Clinical trial NCT04214262: Testing the Addition of the Drug Atezolizumab to the Usual Radiation Treatment for Patients With Early Non-small Cell Lung Cancer
Official title: A Randomized Phase III Trial of Induction/Consolidation Atezolizumab (NSC #783608) + SBRT Versus SBRT Alone in High Risk, Early Stage NSCLC
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Lung Non-Small Cell Carcinoma
Stage I Lung Cancer AJCC v8
Stage II Lung Cancer AJCC v8
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2020-01-02
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This phase III trial studies how well atezolizumab added to the usual radiation therapy works in treating patients with stage I-IIA non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy, such as stereotactic body radiation therapy, uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving atezolizumab and radiation therapy may work better than radiation therapy alone in treating patients with early non-small cell lung cancer.

Detailed description: PRIMARY OBJECTIVE:

I. To compare overall survival (OS) in patients with inoperable, early stage non-small cell lung cancer (NSCLC) randomized to stereotactic body radiation therapy (SBRT) with or without atezolizumab.

SECONDARY OBJECTIVES:

I. To compare investigator-assessed progression-free survival (IA-PFS) between the arms.

II. To compare progression free survival (PFS) by blinded independent centralized review (BIRC) between the arms in a random subset of patients.

III. To evaluate distant, locoregional, and local failure rates within each treatment arm.

IV. To evaluate the frequency and severity of toxicities within each treatment arm.

ADDITIONAL OBJECTIVE:

I. To collect specimens for banking.

HEALTH-RELATED QUALITY OF LIFE (HRQOL) OBJECTIVE:

I. To assess quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ)-30 and EORTC-QLQ- Lung Cancer (LC)13 between the arms.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive atezolizumab intravenously (IV) over 30-60 minutes on day 1 of each cycle. Treatment repeats every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Starting on day 1 cycle 3, patients also undergo SBRT for 3-8 treatments every 2 days or once daily (QD) over 1-3 weeks. Patients undergo fludeoxyglucose F-18 (FDG)-positron emission tomography/computed tomography (PET/CT) during screening. Patients undergo blood sample collection and CT scans throughout the trial.

ARM B: Beginning 21 days after randomization, patients undergo SBRT for 3-8 treatments every 2 days or QD over 1-3 weeks. Patients undergo FDG-PET/CT during screening. Patients undergo blood sample collection and CT scans throughout the trial.

After completion of study treatment, patients are followed for 5 years after randomization.

Eligibility criteria: Inclusion Criteria:

* Patient must have histologically or cytologically proven stage I-IIA or limited T3N0M0 non-small cell lung cancer (NSCLC), without radiographic evidence of nodal or distant involvement (N0M0). Patient may have T3 disease with the exclusion of pericardial involvement. Patients with multifocal tumors with no more than two lesions confirmed or suspected to be synchronous early stage NSCLCs are eligible provided at least one lesion is histologically or cytologically proven to be NSCLC and meets one or more high-risk features
* Disease must have one or more of the following high-risk features:

  * Tumor diameter \>= 2 cm (inclusive of any non-solid, ground glass component) as assessed by diagnostic CT
  * Tumor standard uptake value (SUV) max \>= 6.2 as assessed by FDG PET/CT
  * Moderately differentiated, poorly differentiated, or undifferentiated histology
* Patient must have undergone diagnostic chest CT with or without contrast (IV contrast preferred) within 42 days prior to randomization. PET-CT may be used if the CT portion is of comparable diagnostic quality to a stand-alone CT. All disease must be assessed within 42 days prior to randomization
* Patient must have undergone FDG PET/CT of chest within 90 days prior to randomization
* Patient must not have evidence of hilar or mediastinal nodal involvement. Any patient with radiographically suspicious hilar or mediastinal nodes (including features such as non-calcified nodes with a short axis diameter \> 1 cm, abnormal morphology, and/or elevated FDG avidity) must undergo cytologic sampling of suspicious nodes to rule out involvement prior to randomization. Mediastinal nodal sampling for other patients is optional. For cases in which the treating physician/multidisciplinary opinion is used to define nodes as "non-suspicious" (such as long-standing, stable enlarged nodes from other medical causes), the rationale must be clearly documented within the medical record
* Patient must have undergone history and physical examination within 28 days prior to randomization
* Patient must be medically or surgically inoperable as documented by the evaluating thoracic surgeon or multi-disciplinary tumor board consensus OR patient's unwillingness to undergo surgical resection must be clearly documented
* Patient must not have received any prior treatment for the current NSCLC diagnosis
* Patient must not have undergone prior radiation to overlapping regions of the chest that, in the opinion of the treatment physician, will interfere with protocol treatment
* Patient must not have received treatment with systemic immunostimulatory or immunosuppressive agents, including corticosteroids, within 14 days prior to randomization
* Patient must be \>= 18 years old
* Patient must have Zubrod performance status of 0-2
* Patient must have adequate liver function defined as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3 x institutional upper level of normal (IULN) within 28 days prior to randomization
* Patient must have adequate renal function defined as calculated creatinine clearance \>= 30 mL/min using the following formula. The serum creatinine value used in the calculation must have been collected within 28 days prior to randomization
* Patient must have absolute neutrophil count (ANC), platelets, and hemoglobin measured within 28 days prior to randomization. The purpose of these tests is to collect baseline values to compare with on-treatment values
* Patient must have thyroid-stimulating hormone (TSH) measured within 28 days prior to randomization. The purpose of this test is to collect baseline values to compare with on-treatment values
* Patient must not have significant cardiovascular disease (New York Heart Association \[NYHA\] class II or greater)
* Patient must not have myocardial infarction within 90 days prior to randomization
* Patient must not have unstable arrhythmias or unstable angina
* Patient must not have known left ventricular ejection fraction (LVEF) \< 40% within 28 days prior to randomization

  * NOTE: Assessment of LVEF by echocardiogram or multigated acquisition (MUGA) is not an eligibility requirement, but if a standard of care echocardiogram or MUGA was clinically indicated, the LVEF must not be \< 40% within 28 days prior to randomization
* Patient must not have had an infection \>= grade 3 (Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0) within 28 days prior to randomization
* Patient must not have an active autoimmune disease that has required systemic treatment in past two years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
* Patient must be tested for hepatitis B within 28 days prior to randomization. Patient must not have active (chronic or acute) hepatitis B virus (HBV) infection. Patients may have past or resolved HBV infection

  * Active HBV is defined as having a positive hepatitis B surface antigen (HBsAg) test
  * Past or resolved HBV is defined as having a negative HBsAG test and a positive total hepatitis B core antibody (HBcAb) test
* Patient must be tested for hepatitis C within 28 days prior to randomization. Patient must not have active hepatitis C virus (HCV) infection

  * Active HCV is defined as having a positive HCV antibody test followed by a positive HCV ribonucleic acid (RNA) test
* Patient must have pulmonary function testing to include, at a minimum, forced expiratory volume in 1 second (FEV1) and Diffusing capability of carbon monoxide (DLCO) documented within 90 days prior to randomization
* Patients with known human immunodeficiency virus (HIV) infection must be receiving anti-retroviral therapy and have an undetectable viral load at their most recent viral load test within 6 months prior to randomization
* Patient must not have a history of clinically significant interstitial lung disease or evidence of active pneumonitis on the screening chest CT
* Patients must not have a prior or concurrent malignancy whose natural history or treatment has the potential (in the opinion of the treating physician) to interfere with the safety or efficacy assessment of the investigational regimen
* Patients must not be pregnant due to the potential teratogenic side effects of the protocol treatment. Women of reproductive potential and men must have agreed to use an effective contraception method for the duration of protocol treatment, and for 5 months (150 days) after the last dose of atezolizumab. A woman is considered to be of "reproductive potential" if she has had a menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with atezolizumab, breastfeeding must be discontinued prior to randomization
* Patients of reproductive potential must have a negative serum pregnancy test within 14 days prior to randomization
* Patients must not have known active tuberculosis
* Patients must not have received a live, attenuated vaccine within 28 days prior to randomization

  * NOTE: All coronavirus disease 2019 (COVID-19) vaccines that have received Food and Drug Administration (FDA) approval or FDA emergency use authorization are acceptable
* Patients must not have a known history of allergic reactions attributed to compounds of similar chemical or biologic composition to atezolizumab
* Patients must not have a known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric antibodies, fusion proteins, or Chinese hamster ovary cell products or to any component of the atezolizumab formulation
* Patient must agree to have specimens submitted for translational medicine and banking
* Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
* As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
* Patients who can complete quality of life instruments in English, French, or Spanish must agree to complete the questionnaires at the protocol-specified time points

Primary outcomes:
measure: Overall survival
timeFrame: From date of randomization to date of death due to any cause, assessed up to 3 years
Secondary outcomes:
measure: Progression free survival
timeFrame: From date of randomization to date of first documentation of progression or death due to any cause, assessed up to 5 years
measure: Incidence of adverse events
timeFrame: Up to 5 years
Other outcomes:
measure: Change in health-related quality of life
timeFrame: Up to 5 years
Locations:
city: Anchorage
country: United States
facility: Providence Alaska Medical Center
state: Alaska
city: Jonesboro
country: United States
facility: NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
state: Arkansas
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Antioch
country: United States
facility: Kaiser Permanente-Deer Valley Medical Center
state: California
city: Bakersfield
country: United States
facility: AIS Cancer Center at San Joaquin Community Hospital
state: California
city: Berkeley
country: United States
facility: Alta Bates Summit Medical Center-Herrick Campus
state: California
city: Beverly Hills
country: United States
facility: Tower Cancer Research Foundation
state: California
city: Dublin
country: United States
facility: Kaiser Permanente Dublin
state: California
city: Fremont
country: United States
facility: Kaiser Permanente-Fremont
state: California
city: Fresno
country: United States
facility: Kaiser Permanente-Fresno
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Loma Linda
country: United States
facility: Veterans Affairs Loma Linda Healthcare System
state: California
city: Long Beach
country: United States
facility: Tibor Rubin VA Medical Center
state: California
city: Los Angeles
country: United States
facility: Los Angeles General Medical Center
state: California
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Marysville
country: United States
facility: Fremont - Rideout Cancer Center
state: California
city: Modesto
country: United States
facility: Memorial Medical Center
state: California
city: Modesto
country: United States
facility: Kaiser Permanente-Modesto
state: California
city: Oakland
country: United States
facility: Kaiser Permanente-Oakland
state: California
city: Orange
country: United States
facility: Saint Joseph Hospital - Orange
state: California
city: Orange
country: United States
facility: UC Irvine Health/Chao Family Comprehensive Cancer Center
state: California
city: Palm Springs
country: United States
facility: Desert Regional Medical Center
state: California
city: Richmond
country: United States
facility: Kaiser Permanente-Richmond
state: California
city: Roseville
country: United States
facility: Kaiser Permanente-Roseville
state: California
city: Roseville
country: United States
facility: Sutter Cancer Centers Radiation Oncology Services-Roseville
state: California
city: Roseville
country: United States
facility: Sutter Roseville Medical Center
state: California
city: Roseville
country: United States
facility: The Permanente Medical Group-Roseville Radiation Oncology
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente Downtown Commons
state: California
city: Sacramento
country: United States
facility: Sutter Medical Center Sacramento
state: California
city: Sacramento
country: United States
facility: University of California Davis Comprehensive Cancer Center
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente-South Sacramento
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center-Pacific Campus
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente-San Francisco
state: California
city: San Francisco
country: United States
facility: Veterans Affairs Medical Center - San Francisco
state: California
city: San Jose
country: United States
facility: Kaiser Permanente-Santa Teresa-San Jose
state: California
city: San Leandro
country: United States
facility: Kaiser Permanente San Leandro
state: California
city: San Rafael
country: United States
facility: Kaiser San Rafael-Gallinas
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente Medical Center - Santa Clara
state: California
city: Santa Rosa
country: United States
facility: Kaiser Permanente-Santa Rosa
state: California
city: South San Francisco
country: United States
facility: Kaiser Permanente Cancer Treatment Center
state: California
city: South San Francisco
country: United States
facility: Kaiser Permanente-South San Francisco
state: California
city: Stockton
country: United States
facility: Kaiser Permanente-Stockton
state: California
city: Truckee
country: United States
facility: Gene Upshaw Memorial Tahoe Forest Cancer Center
state: California
city: Vacaville
country: United States
facility: Kaiser Permanente Medical Center-Vacaville
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente-Vallejo
state: California
city: Vallejo
country: United States
facility: Sutter Solano Medical Center/Cancer Center
state: California
city: Walnut Creek
country: United States
facility: Kaiser Permanente-Walnut Creek
state: California
city: Whittier
country: United States
facility: Presbyterian Intercommunity Hospital
state: California
city: Aurora
country: United States
facility: Rocky Mountain Regional VA Medical Center
state: Colorado
city: Aurora
country: United States
facility: UCHealth University of Colorado Hospital
state: Colorado
city: Colorado Springs
country: United States
facility: Penrose-Saint Francis Healthcare
state: Colorado
city: Colorado Springs
country: United States
facility: UCHealth Memorial Hospital Central
state: Colorado
city: Colorado Springs
country: United States
facility: Memorial Hospital North
state: Colorado
city: Denver
country: United States
facility: Kaiser Permanente-Franklin
state: Colorado
city: Fort Collins
country: United States
facility: Poudre Valley Hospital
state: Colorado
city: Fort Collins
country: United States
facility: Cancer Care and Hematology-Fort Collins
state: Colorado
city: Greeley
country: United States
facility: Banner North Colorado Medical Center
state: Colorado
city: Greeley
country: United States
facility: UCHealth Greeley Hospital
state: Colorado
city: Highlands Ranch
country: United States
facility: UCHealth Highlands Ranch Hospital
state: Colorado
city: Lafayette
country: United States
facility: Kaiser Permanente-Rock Creek
state: Colorado
city: Lone Tree
country: United States
facility: Kaiser Permanente-Lone Tree
state: Colorado
city: Loveland
country: United States
facility: Medical Center of the Rockies
state: Colorado
city: Loveland
country: United States
facility: Banner McKee Medical Center
state: Colorado
city: Fairfield
country: United States
facility: Smilow Cancer Hospital Care Center-Fairfield
state: Connecticut
city: Greenwich
country: United States
facility: Smilow Cancer Hospital Care Center at Greenwich
state: Connecticut
city: Guilford
country: United States
facility: Smilow Cancer Hospital Care Center - Guilford
state: Connecticut
city: Hamden
country: United States
facility: Smilow Cancer Hospital-Hamden Care Center
state: Connecticut
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: North Haven
country: United States
facility: Yale-New Haven Hospital North Haven Medical Center
state: Connecticut
city: Trumbull
country: United States
facility: Smilow Cancer Hospital Care Center-Trumbull
state: Connecticut
city: Waterford
country: United States
facility: Smilow Cancer Hospital Care Center - Waterford
state: Connecticut
city: Dover
country: United States
facility: Bayhealth Hospital Kent Campus
state: Delaware
city: Millville
country: United States
facility: Beebe South Coastal Health Campus
state: Delaware
city: Newark
country: United States
facility: Helen F Graham Cancer Center
state: Delaware
city: Newark
country: United States
facility: Medical Oncology Hematology Consultants PA
state: Delaware
city: Rehoboth Beach
country: United States
facility: Beebe Health Campus
state: Delaware
city: Washington
country: United States
facility: George Washington University Medical Center
state: District of Columbia
city: Aventura
country: United States
facility: GenesisCare USA - Aventura FP
state: Florida
city: Aventura
country: United States
facility: GenesisCare USA - Aventura
state: Florida
city: Jupiter
country: United States
facility: Jupiter Medical Center
state: Florida
city: Orlando
country: United States
facility: Orlando Health Cancer Institute
state: Florida
city: Pembroke Pines
country: United States
facility: Memorial Hospital West
state: Florida
city: Plantation
country: United States
facility: GenesisCare USA - Plantation
state: Florida
city: Sarasota
country: United States
facility: Florida Cancer Specialists - Sarasota
state: Florida
city: Sarasota
country: United States
facility: Florida Cancer Specialists - Sarasota Downtown
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Health Care Center at University Parkway
state: Florida
city: Augusta
country: United States
facility: Augusta Oncology Associates PC-D'Antignac
state: Georgia
city: Augusta
country: United States
facility: Augusta University Medical Center
state: Georgia
city: Savannah
country: United States
facility: Memorial Health University Medical Center
state: Georgia
city: Savannah
country: United States
facility: Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
state: Georgia
city: 'Aiea
country: United States
facility: Hawaii Cancer Care - Westridge
state: Hawaii
city: 'Aiea
country: United States
facility: Pali Momi Medical Center
state: Hawaii
city: Honolulu
country: United States
facility: Hawaii Cancer Care Inc - Waterfront Plaza
state: Hawaii
city: Honolulu
country: United States
facility: Queen's Cancer Cenrer - POB I
state: Hawaii
city: Honolulu
country: United States
facility: Queen's Medical Center
state: Hawaii
city: Honolulu
country: United States
facility: Straub Clinic and Hospital
state: Hawaii
city: Honolulu
country: United States
facility: Queen's Cancer Center - Kuakini
state: Hawaii
city: Honolulu
country: United States
facility: The Cancer Center of Hawaii-Liliha
state: Hawaii
city: Boise
country: United States
facility: Saint Alphonsus Cancer Care Center-Boise
state: Idaho
city: Caldwell
country: United States
facility: Saint Alphonsus Cancer Care Center-Caldwell
state: Idaho
city: Nampa
country: United States
facility: Saint Alphonsus Cancer Care Center-Nampa
state: Idaho
city: Aurora
country: United States
facility: Rush - Copley Medical Center
state: Illinois
city: Bloomington
country: United States
facility: OSF Saint Joseph Medical Center
state: Illinois
city: Bloomington
country: United States
facility: Illinois CancerCare-Bloomington
state: Illinois
city: Canton
country: United States
facility: Illinois CancerCare-Canton
state: Illinois
city: Carthage
country: United States
facility: Illinois CancerCare-Carthage
state: Illinois
city: Chicago
country: United States
facility: Jesse Brown Veterans Affairs Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Illinois
state: Illinois
city: Decatur
country: United States
facility: Decatur Memorial Hospital
state: Illinois
city: Effingham
country: United States
facility: Crossroads Cancer Center
state: Illinois
city: Eureka
country: United States
facility: Illinois CancerCare-Eureka
state: Illinois
city: Galesburg
country: United States
facility: Illinois CancerCare-Galesburg
state: Illinois
city: Galesburg
country: United States
facility: Western Illinois Cancer Treatment Center
state: Illinois
city: Kewanee
country: United States
facility: Illinois CancerCare-Kewanee Clinic
state: Illinois
city: Macomb
country: United States
facility: Illinois CancerCare-Macomb
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Ottawa
country: United States
facility: Illinois CancerCare-Ottawa Clinic
state: Illinois
city: Pekin
country: United States
facility: Illinois CancerCare-Pekin
state: Illinois
city: Peoria
country: United States
facility: Illinois CancerCare-Peoria
state: Illinois
city: Peoria
country: United States
facility: OSF Saint Francis Radiation Oncology at Peoria Cancer Center
state: Illinois
city: Peoria
country: United States
facility: Methodist Medical Center of Illinois
state: Illinois
city: Peoria
country: United States
facility: OSF Saint Francis Medical Center
state: Illinois
city: Peru
country: United States
facility: Illinois CancerCare-Peru
state: Illinois
city: Princeton
country: United States
facility: Illinois CancerCare-Princeton
state: Illinois
city: Rockford
country: United States
facility: UW Health Carbone Cancer Center Rockford
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic
state: Illinois
city: Springfield
country: United States
facility: Springfield Memorial Hospital
state: Illinois
city: Urbana
country: United States
facility: Carle Cancer Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University/Melvin and Bren Simon Cancer Center
state: Indiana
city: Indianapolis
country: United States
facility: Community Cancer Center South
state: Indiana
city: Ames
country: United States
facility: McFarland Clinic - Ames
state: Iowa
city: Clive
country: United States
facility: Mercy Cancer Center-West Lakes
state: Iowa
city: Clive
country: United States
facility: UI Health Care Mission Cancer and Blood - West Des Moines Clinic
state: Iowa
city: Creston
country: United States
facility: Greater Regional Medical Center
state: Iowa
city: Des Moines
country: United States
facility: Mercy Medical Center - Des Moines
state: Iowa
city: Des Moines
country: United States
facility: UI Health Care Mission Cancer and Blood - Laurel Clinic
state: Iowa
city: West Des Moines
country: United States
facility: Mercy Medical Center-West Lakes
state: Iowa
city: Wichita
country: United States
facility: Ascension Via Christi Hospitals Wichita
state: Kansas
city: Lexington
country: United States
facility: Saint Joseph Hospital East
state: Kentucky
city: Baton Rouge
country: United States
facility: LSU Health Baton Rouge-North Clinic
state: Louisiana
city: Baton Rouge
country: United States
facility: Our Lady of the Lake Physician Group
state: Louisiana
city: Baton Rouge
country: United States
facility: Louisiana Hematology Oncology Associates LLC
state: Louisiana
city: Baton Rouge
country: United States
facility: Mary Bird Perkins Cancer Center
state: Louisiana
city: Houma
country: United States
facility: Mary Bird Perkins Cancer Center - Houma
state: Louisiana
city: Houma
country: United States
facility: Terrebonne General Medical Center
state: Louisiana
city: Metairie
country: United States
facility: East Jefferson General Hospital
state: Louisiana
city: Towson
country: United States
facility: UM Saint Joseph Medical Center
state: Maryland
city: Beverly
country: United States
facility: Beverly Hospital
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Hospital and Medical Center
state: Massachusetts
city: Gloucester
country: United States
facility: Addison Gilbert Hospital
state: Massachusetts
city: Winchester
country: United States
facility: Beth Israel Deaconess Medical Center/Winchester Center for Cancer Care
state: Massachusetts
city: Ann Arbor
country: United States
facility: Trinity Health Saint Joseph Mercy Hospital Ann Arbor
state: Michigan
city: Brighton
country: United States
facility: Trinity Health Medical Center - Brighton
state: Michigan
city: Canton
country: United States
facility: Trinity Health Medical Center - Canton
state: Michigan
city: Chelsea
country: United States
facility: Chelsea Hospital
state: Michigan
city: Clarkston
country: United States
facility: Michigan Healthcare Professionals Clarkston
state: Michigan
city: Dearborn
country: United States
facility: Corewell Health Dearborn Hospital
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health Saint John Hospital
state: Michigan
city: Farmington Hills
country: United States
facility: Michigan Healthcare Professionals Farmington
state: Michigan
city: Farmington Hills
country: United States
facility: Corewell Health Farmington Hills Hospital
state: Michigan
city: Flint
country: United States
facility: Genesys Hurley Cancer Institute
state: Michigan
city: Kalamazoo
country: United States
facility: West Michigan Cancer Center
state: Michigan
city: Lansing
country: United States
facility: University of Michigan Health - Sparrow Lansing
state: Michigan
city: Livonia
country: United States
facility: Trinity Health Saint Mary Mercy Livonia Hospital
state: Michigan
city: Macomb
country: United States
facility: Michigan Healthcare Professionals Macomb
state: Michigan
city: Niles
country: United States
facility: Corewell Health Lakeland Hospitals - Niles Hospital
state: Michigan
city: Novi
country: United States
facility: Henry Ford Health Providence Novi Hospital
state: Michigan
city: Pontiac
country: United States
facility: Michigan Healthcare Professionals Pontiac
state: Michigan
city: Pontiac
country: United States
facility: Trinity Health Saint Joseph Mercy Oakland Hospital
state: Michigan
city: Royal Oak
country: United States
facility: Corewell Health William Beaumont University Hospital
state: Michigan
city: Saginaw
country: United States
facility: MyMichigan Medical Center Saginaw
state: Michigan
city: Saginaw
country: United States
facility: Oncology Hematology Associates of Saginaw Valley PC
state: Michigan
city: Saint Joseph
country: United States
facility: Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
state: Michigan
city: Saint Joseph
country: United States
facility: Corewell Health Lakeland Hospitals - Saint Joseph Hospital
state: Michigan
city: Southfield
country: United States
facility: Henry Ford Health Providence Southfield Hospital
state: Michigan
city: Tawas City
country: United States
facility: MyMichigan Medical Center Tawas
state: Michigan
city: Traverse City
country: United States
facility: Munson Medical Center
state: Michigan
city: Troy
country: United States
facility: Corewell Health Beaumont Troy Hospital
state: Michigan
city: Troy
country: United States
facility: Michigan Healthcare Professionals Troy
state: Michigan
city: Warren
country: United States
facility: Henry Ford Health Warren Hospital
state: Michigan
city: West Branch
country: United States
facility: Saint Mary's Oncology/Hematology Associates of West Branch
state: Michigan
city: Wyoming
country: United States
facility: University of Michigan Health - West
state: Michigan
city: Bemidji
country: United States
facility: Sanford Joe Lueken Cancer Center
state: Minnesota
city: Duluth
country: United States
facility: Miller-Dwan Hospital
state: Minnesota
city: Minneapolis
country: United States
facility: Abbott-Northwestern Hospital
state: Minnesota
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Saint Cloud
country: United States
facility: Coborn Cancer Center at Saint Cloud Hospital
state: Minnesota
city: Saint Louis Park
country: United States
facility: Park Nicollet Clinic - Saint Louis Park
state: Minnesota
city: Saint Paul
country: United States
facility: Regions Hospital
state: Minnesota
city: Columbus
country: United States
facility: Baptist Memorial Hospital and Cancer Center-Golden Triangle
state: Mississippi
city: Grenada
country: United States
facility: Baptist Cancer Center-Grenada
state: Mississippi
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: New Albany
country: United States
facility: Baptist Memorial Hospital and Cancer Center-Union County
state: Mississippi
city: Oxford
country: United States
facility: Baptist Memorial Hospital and Cancer Center-Oxford
state: Mississippi
city: Southhaven
country: United States
facility: Baptist Memorial Hospital and Cancer Center-Desoto
state: Mississippi
city: Cape Girardeau
country: United States
facility: Saint Francis Medical Center
state: Missouri
city: Farmington
country: United States
facility: Parkland Health Center - Farmington
state: Missouri
city: Joplin
country: United States
facility: Freeman Health System
state: Missouri
city: Kansas City
country: United States
facility: Kansas City Veterans Affairs Medical Center
state: Missouri
city: Rolla
country: United States
facility: Phelps Health Delbert Day Cancer Institute
state: Missouri
city: Saint Joseph
country: United States
facility: Heartland Regional Medical Center
state: Missouri
city: Saint Louis
country: United States
facility: Missouri Baptist Medical Center
state: Missouri
city: Sainte Genevieve
country: United States
facility: Sainte Genevieve County Memorial Hospital
state: Missouri
city: Springfield
country: United States
facility: Mercy Hospital Springfield
state: Missouri
city: Springfield
country: United States
facility: CoxHealth South Hospital
state: Missouri
city: Sullivan
country: United States
facility: Missouri Baptist Sullivan Hospital
state: Missouri
city: Sunset Hills
country: United States
facility: BJC Outpatient Center at Sunset Hills
state: Missouri
city: Billings
country: United States
facility: Billings Clinic Cancer Center
state: Montana
city: Bozeman
country: United States
facility: Bozeman Health Deaconess Hospital
state: Montana
city: Butte
country: United States
facility: Saint James Community Hospital and Cancer Treatment Center
state: Montana
city: Great Falls
country: United States
facility: Benefis Sletten Cancer Institute
state: Montana
city: Bellevue
country: United States
facility: Nebraska Medicine-Bellevue
state: Nebraska
city: Grand Island
country: United States
facility: Nebraska Cancer Specialists/Oncology Hematology West PC
state: Nebraska
city: Kearney
country: United States
facility: CHI Health Good Samaritan
state: Nebraska
city: Omaha
country: United States
facility: Nebraska Medicine-Village Pointe
state: Nebraska
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge
state: New Jersey
city: Camden
country: United States
facility: Cooper Hospital University Medical Center
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen
state: New Jersey
city: Pennington
country: United States
facility: Capital Health Medical Center-Hopewell
state: New Jersey
city: Voorhees
country: United States
facility: MD Anderson Cancer Center at Cooper-Voorhees
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Center
state: New Mexico
city: Bronx
country: United States
facility: Montefiore Medical Center-Einstein Campus
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center - Moses Campus
state: New York
city: Brooklyn
country: United States
facility: New York-Presbyterian/Brooklyn Methodist Hospital
state: New York
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack
state: New York
city: Cooperstown
country: United States
facility: Mary Imogene Bassett Hospital
state: New York
city: East Hills
country: United States
facility: The Cancer Institute at Saint Francis Hospital
state: New York
city: Elmira
country: United States
facility: Arnot Ogden Medical Center/Falck Cancer Center
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: Lake Success
country: United States
facility: Northwell Health/Center for Advanced Medicine
state: New York
city: New York
country: United States
facility: Mount Sinai Chelsea
state: New York
city: New York
country: United States
facility: Mount Sinai West
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: Manhattan Eye Ear and Throat Hospital
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Syracuse
country: United States
facility: State University of New York Upstate Medical University
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau
state: New York
city: West Islip
country: United States
facility: Good Samaritan University Hospital
state: New York
city: Asheville
country: United States
facility: Messino Cancer Centers
state: North Carolina
city: Cary
country: United States
facility: Rex Hematology Oncology Associates-Cary
state: North Carolina
city: Charlotte
country: United States
facility: Novant Health Presbyterian Medical Center
state: North Carolina
city: Durham
country: United States
facility: Durham VA Medical Center
state: North Carolina
city: Garner
country: United States
facility: Rex Hematology Oncology Associates-Garner
state: North Carolina
city: Gastonia
country: United States
facility: CaroMont Regional Medical Center
state: North Carolina
city: Hendersonville
country: United States
facility: Margaret R Pardee Memorial Hospital
state: North Carolina
city: Huntersville
country: United States
facility: Novant Health Cancer Institute - Huntersville
state: North Carolina
city: Kernersville
country: United States
facility: Novant Health Cancer Institute - Kernersville
state: North Carolina
city: Matthews
country: United States
facility: Novant Health Cancer Institute - Matthews
state: North Carolina
city: New Bern
country: United States
facility: CarolinaEast Medical Center
state: North Carolina
city: Pinehurst
country: United States
facility: FirstHealth of the Carolinas-Moore Regional Hospital
state: North Carolina
city: Raleigh
country: United States
facility: UNC Rex Healthcare
state: North Carolina
city: Raleigh
country: United States
facility: UNC Rex Cancer Center of Wakefield
state: North Carolina
city: Supply
country: United States
facility: Novant Cancer Institute Radiation Oncology - Supply
state: North Carolina
city: Wilmington
country: United States
facility: Novant Health Cancer Institute Radiation Oncology - Wilmington
state: North Carolina
city: Wilmington
country: United States
facility: Novant Health New Hanover Regional Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Novant Health Forsyth Medical Center
state: North Carolina
city: Bismarck
country: United States
facility: Sanford Bismarck Medical Center
state: North Dakota
city: Fargo
country: United States
facility: Sanford Broadway Medical Center
state: North Dakota
city: Fargo
country: United States
facility: Sanford Roger Maris Cancer Center
state: North Dakota
city: Centerville
country: United States
facility: Miami Valley Hospital South
state: Ohio
city: Chillicothe
country: United States
facility: Adena Regional Medical Center
state: Ohio
city: Cincinnati
country: United States
facility: Good Samaritan Hospital - Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
city: Columbus
country: United States
facility: The Mark H Zangmeister Center
state: Ohio
city: Dayton
country: United States
facility: Miami Valley Hospital
state: Ohio
city: Dayton
country: United States
facility: Premier Blood and Cancer Center
state: Ohio
city: Dayton
country: United States
facility: Miami Valley Hospital North
state: Ohio
city: Franklin
country: United States
facility: Atrium Medical Center-Middletown Regional Hospital
state: Ohio
city: Grove City
country: United States
facility: Mount Carmel Grove City Hospital
state: Ohio
city: Troy
country: United States
facility: Upper Valley Medical Center
state: Ohio
city: Westerville
country: United States
facility: Saint Ann's Hospital
state: Ohio
city: Zanesville
country: United States
facility: Genesis Healthcare System Cancer Care Center
state: Ohio
city: Lawton
country: United States
facility: Cancer Centers of Southwest Oklahoma Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: Mercy Hospital Oklahoma City
state: Oklahoma
city: Clackamas
country: United States
facility: Clackamas Radiation Oncology Center
state: Oregon
city: Gresham
country: United States
facility: Legacy Mount Hood Medical Center
state: Oregon
city: Portland
country: United States
facility: Legacy Good Samaritan Hospital and Medical Center
state: Oregon
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Portland
country: United States
facility: Providence Saint Vincent Medical Center
state: Oregon
city: Tualatin
country: United States
facility: Legacy Meridian Park Hospital
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Hospital-Cedar Crest
state: Pennsylvania
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Drexel Hill
country: United States
facility: Delaware County Memorial Hospital
state: Pennsylvania
city: East Stroudsburg
country: United States
facility: Pocono Medical Center
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Milton S Hershey Medical Center
state: Pennsylvania
city: Indiana
country: United States
facility: IRMC Cancer Center
state: Pennsylvania
city: Lewisburg
country: United States
facility: Geisinger Medical Oncology-Lewisburg
state: Pennsylvania
city: Monroeville
country: United States
facility: UPMC Cancer Center - Monroeville
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Jefferson Torresdale Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC-Saint Margaret
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Cancer Institute (UPCI)
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC-Shadyside Hospital
state: Pennsylvania
city: Pottsville
country: United States
facility: Geisinger Cancer Services-Pottsville
state: Pennsylvania
city: Selinsgrove
country: United States
facility: Geisinger Medical Oncology-Selinsgrove
state: Pennsylvania
city: West Reading
country: United States
facility: Reading Hospital
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Geisinger Wyoming Valley/Henry Cancer Center
state: Pennsylvania
city: Willow Grove
country: United States
facility: Asplundh Cancer Pavilion
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Bluffton
country: United States
facility: Saint Joseph's/Candler - Bluffton Campus
state: South Carolina
city: Florence
country: United States
facility: McLeod Regional Medical Center
state: South Carolina
city: Gaffney
country: United States
facility: Gibbs Cancer Center-Gaffney
state: South Carolina
city: Greenville
country: United States
facility: Saint Francis Hospital
state: South Carolina
city: Greenville
country: United States
facility: Saint Francis Cancer Center
state: South Carolina
city: Greer
country: United States
facility: Gibbs Cancer Center-Pelham
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Center
state: South Carolina
city: Sioux Falls
country: United States
facility: Sanford Cancer Center Oncology Clinic
state: South Dakota
city: Sioux Falls
country: United States
facility: Sanford USD Medical Center - Sioux Falls
state: South Dakota
city: Collierville
country: United States
facility: Baptist Memorial Hospital and Cancer Center-Collierville
state: Tennessee
city: Kingsport
country: United States
facility: Ballad Health Cancer Care - Kingsport
state: Tennessee
city: Kingsport
country: United States
facility: Wellmont Holston Valley Hospital and Medical Center
state: Tennessee
city: Memphis
country: United States
facility: Baptist Memorial Hospital and Cancer Center-Memphis
state: Tennessee
city: Conroe
country: United States
facility: MD Anderson in The Woodlands
state: Texas
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: MD Anderson West Houston
state: Texas
city: League City
country: United States
facility: MD Anderson League City
state: Texas
city: Sugar Land
country: United States
facility: MD Anderson in Sugar Land
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute/University of Utah
state: Utah
city: Salt Lake City
country: United States
facility: George E Wahlen Department of Veterans Affairs Medical Center
state: Utah
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute
state: Virginia
city: Fishersville
country: United States
facility: Augusta Health Center for Cancer and Blood Disorders
state: Virginia
city: Norton
country: United States
facility: Ballad Health Cancer Care - Norton
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Vancouver
country: United States
facility: Legacy Cancer Institute Medical Oncology and Day Treatment
state: Washington
city: Vancouver
country: United States
facility: Legacy Salmon Creek Hospital
state: Washington
city: Charleston
country: United States
facility: West Virginia University Charleston Division
state: West Virginia
city: Huntington
country: United States
facility: Edwards Comprehensive Cancer Center
state: West Virginia
city: Wheeling
country: United States
facility: Wheeling Hospital/Schiffler Cancer Center
state: West Virginia
city: Antigo
country: United States
facility: Langlade Hospital and Cancer Center
state: Wisconsin
city: Appleton
country: United States
facility: ThedaCare Regional Cancer Center
state: Wisconsin
city: Appleton
country: United States
facility: Ascension Saint Elizabeth Hospital
state: Wisconsin
city: Ashland
country: United States
facility: Northwest Wisconsin Cancer Center
state: Wisconsin
city: Brookfield
country: United States
facility: Ascension Southeast Wisconsin Hospital - Elmbrook Campus
state: Wisconsin
city: Burlington
country: United States
facility: Aurora Cancer Care-Southern Lakes VLCC
state: Wisconsin
city: Chilton
country: United States
facility: Ascension Calumet Hospital
state: Wisconsin
city: Eau Claire
country: United States
facility: HSHS Sacred Heart Hospital
state: Wisconsin
city: Eau Claire
country: United States
facility: Marshfield Medical Center-EC Cancer Center
state: Wisconsin
city: Franklin
country: United States
facility: Ascension Saint Francis - Reiman Cancer Center
state: Wisconsin
city: Germantown
country: United States
facility: Aurora Health Care Germantown Health Center
state: Wisconsin
city: Grafton
country: United States
facility: Aurora Cancer Care-Grafton
state: Wisconsin
city: Green Bay
country: United States
facility: Bellin Memorial Hospital
state: Wisconsin
city: Green Bay
country: United States
facility: Saint Vincent Hospital Cancer Center Green Bay
state: Wisconsin
city: Green Bay
country: United States
facility: Saint Vincent Hospital Cancer Center at Saint Mary's
state: Wisconsin
city: Green Bay
country: United States
facility: Aurora BayCare Medical Center
state: Wisconsin
city: Kenosha
country: United States
facility: Aurora Cancer Care-Kenosha South
state: Wisconsin
city: La Crosse
country: United States
facility: Gundersen Lutheran Medical Center
state: Wisconsin
city: La Crosse
country: United States
facility: Mayo Clinic Health System-Franciscan Healthcare
state: Wisconsin
city: Madison
country: United States
facility: William S Middleton VA Medical Center
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center - University Hospital
state: Wisconsin
city: Marinette
country: United States
facility: Aurora Bay Area Medical Group-Marinette
state: Wisconsin
city: Marshfield
country: United States
facility: Marshfield Medical Center-Marshfield
state: Wisconsin
city: Medford
country: United States
facility: Aspirus Medford Hospital
state: Wisconsin
city: Mequon
country: United States
facility: Ascension Columbia Saint Mary's Hospital Ozaukee
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora Cancer Care-Milwaukee
state: Wisconsin
city: Milwaukee
country: United States
facility: Ascension Columbia Saint Mary's Hospital - Milwaukee
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora Saint Luke's Medical Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora Sinai Medical Center
state: Wisconsin
city: Minocqua
country: United States
facility: Marshfield Medical Center - Minocqua
state: Wisconsin
city: Mukwonago
country: United States
facility: ProHealth D N Greenwald Center
state: Wisconsin
city: New London
country: United States
facility: ThedaCare Cancer Care - New London
state: Wisconsin
city: Oconomowoc
country: United States
facility: ProHealth Oconomowoc Memorial Hospital
state: Wisconsin
city: Oshkosh
country: United States
facility: Ascension Mercy Hospital
state: Wisconsin
city: Oshkosh
country: United States
facility: Vince Lombardi Cancer Clinic - Oshkosh
state: Wisconsin
city: Racine
country: United States
facility: Ascension All Saints Hospital
state: Wisconsin
city: Racine
country: United States
facility: Aurora Cancer Care-Racine
state: Wisconsin
city: Rhinelander
country: United States
facility: Aspirus Cancer Care - James Beck Cancer Center
state: Wisconsin
city: Rice Lake
country: United States
facility: Marshfield Medical Center-Rice Lake
state: Wisconsin
city: Sheboygan
country: United States
facility: Saint Vincent Hospital Cancer Center at Sheboygan
state: Wisconsin
city: Sheboygan
country: United States
facility: Vince Lombardi Cancer Clinic-Sheboygan
state: Wisconsin
city: Stevens Point
country: United States
facility: Aspirus Cancer Care - Stevens Point
state: Wisconsin
city: Stevens Point
country: United States
facility: Marshfield Medical Center-River Region at Stevens Point
state: Wisconsin
city: Sturgeon Bay
country: United States
facility: Saint Vincent Hospital Cancer Center at Sturgeon Bay
state: Wisconsin
city: Summit
country: United States
facility: Aurora Medical Center in Summit
state: Wisconsin
city: Two Rivers
country: United States
facility: Vince Lombardi Cancer Clinic-Two Rivers
state: Wisconsin
city: Waukesha
country: United States
facility: UW Cancer Center at ProHealth Care
state: Wisconsin
city: Wausau
country: United States
facility: Aspirus Regional Cancer Center
state: Wisconsin
city: Wauwatosa
country: United States
facility: Ascension Medical Group Southeast Wisconsin - Mayfair Road
state: Wisconsin
city: Wauwatosa
country: United States
facility: Aurora Cancer Care-Milwaukee West
state: Wisconsin
city: West Allis
country: United States
facility: Aurora West Allis Medical Center
state: Wisconsin
city: Weston
country: United States
facility: Marshfield Medical Center - Weston
state: Wisconsin
city: Wisconsin Rapids
country: United States
facility: Aspirus Cancer Care - Wisconsin Rapids
state: Wisconsin
Study officials:
affiliation: SWOG Cancer Research Network
name: Megan E Daly
role: PRINCIPAL_INVESTIGATOR
References: