physicians LLC-Miami Valley South

    Centerville, Ohio, 45459

  • Miami Valley Hospital South

    Centerville, Ohio, 45459

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

  • Ralph H Johnson VA Medical Center

    Charleston, South Carolina, 29401

  • Sentara Martha Jefferson Hospital

    Charlottesville, Virginia, 22901

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

  • IHA Hematology Oncology Consultants-Chelsea

    Chelsea, Michigan, 48118

  • Saint Joseph Mercy Chelsea

    Chelsea, Michigan, 48118

  • Cheyenne Regional Medical Center-West

    Cheyenne, Wyoming, 82001

  • John H Stroger Jr Hospital of Cook County

    Chicago, Illinois, 60612

  • University of Illinois

    Chicago, Illinois, 60612

  • Oncology Hematology Care Inc-Kenwood

    Cincinnati, Ohio, 45236

  • Hematology Oncology Consultants-Clarkston

    Clarkston, Michigan, 48346

  • Newland Medical Associates-Clarkston

    Clarkston, Michigan, 48346

  • Prisma Health Cancer Institute - Laurens

    Clinton, South Carolina, 29325

  • Billings Clinic-Cody

    Cody, Wyoming, 82414

  • Kootenai Medical Center

    Coeur d'Alene, Idaho, 83814

  • UCHealth Memorial Hospital Central

    Colorado Springs, Colorado, 80909

  • Memorial Hospital North

    Colorado Springs, Colorado, 80920

  • Baptist Memorial Hospital and Cancer Center-Golden Triangle

    Columbus, Mississippi, 39705

  • Baptist Health Corbin

    Corbin, Kentucky, 40701

  • Baylor University Medical Center

    Dallas, Texas, 75246

  • Carle on Vermilion

    Danville, Illinois, 61832

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Good Samaritan Hospital - Dayton

    Dayton, Ohio, 45406

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Dayton Physician LLC-Miami Valley Hospital North

    Dayton, Ohio, 45415

  • Miami Valley Hospital North

    Dayton, Ohio, 45415

  • Beaumont Hospital - Dearborn

    Dearborn, Michigan, 48124

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Cancer Center of Colorado at Sloan's Lake

    Denver, Colorado, 80204

  • National Jewish Health-Main Campus

    Denver, Colorado, 80206

  • The Women's Imaging Center

    Denver, Colorado, 80209

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

  • Presbyterian - Saint Lukes Medical Center - Health One

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers-Midtown

    Denver, Colorado, 80218

  • SCL Health Saint Joseph Hospital

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers-Rose

    Denver, Colorado, 80220

  • Rose Medical Center

    Denver, Colorado, 80220

  • Western Surgical Care

    Denver, Colorado, 80220

  • Ascension Saint John Hospital

    Detroit, Michigan, 48236

  • Illinois CancerCare-Dixon

    Dixon, Illinois, 61021

  • Prisma Health Cancer Institute - Easley

    Easley, South Carolina, 29640

  • Great Lakes Cancer Management Specialists-Doctors Park

    East China Township, Michigan, 48054

  • Pocono Medical Center

    East Stroudsburg, Pennsylvania, 18301

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Walter Knox Memorial Hospital

    Emmett, Idaho, 83617

  • Mountain Blue Cancer Care Center - Swedish

    Englewood, Colorado, 80113

  • Swedish Medical Center

    Englewood, Colorado, 80113

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

  • Deaconess Clinic Downtown

    Evansville, Indiana, 47713

  • Fairbanks Memorial Hospital

    Fairbanks, Alaska, 99701

  • Parkland Health Center - Farmington

    Farmington, Missouri, 63640

  • Virginia Mason Federal Way Medical Center

    Federal Way, Washington, 98002

  • Armes Family Cancer Center

    Findlay, Ohio, 45840

  • Blanchard Valley Hospital

    Findlay, Ohio, 45840

  • Orion Cancer Care

    Findlay, Ohio, 45840

  • Augusta Health Center for Cancer and Blood Disorders

    Fishersville, Virginia, 22939

  • Hunterdon Medical Center

    Flemington, New Jersey, 08822

  • Genesee Cancer and Blood Disease Treatment Center

    Flint, Michigan, 48503

  • Genesee Hematology Oncology PC

    Flint, Michigan, 48503

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Broward Health Medical Center

    Fort Lauderdale, Florida, 33316

  • Parkview Hospital Randallia

    Fort Wayne, Indiana, 46805

  • Parkview Regional Medical Center

    Fort Wayne, Indiana, 46845

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Dayton Physicians LLC-Atrium

    Franklin, Ohio, 45005

  • University of Florida Health Science Center - Gainesville

    Gainesville, Florida, 32610

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

  • Western Illinois Cancer Treatment Center

    Galesburg, Illinois, 61401

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0565

  • Tacoma/Valley Radiation Oncology Centers-Gig Harbor

    Gig Harbor, Washington, 98332

  • MultiCare Gig Harbor Medical Park

    Gig Harbor, Washington, 98335

  • Glens Falls Hospital

    Glens Falls, New York, 12801

  • National Jewish Health-Western Hematology Oncology

    Golden, Colorado, 80401

  • Saint Mary's Hospital and Regional Medical Center

    Grand Junction, Colorado, 81501

  • Benefis Healthcare- Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • North Colorado Medical Center

    Greeley, Colorado, 80631

  • East Carolina University

    Greenville, North Carolina, 27834

  • Dayton Physicians LLC-Wayne

    Greenville, Ohio, 45331

  • Wayne Hospital

    Greenville, Ohio, 45331

  • Prisma Health Cancer Institute - Butternut

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina, 29605

  • Prisma Health Greenville Memorial Hospital

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina, 29615

  • Prisma Health Cancer Institute - Greer

    Greer, South Carolina, 29650

  • Academic Hematology Oncology Specialists

    Grosse Pointe Woods, Michigan, 48236

  • Great Lakes Cancer Management Specialists-Van Elslander Cancer Center

    Grosse Pointe Woods, Michigan, 48236

  • Michigan Breast Specialists-Grosse Pointe Woods

    Grosse Pointe Woods, Michigan, 48236

  • The Cancer Institute of New Jersey Hamilton

    Hamilton, New Jersey, 08690

  • Geisinger Medical Center-Cancer Center Hazleton

    Hazleton, Pennsylvania, 18201

  • Lehigh Valley Hospital-Hazleton

    Hazleton, Pennsylvania, 18201

  • Saint Peter's Community Hospital

    Helena, Montana, 59601

  • Cancer and Blood Specialists-Henderson

    Henderson, Nevada, 89052

  • Comprehensive Cancer Centers of Nevada - Henderson

    Henderson, Nevada, 89052

  • Comprehensive Cancer Centers of Nevada-Horizon Ridge

    Henderson, Nevada, 89052

  • Las Vegas Cancer Center-Henderson

    Henderson, Nevada, 89052

  • OptumCare Cancer Care at Seven Hills

    Henderson, Nevada, 89052

  • 21st Century Oncology-Henderson

    Henderson, Nevada, 89074

  • Comprehensive Cancer Centers of Nevada-Southeast Henderson

    Henderson, Nevada, 89074

  • Las Vegas Urology - Green Valley

    Henderson, Nevada, 89074

  • Las Vegas Urology - Pebble

    Henderson, Nevada, 89074

  • Urology Specialists of Nevada - Green Valley

    Henderson, Nevada, 89074

  • Memorial Regional Hospital/Joe DiMaggio Children's Hospital

    Hollywood, Florida, 33021

  • Bayshore Community Hospital

    Holmdel, New Jersey, 07733

  • Franciscan Health Indianapolis

    Indianapolis, Indiana, 46237

  • Allegiance Health

    Jackson, Michigan, 49201

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Capital Region Southwest Campus

    Jefferson City, Missouri, 65109

  • Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

    Jonesboro, Arkansas, 72401

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Northwest Cancer Clinic

    Kennewick, Washington, 99336

  • Greater Dayton Cancer Center

    Kettering, Ohio, 45409

  • First Dayton Cancer Care

    Kettering, Ohio, 45420

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

  • Kingman Regional Medical Center

    Kingman, Arizona, 86401

  • Mayo Clinic Health System-Franciscan Healthcare

    La Crosse, Wisconsin, 54601

  • Good Samaritan Medical Center

    Lafayette, Colorado, 80026

  • Sparrow Hospital

    Lansing, Michigan, 48912

  • Las Vegas Urology - Pecos

    Las Vegas, Nevada, 89074

  • Desert West Surgery

    Las Vegas, Nevada, 89102

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • Hope Cancer Care of Nevada

    Las Vegas, Nevada, 89103

  • Cancer and Blood Specialists-Shadow

    Las Vegas, Nevada, 89106

  • OptumCare Cancer Care at Oakey

    Las Vegas, Nevada, 89106

  • Radiation Oncology Centers of Nevada Central

    Las Vegas, Nevada, 89106

  • Urology Specialists of Nevada - Central

    Las Vegas, Nevada, 89106

  • 21st Century Oncology

    Las Vegas, Nevada, 89109

  • HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway

    Las Vegas, Nevada, 89109

  • Sunrise Hospital and Medical Center

    Las Vegas, Nevada, 89109

  • HealthCare Partners Medical Group Oncology/Hematology-San Martin

    Las Vegas, Nevada, 89113

  • Las Vegas Prostate Cancer Center

    Las Vegas, Nevada, 89113

  • Las Vegas Urology - Sunset

    Las Vegas, Nevada, 89113

  • Radiation Oncology Centers of Nevada Southeast

    Las Vegas, Nevada, 89119

  • Cancer Therapy and Integrative Medicine

    Las Vegas, Nevada, 89121

  • 21st Century Oncology-Vegas Tenaya

    Las Vegas, Nevada, 89128

  • Ann M Wierman MD LTD

    Las Vegas, Nevada, 89128

  • Cancer and Blood Specialists-Tenaya

    Las Vegas, Nevada, 89128

  • Comprehensive Cancer Centers of Nevada - Northwest

    Las Vegas, Nevada, 89128

  • HealthCare Partners Medical Group Oncology/Hematology-Tenaya

    Las Vegas, Nevada, 89128

  • Las Vegas Urology - Cathedral Rock

    Las Vegas, Nevada, 89128

  • Las Vegas Urology - Smoke Ranch

    Las Vegas, Nevada, 89128

  • OptumCare Cancer Care at MountainView

    Las Vegas, Nevada, 89128

  • Urology Specialists of Nevada - Northwest

    Las Vegas, Nevada, 89128

  • Alliance for Childhood Diseases/Cure 4 the Kids Foundation

    Las Vegas, Nevada, 89135

  • Comprehensive Cancer Centers of Nevada - Town Center

    Las Vegas, Nevada, 89144

  • Comprehensive Cancer Centers of Nevada-Summerlin

    Las Vegas, Nevada, 89144

  • Summerlin Hospital Medical Center

    Las Vegas, Nevada, 89144

  • Las Vegas Cancer Center-Medical Center

    Las Vegas, Nevada, 89148-2405

  • 21st Century Oncology-Fort Apache

    Las Vegas, Nevada, 89148

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89148

  • OptumCare Cancer Care at Fort Apache

    Las Vegas, Nevada, 89148

  • Urology Specialists of Nevada - Southwest

    Las Vegas, Nevada, 89148

  • HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills

    Las Vegas, Nevada, 89149

  • Comprehensive Cancer Centers of Nevada - Central Valley

    Las Vegas, Nevada, 89169

  • University Cancer Center

    Las Vegas, Nevada, 89169

  • UTMB Cancer Center at Victory Lakes

    League City, Texas, 77573

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Geisinger Medical Oncology-Lewisburg

    Lewisburg, Pennsylvania, 17837

  • Lewistown Hospital

    Lewistown, Pennsylvania, 17044

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • Rocky Mountain Cancer Centers-Littleton

    Littleton, Colorado, 80120

  • Hope Cancer Clinic

    Livonia, Michigan, 48154

  • Saint Mary Mercy Hospital

    Livonia, Michigan, 48154

  • Logan Regional Hospital

    Logan, Utah, 84321

  • Veterans Affairs Loma Linda Healthcare System

    Loma Linda, California, 92357

  • Rocky Mountain Cancer Centers-Sky Ridge

    Lone Tree, Colorado, 80124

  • Sky Ridge Medical Center

    Lone Tree, Colorado, 80124

  • Baptist Health Louisville

    Louisville, Kentucky, 40207

  • McKee Medical Center

    Loveland, Colorado, 80539

  • Virginia Mason Lynnwood Medical Center

    Lynnwood, Washington, 98036

  • Illinois CancerCare-Macomb

    Macomb, Illinois, 61455

  • Great Lakes Cancer Management Specialists-Macomb Medical Campus

    Macomb, Michigan, 48044

  • Michigan Breast Specialists-Macomb Township

    Macomb, Michigan, 48044

  • Baptist Health Madisonville/Merle Mahr Cancer Center

    Madisonville, Kentucky, 42431

  • Southern Ocean County Medical Center

    Manahawkin, New Jersey, 08050

  • Mayo Clinic Health Systems-Mankato

    Mankato, Minnesota, 56001

  • Saint Mary's Oncology/Hematology Associates of Marlette

    Marlette, Michigan, 48453

  • UP Health System Hematology Oncology Marquette

    Marquette, Michigan, 49855

  • UP Health System Marquette

    Marquette, Michigan, 49855

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Marjorie Weinberg Cancer Center at Loyola-Gottlieb

    Melrose Park, Illinois, 60160

  • Baptist Memorial Hospital and Cancer Center-Memphis

    Memphis, Tennessee, 38120

  • Baptist Memorial Hospital for Women

    Memphis, Tennessee, 38120

  • Idaho Urologic Institute-Meridian

    Meridian, Idaho, 83642

  • Woodland Cancer Care Center

    Michigan City, Indiana, 46360

  • Middlesex Hospital

    Middletown, Connecticut, 06457

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Memorial Regional Cancer Center Day Road

    Mishawaka, Indiana, 46545

  • Community Medical Hospital

    Missoula, Montana, 59804

  • Trinity Medical Center

    Moline, Illinois, 61265

  • Franciscan Health Mooresville

    Mooresville, Indiana, 46158

  • Virtua Memorial

    Mount Holly, New Jersey, 08060

  • Intermountain Medical Center

    Murray, Utah, 84107

  • Saint Alphonsus Medical Center-Nampa

    Nampa, Idaho, 83686

  • Jersey Shore Medical Center

    Neptune City, New Jersey, 07753

  • Baptist Memorial Hospital and Cancer Center-Union County

    New Albany, Mississippi, 38652

  • Ochsner Medical Center Jefferson

    New Orleans, Louisiana, 70121

  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

    New York, New York, 10032

  • Chancellor Center for Oncology

    Newburgh, Indiana, 47630

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • McKay-Dee Hospital Center

    Ogden, Utah, 84403

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • Saint Alphonsus Medical Center-Ontario

    Ontario, Oregon, 97914

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois, 61350

  • Baptist Memorial Hospital and Cancer Center-Oxford

    Oxford, Mississippi, 38655

  • Baptist Health Paducah

    Paducah, Kentucky, 42003

  • Hope Cancer Care of Nevada-Pahrump

    Pahrump, Nevada, 89048

  • Singing River Hospital

    Pascagoula, Mississippi, 39581

  • Illinois CancerCare-Pekin

    Pekin, Illinois, 61554

  • OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center

    Pekin, Illinois, 61554

  • Memorial Hospital West

    Pembroke Pines, Florida, 33028

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

  • OSF Saint Francis Radiation Oncology at Peoria Cancer Center

    Peoria, Illinois, 61615

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

  • Illinois CancerCare-Peru

    Peru, Illinois, 61354

  • Valley Radiation Oncology

    Peru, Illinois, 61354

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • 21st Century Oncology-Pontiac

    Pontiac, Michigan, 48341

  • Hope Cancer Center

    Pontiac, Michigan, 48341

  • Newland Medical Associates-Pontiac

    Pontiac, Michigan, 48341

  • Saint Joseph Mercy Oakland

    Pontiac, Michigan, 48341

  • Huron Medical Center PC

    Port Huron, Michigan, 48060

  • Lake Huron Medical Center

    Port Huron, Michigan, 48060

  • Jefferson Healthcare

    Port Townsend, Washington, 98368

  • Kootenai Cancer Center

    Post Falls, Idaho, 83854

  • Geisinger Cancer Services-Pottsville

    Pottsville, Pennsylvania, 17901

  • Vassar Brothers Medical Center

    Poughkeepsie, New York, 12601

  • Peninsula Cancer Center

    Poulsbo, Washington, 98370

  • Illinois CancerCare-Princeton

    Princeton, Illinois, 61356

  • Utah Valley Regional Medical Center

    Provo, Utah, 84604

  • MultiCare Good Samaritan Hospital

    Puyallup, Washington, 98372

  • Tacoma/Valley Radiation Oncology Centers-Puyallup

    Puyallup, Washington, 98372

  • Eisenhower Medical Center

    Rancho Mirage, California, 92270

  • Riverview Medical Center/Booker Cancer Center

    Red Bank, New Jersey, 07701

  • Renown Regional Medical Center

    Reno, Nevada, 89502

Other trials in United States

About this study

Official title: Reducing Surgical Complications in Newly Diagnosed Lung Cancer Patients Who Smoke Cigarettes

This randomized phase III trial studies how well management of a tobacco treatment intervention works in reducing surgical complications in patients with newly diagnosed lung cancer who smoke cigarettes. Management of a tobacco treatment intervention compares varenicline (a drug that reduces the craving and withdrawal symptoms that occur with abstinence from nicotine) and behavioral interventions (consisting of a brief clinician-delivered intervention and tobacco quitline [tobacco cessation service available through a toll-free telephone number] follow-up) with placebo (a pill with no active medication) along with similar behavioral interventions. It is not yet known whether management of a tobacco treatment intervention is more effective in reducing surgical complications than placebo.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine if varenicline plus a behavioral intervention consisting of a brief clinician-delivered intervention and tobacco quitline follow-up, decreases postsurgical complications through 24 weeks after surgery when compared to placebo plus the behavioral intervention in lung cancer patients who undergo surgery and are motivated to stop smoking.

SECONDARY OBJECTIVES:

  1. To compare changes from baseline to 12 and 24 weeks after surgery in the patient quality of life (Linear Analogue Self-Assessment [LASA]-12) domains between the intervention (varenicline) and control group (placebo).

II. To compare changes from baseline to 6, 12 and 24 weeks after surgery in the patient quality of life related domains (LASA) for the Patient Health Questionnaire (PHQ)-9 and Smoking Self Efficacy Questionnaire (SEQ)12 between the intervention and control groups.

III. To compare the proportion of patients 12 weeks and 24 weeks after surgery who endorse ("Was It Worth It") each treatment (intervention versus [vs] control groups).

IV. To compare post-operative care (as measured by length of hospital and high dependency unit stay) between the intervention and control groups.

  1. To compare treatment adherence between the intervention and control groups. VI. To compare rates of smoking abstinence between the intervention and control groups as a covariate of the primary outcome only.
Conditions
Lung Carcinoma
Being tested
Varenicline, Placebo, Tobacco Cessation Counseling
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VareniclineDrug

    Given PO

  • PlaceboDrug

    Given PO

  • Tobacco Cessation CounselingOther

    Complete counseling session

Study groups in NCT02856581
Study groupRoleWhat they receive
Intervention group (varenicline and behavioral intervention)ExperimentalPatients receive varenicline PO QD on days 1-3 and BID on days 4-84 for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete behavioral intervention consisting of no smoking message from surgical team member and how to use NCI quitline at surgical consult.
Receives: Drug: Varenicline; Other: Tobacco Cessation Counseling
Control group (placebo and behavioral intervention)Placebo comparatorPatients receive placebo PO QD on days 1-3 and BID on days 4-84 for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete behavioral intervention consisting of no smoking message from surgical team member and how to use NCI quitline at surgical consult.
Receives: Drug: Placebo; Other: Tobacco Cessation Counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality

    Number of patients that died within 30 days of surgery

    Measured: Up to 30 days post-surgery

  2. Re-hospitalization

    Number of patients re-hospitalized within 30 days of surgery

    Measured: Up to 30 days post-surgery

  3. Number of Paticipants With Incidence of Pulmonary Complications

    Surgical complication incidence rates at 24 weeks after surgery will be compared between the intervention vs. control groups using a Fisher's exact test. Logistic regression models will supplement the univariate analysis, using complication incidence as the dependent variable and will include smoking status at the time of surgery as an independent variable and also adjust for age, gender, Fagerström Test for Nicotine Dependence (FTND), time between randomization and surgery, and presence of adjuvant chemotherapy and/or radiation therapy. We will also explore the collinear relationship between arm and smoking status to see whether they can be included together in the logistic models.

    Measured: Up to 24 weeks post-surgery

  4. Number of Participants With Incidence of Intensive Care Unit Readmission

    Surgical complication incidence rates at 24 weeks after surgery will be compared between the intervention vs. control groups using a Fisher's exact test. Logistic regression models will supplement the univariate analysis, using complication incidence as the dependent variable and will include smoking status at the time of surgery as an independent variable and also adjust for age, gender, FTND, time between randomization and surgery, and presence of adjuvant chemotherapy and/or radiation therapy. A separate logistic model will be created including treatment arm instead of smoking status. We will also explore the collinear relationship between arm and smoking status to see whether they can be included together in the logistic models.

    Measured: Up to 24 weeks post-surgery

  5. Number of Participants With Incidence of Unspecified Wound Infection

    Surgical complication incidence rates at 24 weeks after surgery will be compared between the intervention vs. control groups using a Fisher's exact test. Logistic regression models will supplement the univariate analysis, using complication incidence as the dependent variable and will include smoking status at the time of surgery as an independent variable and also adjust for age, gender, FTND, time between randomization and surgery, and presence of adjuvant chemotherapy and/or radiation therapy. A separate logistic model will be created including treatment arm instead of smoking status. We will also explore the collinear relationship between arm and smoking status to see whether they can be included together in the logistic models.

    Measured: Up to 24 weeks post-surgery

  6. Number of Participants With Incidence of Anastomotic Failure

    Surgical complication incidence rates at 24 weeks after surgery will be compared between the intervention vs. control groups using a Fisher's exact test. Logistic regression models will supplement the univariate analysis, using complication incidence as the dependent variable and will include smoking status at the time of surgery as an independent variable and also adjust for age, gender, FTND, time between randomization and surgery, and presence of adjuvant chemotherapy and/or radiation therapy. A separate logistic model will be created including treatment arm instead of smoking status. We will also explore the collinear relationship between arm and smoking status to see whether they can be included together in the logistic models.

    Measured: Up to 24 weeks post-surgery

Secondary outcomes (9)

  1. Change in QOL as Measured by the LASA-12, PHQ-9, SEQ-12

    Analysis of covariance and linear mixed model repeated measures analysis will be used for each assessment domain (LASA-12, PHQ-9, SEQ12).

    Measured: Baseline up to 24 weeks after surgery

  2. Change in QOL as Measured by Was It Worth It Assessments

    Measured: At 12 weeks after surgery

  3. Change in QOL as Measured by Was It Worth It Assessments

    Measured: At 24 weeks after surgery

  4. Length of Hospital Stay

    Logrank testing of Kaplan-Meier estimates will be used for length of hospital stay and supplemented by Cox models to control for concomitant covariates.

    Measured: The time from surgery until the patient is released from the hospital

  5. Length of High Dependency Unit Stay

    Logrank testing of Kaplan-Meier estimates will be used for length of high dependency unit stay and supplemented by Cox models to control for concomitant covariates.

    Measured: The time from surgery until the patient is released from the hospital

  6. Expanded Complication Rate

    Measured: Up to 1 year

  7. Treatment Adherence Rates Related to Visits, Medication Compliance, Quitline Usage, and Surgeon Teachable Moment Delivery

    Measured: Up to 12 weeks

  8. Smoking Abstinence Rates as Measured by Self-report

    Measured: Up to 12 weeks

  9. Smoking Abstinence Rates as Measured by Salivary Cotinine Testing

    Measured: Up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2016 (estimated)
  2. Study start29 Sep 2017
  3. Primary completion28 May 2021
  4. Study completion15 Apr 2022

Why it stopped: Slow accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02856581
Sponsor's protocol ID
A211401
Other IDs
NCI-2016-00438
Status last verified
Jun 2022
First submitted
1 Aug 2016
Last updated
27 Jul 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Varenicline and Tobacco Cessation Counseling in people with Lung Carcinoma, run by Alliance for Clinical Trials in Oncology at 374 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 374 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality (time frame: Up to 30 days post-surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02856581.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022; AzTrials last refreshed its copy on 8 Nov 2026.

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