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

NCT ID: NCT02856581

Last Updated: 2022-07-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-29

Study Completion Date

2022-04-15

Brief Summary

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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.

Detailed Description

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PRIMARY OBJECTIVES:

I. 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:

I. 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.

V. 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

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Lung Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Intervention group (varenicline and behavioral intervention)

Patients 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.

Group Type EXPERIMENTAL

Varenicline

Intervention Type DRUG

Given PO

Tobacco Cessation Counseling

Intervention Type OTHER

Complete counseling session

Control group (placebo and behavioral intervention)

Patients 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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Given PO

Tobacco Cessation Counseling

Intervention Type OTHER

Complete counseling session

Interventions

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Varenicline

Given PO

Intervention Type DRUG

Placebo

Given PO

Intervention Type DRUG

Tobacco Cessation Counseling

Complete counseling session

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ivana Croghan, PhD

Role: STUDY_CHAIR

Mayo

Locations

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Fairbanks Memorial Hospital

Fairbanks, Alaska, United States

Site Status

Kingman Regional Medical Center

Kingman, Arizona, United States

Site Status

Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

Jonesboro, Arkansas, United States

Site Status

PCR Oncology

Arroyo Grande, California, United States

Site Status

Veterans Affairs Loma Linda Healthcare System

Loma Linda, California, United States

Site Status

Eisenhower Medical Center

Rancho Mirage, California, United States

Site Status

Saint Helena Hospital

St. Helena, California, United States

Site Status

Rocky Mountain Cancer Centers-Aurora

Aurora, Colorado, United States

Site Status

The Medical Center of Aurora

Aurora, Colorado, United States

Site Status

University of Colorado Hospital

Aurora, Colorado, United States

Site Status

Boulder Community Hospital

Boulder, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, United States

Site Status

UCHealth Memorial Hospital Central

Colorado Springs, Colorado, United States

Site Status

Memorial Hospital North

Colorado Springs, Colorado, United States

Site Status

Cancer Center of Colorado at Sloan's Lake

Denver, Colorado, United States

Site Status

National Jewish Health-Main Campus

Denver, Colorado, United States

Site Status

The Women's Imaging Center

Denver, Colorado, United States

Site Status

Colorado Blood Cancer Institute

Denver, Colorado, United States

Site Status

Presbyterian - Saint Lukes Medical Center - Health One

Denver, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Midtown

Denver, Colorado, United States

Site Status

SCL Health Saint Joseph Hospital

Denver, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Rose

Denver, Colorado, United States

Site Status

Rose Medical Center

Denver, Colorado, United States

Site Status

Western Surgical Care

Denver, Colorado, United States

Site Status

Mountain Blue Cancer Care Center - Swedish

Englewood, Colorado, United States

Site Status

Swedish Medical Center

Englewood, Colorado, United States

Site Status

National Jewish Health-Western Hematology Oncology

Golden, Colorado, United States

Site Status

Saint Mary's Hospital and Regional Medical Center

Grand Junction, Colorado, United States

Site Status

North Colorado Medical Center

Greeley, Colorado, United States

Site Status

Good Samaritan Medical Center

Lafayette, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Littleton

Littleton, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Sky Ridge

Lone Tree, Colorado, United States

Site Status

Sky Ridge Medical Center

Lone Tree, Colorado, United States

Site Status

McKee Medical Center

Loveland, Colorado, United States

Site Status

National Jewish Health-Northern Hematology Oncology

Thornton, Colorado, United States

Site Status

SCL Health Lutheran Medical Center

Wheat Ridge, Colorado, United States

Site Status

Middlesex Hospital

Middletown, Connecticut, United States

Site Status

Veterans Affairs Connecticut Healthcare System-West Haven Campus

West Haven, Connecticut, United States

Site Status

Broward Health Medical Center

Fort Lauderdale, Florida, United States

Site Status

University of Florida Health Science Center - Gainesville

Gainesville, Florida, United States

Site Status

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Hollywood, Florida, United States

Site Status

Memorial Hospital West

Pembroke Pines, Florida, United States

Site Status

Indian River Medical Center

Vero Beach, Florida, United States

Site Status

Piedmont Hospital

Atlanta, Georgia, United States

Site Status

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, United States

Site Status

Summit Cancer Care-Candler

Savannah, Georgia, United States

Site Status

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, United States

Site Status

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, United States

Site Status

Kootenai Medical Center

Coeur d'Alene, Idaho, United States

Site Status

Walter Knox Memorial Hospital

Emmett, Idaho, United States

Site Status

Idaho Urologic Institute-Meridian

Meridian, Idaho, United States

Site Status

Saint Alphonsus Medical Center-Nampa

Nampa, Idaho, United States

Site Status

Kootenai Cancer Center

Post Falls, Idaho, United States

Site Status

Kootenai Cancer Clinic

Sandpoint, Idaho, United States

Site Status

Northwest Community Hospital

Arlington Heights, Illinois, United States

Site Status

Rush - Copley Medical Center

Aurora, Illinois, United States

Site Status

Illinois CancerCare-Bloomington

Bloomington, Illinois, United States

Site Status

Illinois CancerCare-Canton

Canton, Illinois, United States

Site Status

Memorial Hospital of Carbondale

Carbondale, Illinois, United States

Site Status

SIH Cancer Institute

Carterville, Illinois, United States

Site Status

Illinois CancerCare-Carthage

Carthage, Illinois, United States

Site Status

Centralia Oncology Clinic

Centralia, Illinois, United States

Site Status

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, United States

Site Status

University of Illinois

Chicago, Illinois, United States

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Carle on Vermilion

Danville, Illinois, United States

Site Status

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, United States

Site Status

Decatur Memorial Hospital

Decatur, Illinois, United States

Site Status

Illinois CancerCare-Dixon

Dixon, Illinois, United States

Site Status

Carle Physician Group-Effingham

Effingham, Illinois, United States

Site Status

Crossroads Cancer Center

Effingham, Illinois, United States

Site Status

Illinois CancerCare-Eureka

Eureka, Illinois, United States

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Illinois CancerCare-Galesburg

Galesburg, Illinois, United States

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Western Illinois Cancer Treatment Center

Galesburg, Illinois, United States

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Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, United States

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Illinois CancerCare-Macomb

Macomb, Illinois, United States

Site Status

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States

Site Status

Loyola University Medical Center

Maywood, Illinois, United States

Site Status

Marjorie Weinberg Cancer Center at Loyola-Gottlieb

Melrose Park, Illinois, United States

Site Status

Trinity Medical Center

Moline, Illinois, United States

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Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, United States

Site Status

Illinois CancerCare-Pekin

Pekin, Illinois, United States

Site Status

OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center

Pekin, Illinois, United States

Site Status

Illinois CancerCare-Peoria

Peoria, Illinois, United States

Site Status

OSF Saint Francis Radiation Oncology at Peoria Cancer Center

Peoria, Illinois, United States

Site Status

Methodist Medical Center of Illinois

Peoria, Illinois, United States

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OSF Saint Francis Medical Center

Peoria, Illinois, United States

Site Status

Illinois CancerCare-Peru

Peru, Illinois, United States

Site Status

Valley Radiation Oncology

Peru, Illinois, United States

Site Status

Illinois CancerCare-Princeton

Princeton, Illinois, United States

Site Status

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Site Status

Springfield Clinic

Springfield, Illinois, United States

Site Status

Memorial Medical Center

Springfield, Illinois, United States

Site Status

Cancer Care Specialists of Illinois-Swansea

Swansea, Illinois, United States

Site Status

Southwest Illinois Health Services LLP

Swansea, Illinois, United States

Site Status

Carle Cancer Center

Urbana, Illinois, United States

Site Status

The Carle Foundation Hospital

Urbana, Illinois, United States

Site Status

Rush-Copley Healthcare Center

Yorkville, Illinois, United States

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Deaconess Clinic Downtown

Evansville, Indiana, United States

Site Status

Parkview Hospital Randallia

Fort Wayne, Indiana, United States

Site Status

Parkview Regional Medical Center

Fort Wayne, Indiana, United States

Site Status

Franciscan Health Indianapolis

Indianapolis, Indiana, United States

Site Status

Woodland Cancer Care Center

Michigan City, Indiana, United States

Site Status

Memorial Regional Cancer Center Day Road

Mishawaka, Indiana, United States

Site Status

Franciscan Health Mooresville

Mooresville, Indiana, United States

Site Status

Chancellor Center for Oncology

Newburgh, Indiana, United States

Site Status

Reid Health

Richmond, Indiana, United States

Site Status

Memorial Hospital of South Bend

South Bend, Indiana, United States

Site Status

Baptist Health Corbin

Corbin, Kentucky, United States

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Baptist Health Lexington

Lexington, Kentucky, United States

Site Status

Baptist Health Louisville

Louisville, Kentucky, United States

Site Status

Baptist Health Madisonville/Merle Mahr Cancer Center

Madisonville, Kentucky, United States

Site Status

Baptist Health Paducah

Paducah, Kentucky, United States

Site Status

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, United States

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Medical Center of Baton Rouge

Baton Rouge, Louisiana, United States

Site Status

Ochsner High Grove

Baton Rouge, Louisiana, United States

Site Status

Ochsner Medical Center Jefferson

New Orleans, Louisiana, United States

Site Status

Eastern Maine Medical Center

Bangor, Maine, United States

Site Status

Lafayette Family Cancer Center-EMMC

Brewer, Maine, United States

Site Status

UM Upper Chesapeake Medical Center

Bel Air, Maryland, United States

Site Status

Mercy Medical Center

Springfield, Massachusetts, United States

Site Status

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, United States

Site Status

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Site Status

IHA Hematology Oncology Consultants-Brighton

Brighton, Michigan, United States

Site Status

Saint Joseph Mercy Brighton

Brighton, Michigan, United States

Site Status

IHA Hematology Oncology Consultants-Canton

Canton, Michigan, United States

Site Status

Saint Joseph Mercy Canton

Canton, Michigan, United States

Site Status

Caro Cancer Center

Caro, Michigan, United States

Site Status

IHA Hematology Oncology Consultants-Chelsea

Chelsea, Michigan, United States

Site Status

Saint Joseph Mercy Chelsea

Chelsea, Michigan, United States

Site Status

Hematology Oncology Consultants-Clarkston

Clarkston, Michigan, United States

Site Status

Newland Medical Associates-Clarkston

Clarkston, Michigan, United States

Site Status

Beaumont Hospital - Dearborn

Dearborn, Michigan, United States

Site Status

Ascension Saint John Hospital

Detroit, Michigan, United States

Site Status

Great Lakes Cancer Management Specialists-Doctors Park

East China Township, Michigan, United States

Site Status

Genesee Cancer and Blood Disease Treatment Center

Flint, Michigan, United States

Site Status

Genesee Hematology Oncology PC

Flint, Michigan, United States

Site Status

Genesys Hurley Cancer Institute

Flint, Michigan, United States

Site Status

Hurley Medical Center

Flint, Michigan, United States

Site Status

Academic Hematology Oncology Specialists

Grosse Pointe Woods, Michigan, United States

Site Status

Great Lakes Cancer Management Specialists-Van Elslander Cancer Center

Grosse Pointe Woods, Michigan, United States

Site Status

Michigan Breast Specialists-Grosse Pointe Woods

Grosse Pointe Woods, Michigan, United States

Site Status

Allegiance Health

Jackson, Michigan, United States

Site Status

Sparrow Hospital

Lansing, Michigan, United States

Site Status

Hope Cancer Clinic

Livonia, Michigan, United States

Site Status

Saint Mary Mercy Hospital

Livonia, Michigan, United States

Site Status

Great Lakes Cancer Management Specialists-Macomb Medical Campus

Macomb, Michigan, United States

Site Status

Michigan Breast Specialists-Macomb Township

Macomb, Michigan, United States

Site Status

Saint Mary's Oncology/Hematology Associates of Marlette

Marlette, Michigan, United States

Site Status

UP Health System Hematology Oncology Marquette

Marquette, Michigan, United States

Site Status

UP Health System Marquette

Marquette, Michigan, United States

Site Status

21st Century Oncology-Pontiac

Pontiac, Michigan, United States

Site Status

Hope Cancer Center

Pontiac, Michigan, United States

Site Status

Newland Medical Associates-Pontiac

Pontiac, Michigan, United States

Site Status

Saint Joseph Mercy Oakland

Pontiac, Michigan, United States

Site Status

Huron Medical Center PC

Port Huron, Michigan, United States

Site Status

Lake Huron Medical Center

Port Huron, Michigan, United States

Site Status

Great Lakes Cancer Management Specialists-Rochester Hills

Rochester Hills, Michigan, United States

Site Status

Ascension Saint Mary's Hospital

Saginaw, Michigan, United States

Site Status

Oncology Hematology Associates of Saginaw Valley PC

Saginaw, Michigan, United States

Site Status

Bhadresh Nayak MD PC-Sterling Heights

Sterling Heights, Michigan, United States

Site Status

Ascension Saint Joseph Hospital

Tawas City, Michigan, United States

Site Status

Advanced Breast Care Center PLLC

Warren, Michigan, United States

Site Status

Great Lakes Cancer Management Specialists-Macomb Professional Building

Warren, Michigan, United States

Site Status

Macomb Hematology Oncology PC

Warren, Michigan, United States

Site Status

Michigan Breast Specialists-Warren

Warren, Michigan, United States

Site Status

Saint John Macomb-Oakland Hospital

Warren, Michigan, United States

Site Status

Saint Mary's Oncology/Hematology Associates of West Branch

West Branch, Michigan, United States

Site Status

Huron Gastroenterology PC

Ypsilanti, Michigan, United States

Site Status

IHA Hematology Oncology Consultants-Ann Arbor

Ypsilanti, Michigan, United States

Site Status

Mayo Clinic Health Systems-Mankato

Mankato, Minnesota, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Coborn Cancer Center at Saint Cloud Hospital

Saint Cloud, Minnesota, United States

Site Status

Saint Cloud Hospital

Saint Cloud, Minnesota, United States

Site Status

Baptist Memorial Hospital and Cancer Center-Golden Triangle

Columbus, Mississippi, United States

Site Status

University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status

Baptist Memorial Hospital and Cancer Center-Union County

New Albany, Mississippi, United States

Site Status

Baptist Memorial Hospital and Cancer Center-Oxford

Oxford, Mississippi, United States

Site Status

Singing River Hospital

Pascagoula, Mississippi, United States

Site Status

Baptist Memorial Hospital and Cancer Center-Desoto

Southhaven, Mississippi, United States

Site Status

Parkland Health Center-Bonne Terre

Bonne Terre, Missouri, United States

Site Status

Saint Francis Medical Center

Cape Girardeau, Missouri, United States

Site Status

Southeast Cancer Center

Cape Girardeau, Missouri, United States

Site Status

Parkland Health Center - Farmington

Farmington, Missouri, United States

Site Status

Capital Region Southwest Campus

Jefferson City, Missouri, United States

Site Status

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, United States

Site Status

Missouri Baptist Medical Center

St Louis, Missouri, United States

Site Status

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, United States

Site Status

Missouri Baptist Outpatient Center-Sunset Hills

Sunset Hills, Missouri, United States

Site Status

Community Hospital of Anaconda

Anaconda, Montana, United States

Site Status

Billings Clinic Cancer Center

Billings, Montana, United States

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Saint Vincent Healthcare

Billings, Montana, United States

Site Status

Saint Vincent Frontier Cancer Center

Billings, Montana, United States

Site Status

Bozeman Deaconess Hospital

Bozeman, Montana, United States

Site Status

Saint James Community Hospital and Cancer Treatment Center

Butte, Montana, United States

Site Status

Benefis Healthcare- Sletten Cancer Institute

Great Falls, Montana, United States

Site Status

Great Falls Clinic

Great Falls, Montana, United States

Site Status

Saint Peter's Community Hospital

Helena, Montana, United States

Site Status

Kalispell Regional Medical Center

Kalispell, Montana, United States

Site Status

Community Medical Hospital

Missoula, Montana, United States

Site Status

Nebraska Methodist Hospital

Omaha, Nebraska, United States

Site Status

Carson Tahoe Regional Medical Center

Carson City, Nevada, United States

Site Status

Cancer and Blood Specialists-Henderson

Henderson, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada - Henderson

Henderson, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada-Horizon Ridge

Henderson, Nevada, United States

Site Status

Las Vegas Cancer Center-Henderson

Henderson, Nevada, United States

Site Status

OptumCare Cancer Care at Seven Hills

Henderson, Nevada, United States

Site Status

21st Century Oncology-Henderson

Henderson, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada-Southeast Henderson

Henderson, Nevada, United States

Site Status

Las Vegas Urology - Green Valley

Henderson, Nevada, United States

Site Status

Las Vegas Urology - Pebble

Henderson, Nevada, United States

Site Status

Urology Specialists of Nevada - Green Valley

Henderson, Nevada, United States

Site Status

Las Vegas Urology - Pecos

Las Vegas, Nevada, United States

Site Status

Desert West Surgery

Las Vegas, Nevada, United States

Site Status

University Medical Center of Southern Nevada

Las Vegas, Nevada, United States

Site Status

Hope Cancer Care of Nevada

Las Vegas, Nevada, United States

Site Status

Cancer and Blood Specialists-Shadow

Las Vegas, Nevada, United States

Site Status

OptumCare Cancer Care at Oakey

Las Vegas, Nevada, United States

Site Status

Radiation Oncology Centers of Nevada Central

Las Vegas, Nevada, United States

Site Status

Urology Specialists of Nevada - Central

Las Vegas, Nevada, United States

Site Status

21st Century Oncology

Las Vegas, Nevada, United States

Site Status

HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway

Las Vegas, Nevada, United States

Site Status

Sunrise Hospital and Medical Center

Las Vegas, Nevada, United States

Site Status

HealthCare Partners Medical Group Oncology/Hematology-San Martin

Las Vegas, Nevada, United States

Site Status

Las Vegas Prostate Cancer Center

Las Vegas, Nevada, United States

Site Status

Las Vegas Urology - Sunset

Las Vegas, Nevada, United States

Site Status

Radiation Oncology Centers of Nevada Southeast

Las Vegas, Nevada, United States

Site Status

Cancer Therapy and Integrative Medicine

Las Vegas, Nevada, United States

Site Status

21st Century Oncology-Vegas Tenaya

Las Vegas, Nevada, United States

Site Status

Ann M Wierman MD LTD

Las Vegas, Nevada, United States

Site Status

Cancer and Blood Specialists-Tenaya

Las Vegas, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada - Northwest

Las Vegas, Nevada, United States

Site Status

HealthCare Partners Medical Group Oncology/Hematology-Tenaya

Las Vegas, Nevada, United States

Site Status

Las Vegas Urology - Cathedral Rock

Las Vegas, Nevada, United States

Site Status

Las Vegas Urology - Smoke Ranch

Las Vegas, Nevada, United States

Site Status

OptumCare Cancer Care at MountainView

Las Vegas, Nevada, United States

Site Status

Urology Specialists of Nevada - Northwest

Las Vegas, Nevada, United States

Site Status

Alliance for Childhood Diseases/Cure 4 the Kids Foundation

Las Vegas, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada - Town Center

Las Vegas, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada-Summerlin

Las Vegas, Nevada, United States

Site Status

Summerlin Hospital Medical Center

Las Vegas, Nevada, United States

Site Status

Las Vegas Cancer Center-Medical Center

Las Vegas, Nevada, United States

Site Status

21st Century Oncology-Fort Apache

Las Vegas, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Site Status

OptumCare Cancer Care at Fort Apache

Las Vegas, Nevada, United States

Site Status

Urology Specialists of Nevada - Southwest

Las Vegas, Nevada, United States

Site Status

HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills

Las Vegas, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada - Central Valley

Las Vegas, Nevada, United States

Site Status

University Cancer Center

Las Vegas, Nevada, United States

Site Status

Hope Cancer Care of Nevada-Pahrump

Pahrump, Nevada, United States

Site Status

Renown Regional Medical Center

Reno, Nevada, United States

Site Status

Saint Mary's Regional Medical Center

Reno, Nevada, United States

Site Status

Radiation Oncology Associates

Reno, Nevada, United States

Site Status

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Ocean Medical Center

Brick, New Jersey, United States

Site Status

Hunterdon Medical Center

Flemington, New Jersey, United States

Site Status

The Cancer Institute of New Jersey Hamilton

Hamilton, New Jersey, United States

Site Status

Bayshore Community Hospital

Holmdel, New Jersey, United States

Site Status

Southern Ocean County Medical Center

Manahawkin, New Jersey, United States

Site Status

Virtua Memorial

Mount Holly, New Jersey, United States

Site Status

Jersey Shore Medical Center

Neptune City, New Jersey, United States

Site Status

Riverview Medical Center/Booker Cancer Center

Red Bank, New Jersey, United States

Site Status

Robert Wood Johnson University Hospital Somerset

Somerville, New Jersey, United States

Site Status

Virtua Voorhees

Voorhees Township, New Jersey, United States

Site Status

Glens Falls Hospital

Glens Falls, New York, United States

Site Status

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

New York, New York, United States

Site Status

Vassar Brothers Medical Center

Poughkeepsie, New York, United States

Site Status

University of Rochester

Rochester, New York, United States

Site Status

East Carolina University

Greenville, North Carolina, United States

Site Status

Alliance Cancer Center

Alliance, Ohio, United States

Site Status

Indu and Raj Soin Medical Center

Beavercreek, Ohio, United States

Site Status

Saint Elizabeth Boardman Hospital

Boardman, Ohio, United States

Site Status

Aultman Health Foundation

Canton, Ohio, United States

Site Status

Dayton Physicians LLC-Miami Valley South

Centerville, Ohio, United States

Site Status

Miami Valley Hospital South

Centerville, Ohio, United States

Site Status

Oncology Hematology Care Inc-Kenwood

Cincinnati, Ohio, United States

Site Status

Good Samaritan Hospital - Dayton

Dayton, Ohio, United States

Site Status

Miami Valley Hospital

Dayton, Ohio, United States

Site Status

Dayton Physician LLC-Miami Valley Hospital North

Dayton, Ohio, United States

Site Status

Miami Valley Hospital North

Dayton, Ohio, United States

Site Status

Armes Family Cancer Center

Findlay, Ohio, United States

Site Status

Blanchard Valley Hospital

Findlay, Ohio, United States

Site Status

Orion Cancer Care

Findlay, Ohio, United States

Site Status

Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, United States

Site Status

Dayton Physicians LLC-Atrium

Franklin, Ohio, United States

Site Status

Dayton Physicians LLC-Wayne

Greenville, Ohio, United States

Site Status

Wayne Hospital

Greenville, Ohio, United States

Site Status

Greater Dayton Cancer Center

Kettering, Ohio, United States

Site Status

First Dayton Cancer Care

Kettering, Ohio, United States

Site Status

Kettering Medical Center

Kettering, Ohio, United States

Site Status

Springfield Regional Cancer Center

Springfield, Ohio, United States

Site Status

Springfield Regional Medical Center

Springfield, Ohio, United States

Site Status

Dayton Physicians LLC-Upper Valley

Troy, Ohio, United States

Site Status

Upper Valley Medical Center

Troy, Ohio, United States

Site Status

Saint Joseph Warren Hospital

Warren, Ohio, United States

Site Status

Saint Elizabeth Youngstown Hospital

Youngstown, Ohio, United States

Site Status

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status

Oklahoma Cancer Specialists and Research Institute-Tulsa

Tulsa, Oklahoma, United States

Site Status

Saint Alphonsus Medical Center-Baker City

Baker City, Oregon, United States

Site Status

Saint Alphonsus Medical Center-Ontario

Ontario, Oregon, United States

Site Status

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, United States

Site Status

Lehigh Valley Hospital - Muhlenberg

Bethlehem, Pennsylvania, United States

Site Status

Geisinger Medical Center

Danville, Pennsylvania, United States

Site Status

Pocono Medical Center

East Stroudsburg, Pennsylvania, United States

Site Status

Geisinger Medical Center-Cancer Center Hazleton

Hazleton, Pennsylvania, United States

Site Status

Lehigh Valley Hospital-Hazleton

Hazleton, Pennsylvania, United States

Site Status

Geisinger Medical Oncology-Lewisburg

Lewisburg, Pennsylvania, United States

Site Status

Lewistown Hospital

Lewistown, Pennsylvania, United States

Site Status

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Geisinger Cancer Services-Pottsville

Pottsville, Pennsylvania, United States

Site Status

Community Medical Center

Scranton, Pennsylvania, United States

Site Status

Geisinger Medical Oncology-Selinsgrove

Selinsgrove, Pennsylvania, United States

Site Status

Geisinger Medical Group

State College, Pennsylvania, United States

Site Status

Mount Nittany Medical Center

State College, Pennsylvania, United States

Site Status

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, United States

Site Status

Ralph H Johnson VA Medical Center

Charleston, South Carolina, United States

Site Status

Prisma Health Cancer Institute - Laurens

Clinton, South Carolina, United States

Site Status

Prisma Health Cancer Institute - Easley

Easley, South Carolina, United States

Site Status

Prisma Health Cancer Institute - Butternut

Greenville, South Carolina, United States

Site Status

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, United States

Site Status

Prisma Health Greenville Memorial Hospital

Greenville, South Carolina, United States

Site Status

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, United States

Site Status

Prisma Health Cancer Institute - Greer

Greer, South Carolina, United States

Site Status

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, United States

Site Status

Prisma Health Cancer Institute - Spartanburg

Spartanburg, South Carolina, United States

Site Status

Baptist Memorial Hospital and Cancer Center-Memphis

Memphis, Tennessee, United States

Site Status

Baptist Memorial Hospital for Women

Memphis, Tennessee, United States

Site Status

Baylor University Medical Center

Dallas, Texas, United States

Site Status

University of Texas Medical Branch

Galveston, Texas, United States

Site Status

UTMB Cancer Center at Victory Lakes

League City, Texas, United States

Site Status

American Fork Hospital / Huntsman Intermountain Cancer Center

American Fork, Utah, United States

Site Status

Sandra L Maxwell Cancer Center

Cedar City, Utah, United States

Site Status

Logan Regional Hospital

Logan, Utah, United States

Site Status

Intermountain Medical Center

Murray, Utah, United States

Site Status

McKay-Dee Hospital Center

Ogden, Utah, United States

Site Status

Utah Valley Regional Medical Center

Provo, Utah, United States

Site Status

Riverton Hospital

Riverton, Utah, United States

Site Status

Utah Cancer Specialists-Salt Lake City

Salt Lake City, Utah, United States

Site Status

LDS Hospital

Salt Lake City, Utah, United States

Site Status

Dixie Medical Center Regional Cancer Center

St. George, Utah, United States

Site Status

Central Vermont Medical Center/National Life Cancer Treatment

Berlin Corners, Vermont, United States

Site Status

University of Vermont Medical Center

Burlington, Vermont, United States

Site Status

University of Vermont and State Agricultural College

Burlington, Vermont, United States

Site Status

Sentara Martha Jefferson Hospital

Charlottesville, Virginia, United States

Site Status

University of Virginia Cancer Center

Charlottesville, Virginia, United States

Site Status

Augusta Health Center for Cancer and Blood Disorders

Fishersville, Virginia, United States

Site Status

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Site Status

MultiCare Auburn Medical Center

Auburn, Washington, United States

Site Status

Virginia Mason Bainbridge Island Medical Center

Bainbridge Island, Washington, United States

Site Status

Overlake Hospital Medical Center

Bellevue, Washington, United States

Site Status

Virginia Mason Federal Way Medical Center

Federal Way, Washington, United States

Site Status

Tacoma/Valley Radiation Oncology Centers-Gig Harbor

Gig Harbor, Washington, United States

Site Status

MultiCare Gig Harbor Medical Park

Gig Harbor, Washington, United States

Site Status

Northwest Cancer Clinic

Kennewick, Washington, United States

Site Status

Virginia Mason Lynnwood Medical Center

Lynnwood, Washington, United States

Site Status

Jefferson Healthcare

Port Townsend, Washington, United States

Site Status

Peninsula Cancer Center

Poulsbo, Washington, United States

Site Status

MultiCare Good Samaritan Hospital

Puyallup, Washington, United States

Site Status

Tacoma/Valley Radiation Oncology Centers-Puyallup

Puyallup, Washington, United States

Site Status

Valley Medical Center

Renton, Washington, United States

Site Status

Virginia Mason Medical Center

Seattle, Washington, United States

Site Status

Rockwood Cancer Treatment Center-DHEC-Downtown

Spokane, Washington, United States

Site Status

Rockwood North Cancer Treatment Center

Spokane, Washington, United States

Site Status

Rockwood Clinic Cancer Treatment Center-Valley

Spokane Valley, Washington, United States

Site Status

Tacoma/Valley Radiation Oncology Centers-Jackson Hall

Tacoma, Washington, United States

Site Status

Mary Bridge Children's Hospital and Health Center

Tacoma, Washington, United States

Site Status

MultiCare Tacoma General Hospital

Tacoma, Washington, United States

Site Status

Tacoma/Valley Radiation Oncology Centers-Saint Joe's

Tacoma, Washington, United States

Site Status

North Star Lodge Cancer Center at Yakima Valley Memorial Hospital

Yakima, Washington, United States

Site Status

Mayo Clinic Health System-Franciscan Healthcare

La Crosse, Wisconsin, United States

Site Status

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, United States

Site Status

Cheyenne Regional Medical Center-West

Cheyenne, Wyoming, United States

Site Status

Billings Clinic-Cody

Cody, Wyoming, United States

Site Status

Welch Cancer Center

Sheridan, Wyoming, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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NCI-2016-00438

Identifier Type: REGISTRY

Identifier Source: secondary_id

A211401

Identifier Type: -

Identifier Source: org_study_id

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