Clinical trial NCT04251052: A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Official title: A Non-Randomized Prospective Clinical Trial Comparing the Non-Inferiority of Salpingectomy to Salpingo-oophorectomy to Reduce the Risk of Ovarian Cancer Among BRCA1 Carriers [SOROCk]
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ovarian Carcinoma
Lead sponsor: NRG Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-01-31
Enrollment: 2262
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a non-randomized prospective trial to determine if bilateral salpingectomy (BLS) is non-inferior to bilateral salpingo-oophorectomy (BSO) in terms ovarian, primary peritoneal, and fallopian tube cancer risk among gBRCA1m carriers between 35 and 50 years old. Individuals choose the treatment they want to receive in collaboration with their physician(s).
Primary purpose: PREVENTION

Brief summary: This clinical trial evaluates how well two surgical procedures (bilateral salpingectomy and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for individuals with BRCA1 mutations. Bilateral salpingectomy involves the surgical removal of fallopian tubes, and bilateral salpingo-oophorectomy involves the surgical removal of both the fallopian tubes and ovaries. This study may help doctors determine if the two surgical procedures are nearly the same for ovarian cancer risk reduction for women with BRCA1 mutations.

Detailed description: PRIMARY OBJECTIVE:

I. To compare the non-inferiority of bilateral salpingectomy (BLS) with delayed oophorectomy to bilateral salpingo-oophorectomy (BSO) to reduce the risk of ovarian cancer among individuals with deleterious BRCA1 germline mutations.

SECONDARY OBJECTIVES:

I. To prospectively assess estrogen deprivation symptoms in pre-menopausal BLS patients as measured by the Functional Assessment of Cancer Therapy - Endocrine Symptom (FACT-ES) subscale compared to pre-menopausal patients in the BSO arm.

II. To determine if health-related quality of life (QOL) (FACT) is negatively impacted by menopausal symptoms (menopausal symptom checklist-Menopausal Symptom Checklist \[MSCL\]) and sexual dysfunction (Female Sexual Function Index \[FSFI\]) in pre-menopausal patients who have undergone BLS, in comparison to normative data (MSCL/FACT-ES) and data from pre-menopausal BSO patients.

III. To determine if health-related QOL (FACT) is negatively impacted by cancer distress (Impact of Event Scale \[IES\]) in individuals who have undergone BLS, in comparison to BSO patients.

IV. To assess medical decision making, as measured by the Shared Decision Making Questionnaire (SDM-Q-9) and Decision Regret Scale (DRS), and determine factors associated with the risk of reducing surgical treatment choice.

V. To assess adverse events, graded using Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0.

EXPLORATORY OBJECTIVES:

I. Sexual dysfunction, as measured by selected Patient-Reported Outcomes Measurement Information System (PROMIS) screener and external sexual function items (pre-menopausal patients).

II. To estimate the cost-effectiveness of BLS compared to BSO for ovarian cancer risk reduction.

III. To assess medical decision making, as measured by the Risk-Reducing Medical Decision Making (RR-MDM) survey, a targeted set of questions on risk reducing surgical treatment choice.

TRANSLATIONAL RESEARCH OBJECTIVE:

I. To bank tissue and blood biospecimens for future research.

OUTLINE: Patients choose between 1 of 2 groups.

GROUP I: Patients undergo bilateral salpingectomy. Patients may then undergo oophorectomy after initial surgery.

GROUP II: Patients undergo bilateral salpingo-oophorectomy.

Patients in both groups also undergo a pelvic or transvaginal ultrasound during screening and blood sample collection throughout the trial.

After completion of study, patients are followed up at 10-60 days, 6, 12, and 24 months, and then annually for up to 20 years.

Eligibility criteria: Inclusion Criteria:

* Individuals 35-50 years of age, inclusive
* Patients who will undergo risk-reducing salpingo-oophorectomy (RRSO) (for the BSO arm) and patients who have declined or elected to defer BSO after proper counselling to clearly explain the standard of care for BRCA1 mutation carriers and are undergoing salpingectomy (for the BLS arm with delayed oophorectomy arm). Concurrently planned hysterectomy with either arm is permitted
* At least one intact ovary and fallopian tube is in situ at the time of counseling, consent, and registration. Prior hysterectomy is allowed provided it did not include bilateral salpingectomy. Prior tubal ligation is allowed if one ovary and fallopian tube (with fimbria not removed) are present
* Positive Clinical Laboratory Improvement Act (CLIA)-approved test results for pathogenic or likely pathogenic germline BRCA1 mutation in the patient. Documentation of the result is required
* Patients may be premenopausal or menopausal
* Pelvic ultrasound (transvaginal imaging preferred, but transabdominal imaging is acceptable) and CA-125 within 180 days of registration
* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
* Individuals who are currently pregnant or plan to become pregnant in the future through assisted reproductive technologies and who have received proper counseling are eligible. Individuals who are currently pregnant and plan bilateral salpingectomy at the time of a planned cesarean section are eligible. Patients must understand that they will not be able to become pregnant naturally in the future

Exclusion Criteria:

* Individuals with a history of any prior cancer who have received cytotoxic chemotherapy within the past 30 days or radiotherapy to abdomen or pelvis at any prior time. Endocrine therapy or maintenance ERBB2/HER2 targeted therapy is allowed. Maintenance immune checkpoint inhibitor therapy is allowed. Maintenance therapy with PARP in inhibitor is allowed.
* Prior history of ovarian cancer, including low malignant potential neoplasms (LMP), primary peritoneal carcinoma, or fallopian tube carcinoma
* Patients medically unfit for the planned surgical procedure
* Patients with abnormal screening tests (pelvic ultrasound, CA-125) suspicious for occult or gross pelvic malignancy within the past 180 days

  * An abnormal pelvic ultrasound is defined as morphologic or structural variations suspicious for ovarian malignancy. Complex cystic lesions felt to represent a benign lesion are not exclusionary. Simple cysts of any size are not exclusionary
  * An abnormal CA-125 is defined as a level \> 50U/ml in premenopausal individuals if they are not current users of oral contraceptives; an abnormal CA-125 is defined as a level \> 40U/ml for premenopausal individuals who are current users of oral contraceptives (Skates 2011). An abnormal CA-125 is defined as a level \> 35 U/ml in postmenopausal individuals

Primary outcomes:
measure: Time to development of incident high-grade serous carcinomas (HGSC), specifically ovarian, primary peritoneal, or fallopian tube cancers
timeFrame: Up to 20 years
Secondary outcomes:
measure: Health-related quality of life (QOL)
timeFrame: Up to 24 months post-surgery
measure: Cancer distress
timeFrame: Up to 24 months post-surgery
measure: Medical decision making
timeFrame: Up to 24 months post-surgery
measure: Incidence of adverse events
timeFrame: Up to 20 years
measure: Estrogen deprivation symptoms (pre-menopaused patients only)
timeFrame: Up to 24 months post-surgery
measure: Sexual dysfunction (pre-menopausal patients only)
timeFrame: Up to 24 months post-surgery
measure: Menopausal symptoms (pre-menopausal patients only)
timeFrame: Up to 24 months post-surgery
Other outcomes:
measure: Cost effectiveness
timeFrame: Up to 24 months post-surgery
measure: Section dysfunction (pre-menopausal patients only)
timeFrame: Up to 24 months-post surgery
measure: Health related (HR)-QOL
timeFrame: Up to 24 months post-surgery
measure: Risk-reducing medical decision making validation and assessment
timeFrame: Up to 24 months post-surgery
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Cancer Center
state: Alabama
city: Anchorage
country: United States
facility: Anchorage Associates in Radiation Medicine
state: Alaska
city: Anchorage
country: United States
facility: Anchorage Radiation Therapy Center
state: Alaska
city: Anchorage
country: United States
facility: Alaska Breast Care and Surgery LLC
state: Alaska
city: Anchorage
country: United States
facility: Alaska Oncology and Hematology LLC
state: Alaska
city: Anchorage
country: United States
facility: Alaska Women's Cancer Care
state: Alaska
city: Anchorage
country: United States
facility: Katmai Oncology Group
state: Alaska
city: Anchorage
country: United States
facility: Providence Alaska Medical Center
state: Alaska
city: Goodyear
country: United States
facility: CTCA at Western Regional Medical Center
state: Arizona
city: Tucson
country: United States
facility: Banner University Medical Center - Tucson
state: Arizona
city: Tucson
country: United States
facility: University of Arizona Cancer Center-North Campus
state: Arizona
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: Beverly Hills
country: United States
facility: Tower Cancer Research Foundation
state: California
city: Buena Park
country: United States
facility: Keck Medicine of USC Buena Park
state: California
city: Burbank
country: United States
facility: Providence Saint Joseph Medical Center/Disney Family Cancer Center
state: California
city: Duarte
country: United States
facility: City of Hope Comprehensive Cancer Center
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: Fresno Cancer Center
state: California
city: Fresno
country: United States
facility: Kaiser Permanente-Fresno
state: California
city: Huntington Beach
country: United States
facility: City of Hope Seacliff
state: California
city: Huntington Beach
country: United States
facility: Keck Medicine of USC Huntington Beach
state: California
city: Irvine
country: United States
facility: City of Hope at Irvine Lennar
state: California
city: Irvine
country: United States
facility: Kaiser Permanente-Irvine
state: California
city: Lancaster
country: United States
facility: City of Hope Antelope Valley
state: California
city: Los Angeles
country: United States
facility: Keck Medicine of USC Koreatown
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente Los Angeles 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: Los Angeles
country: United States
facility: UCLA / Jonsson Comprehensive Cancer Center
state: California
city: Modesto
country: United States
facility: Kaiser Permanente-Modesto
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city: Napa
country: United States
facility: Providence Queen of The Valley
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city: Newport Beach
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facility: USC Norris Oncology/Hematology-Newport Beach
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facility: Kaiser Permanente Oakland-Broadway
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facility: Kaiser Permanente - Panorama City
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city: Pasadena
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facility: Keck Medical Center of USC Pasadena
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facility: Kaiser Permanente-Rancho Cordova Cancer Center
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facility: Kaiser Permanente- Marshall Medical Offices
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facility: Kaiser Permanente-Redwood City
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facility: Kaiser Permanente-Richmond
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facility: Kaiser Permanente-Riverside
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facility: Rohnert Park Cancer Center
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facility: The Permanente Medical Group-Roseville Radiation Oncology
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facility: University of California Davis Comprehensive Cancer Center
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facility: UCSF Medical Center-Mission Bay
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facility: Kaiser Permanente-Santa Teresa-San Jose
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facility: Kaiser Permanente San Leandro
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facility: Kaiser San Rafael-Gallinas
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facility: Kaiser Permanente Medical Center - Santa Clara
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facility: Kaiser Permanente-Santa Rosa
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city: Santa Rosa
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facility: Providence Medical Foundation - Santa Rosa
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facility: Providence Santa Rosa Memorial Hospital
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facility: City of Hope South Pasadena
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city: South San Francisco
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facility: Kaiser Permanente Cancer Treatment Center
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city: South San Francisco
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facility: Kaiser Permanente-South San Francisco
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city: Stockton
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facility: Kaiser Permanente-Stockton
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city: Torrance
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facility: City of Hope South Bay
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city: Torrance
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facility: Torrance Memorial Physician Network - Cancer Care
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city: Upland
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facility: City of Hope Upland
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city: Vacaville
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facility: Kaiser Permanente Medical Center-Vacaville
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city: Vallejo
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facility: Kaiser Permanente-Vallejo
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city: Walnut Creek
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facility: Kaiser Permanente-Walnut Creek
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city: Aurora
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facility: UCHealth University of Colorado Hospital
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facility: Penrose-Saint Francis Healthcare
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facility: Delaware Clinical and Laboratory Physicians PA
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facility: Helen F Graham Cancer Center
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facility: Medical Oncology Hematology Consultants PA
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facility: Christiana Care Health System-Christiana Hospital
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city: Rehoboth Beach
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facility: Beebe Health Campus
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facility: Christiana Care Health System-Wilmington Hospital
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city: Washington
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facility: George Washington University Medical Center
state: District of Columbia
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facility: UM Sylvester Comprehensive Cancer Center at Aventura
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facility: Florida Cancer Specialists - Bradenton Cancer Center
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facility: UM Sylvester Comprehensive Cancer Center at Coral Gables
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facility: UM Sylvester Comprehensive Cancer Center at Deerfield Beach
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facility: UM Sylvester Comprehensive Cancer Center at Doral
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city: Fort Myers
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facility: GenesisCare USA - FGO
state: Florida
city: Fort Myers
country: United States
facility: Regional Cancer Center-Lee Memorial Health System
state: Florida
city: Gainesville
country: United States
facility: University of Florida Health Science Center - Gainesville
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city: Miami
country: United States
facility: Jackson Memorial Hospital-Holtz Children's Hospital
state: Florida
city: Miami
country: United States
facility: University of Miami Miller School of Medicine-Sylvester Cancer Center
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facility: UM Sylvester Comprehensive Cancer Center at Kendall
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city: N. Venice
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facility: Sarasota Memorial Hospital-Venice
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facility: UM Sylvester Comprehensive Cancer Center at Plantation
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city: Sarasota
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city: Sarasota
country: United States
facility: Intercoastal Medical Group - Cattleridge II
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city: Sarasota
country: United States
facility: Florida Cancer Specialists - Sarasota Downtown
state: Florida
city: Sarasota
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facility: First Physicians Group - Urology Robotic and Minimally Invasive Surgery
state: Florida
city: Sarasota
country: United States
facility: First Physicians Group-Sarasota
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
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city: Venice
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facility: Florida Cancer Specialists - Venice Pinebrook
state: Florida
city: Venice
country: United States
facility: Florida Cancer Specialists - Venice Island
state: Florida
city: Atlanta
country: United States
facility: Grady Health System
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital/Winship Cancer Institute
state: Georgia
city: Atlanta
country: United States
facility: Emory Saint Joseph's Hospital
state: Georgia
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
city: Augusta
country: United States
facility: Augusta University Medical Center
state: Georgia
city: Newnan
country: United States
facility: CTCA at Southeastern Regional Medical Center
state: Georgia
city: Savannah
country: United States
facility: Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
state: Georgia
city: 'Aiea
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facility: Hawaii Cancer Care - Westridge
state: Hawaii
city: 'Aiea
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facility: Pali Momi Medical Center
state: Hawaii
city: 'Aiea
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facility: Queen's Cancer Center - Pearlridge
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city: 'Aiea
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facility: The Cancer Center of Hawaii-Pali Momi
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city: 'Ewa Beach
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facility: The Queen's Medical Center - West Oahu
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city: Honolulu
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city: Honolulu
country: United States
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state: Hawaii
city: Honolulu
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facility: University of Hawaii Cancer Center
state: Hawaii
city: Honolulu
country: United States
facility: Hawaii Cancer Care Inc-Liliha
state: Hawaii
city: Honolulu
country: United States
facility: Kuakini Medical Center
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: Honolulu
country: United States
facility: Kaiser Permanente Moanalua Medical Center
state: Hawaii
city: Honolulu
country: United States
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state: Hawaii
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state: Hawaii
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country: United States
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city: Meridian
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facility: Rush - Copley Medical Center
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city: Aurora
country: United States
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city: New Lenox
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city: Normal
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state: Illinois
city: Normal
country: United States
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city: Oak Lawn
country: United States
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city: Oak Park
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city: Orland Park
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city: Park Ridge
country: United States
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state: Illinois
city: Plainfield
country: United States
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state: Illinois
city: Springfield
country: United States
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state: Illinois
city: Urbana
country: United States
facility: Carle Cancer Center
state: Illinois
city: Urbana
country: United States
facility: The Carle Foundation Hospital
state: Illinois
city: Warrenville
country: United States
facility: Northwestern Medicine Cancer Center Warrenville
state: Illinois
city: Yorkville
country: United States
facility: Rush-Copley Healthcare Center
state: Illinois
city: Zion
country: United States
facility: Midwestern Regional Medical Center
state: Illinois
city: Carmel
country: United States
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state: Indiana
city: Crown Point
country: United States
facility: UChicago Medicine Northwest Indiana
state: Indiana
city: Goshen
country: United States
facility: Goshen Center for Cancer Care
state: Indiana
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 North
state: Indiana
city: Indianapolis
country: United States
facility: Ascension Saint Vincent Indianapolis Hospital
state: Indiana
city: New Albany
country: United States
facility: Baptist Health Floyd
state: Indiana
city: Council Bluffs
country: United States
facility: Heartland Oncology and Hematology LLP
state: Iowa
city: Council Bluffs
country: United States
facility: Methodist Jennie Edmundson Hospital
state: Iowa
city: Council Bluffs
country: United States
facility: Nebraska Cancer Specialists/Oncology Hematology West PC - MEJ
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa/Holden Comprehensive Cancer Center
state: Iowa
city: Fairway
country: United States
facility: University of Kansas Clinical Research Center
state: Kansas
city: Kansas City
country: United States
facility: University of Kansas Cancer Center
state: Kansas
city: Overland Park
country: United States
facility: University of Kansas Hospital-Indian Creek Campus
state: Kansas
city: Westwood
country: United States
facility: University of Kansas Hospital-Westwood Cancer Center
state: Kansas
city: Corbin
country: United States
facility: Baptist Health Corbin
state: Kentucky
city: Edgewood
country: United States
facility: Saint Elizabeth Healthcare Edgewood
state: Kentucky
city: Elizabethtown
country: United States
facility: Baptist Health Hardin
state: Kentucky
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Louisville
country: United States
facility: Norton Hospital Pavilion and Medical Campus
state: Kentucky
city: Louisville
country: United States
facility: Baptist Health Louisville
state: Kentucky
city: Louisville
country: United States
facility: Norton Suburban Hospital and Medical Campus
state: Kentucky
city: Madisonville
country: United States
facility: Baptist Health Madisonville/Merle Mahr Cancer Center
state: Kentucky
city: Paducah
country: United States
facility: Baptist Health Paducah
state: Kentucky
city: Richmond
country: United States
facility: Baptist Health Richmond
state: Kentucky
city: Marrero
country: United States
facility: West Jefferson Medical Center
state: Louisiana
city: New Orleans
country: United States
facility: Louisiana State University Health Science Center
state: Louisiana
city: New Orleans
country: United States
facility: University Medical Center New Orleans
state: Louisiana
city: Shreveport
country: United States
facility: Willis-Knighton Medical and Cancer Center
state: Louisiana
city: Portland
country: United States
facility: MaineHealth Maine Medical Center - Portland
state: Maine
city: Scarborough
country: United States
facility: MaineHealth Maine Medical Center- Scarborough
state: Maine
city: Baltimore
country: United States
facility: University of Maryland/Greenebaum Cancer Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University/Sidney Kimmel Cancer Center
state: Maryland
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: Elkton
country: United States
facility: Christiana Care - Union Hospital
state: Maryland
city: Glen Burnie
country: United States
facility: UM Baltimore Washington Medical Center/Tate Cancer Center
state: Maryland
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Dearborn
country: United States
facility: Corewell Health Dearborn Hospital
state: Michigan
city: Detroit
country: United States
facility: Wayne State University/Karmanos Cancer Institute
state: Michigan
city: Farmington Hills
country: United States
facility: Weisberg Cancer Treatment Center
state: Michigan
city: Farmington Hills
country: United States
facility: Corewell Health Farmington Hills Hospital
state: Michigan
city: Flint
country: United States
facility: McLaren Cancer Institute-Flint
state: Michigan
city: Grand Rapids
country: United States
facility: Corewell Health Grand Rapids Hospitals - Butterworth Hospital
state: Michigan
city: Kalamazoo
country: United States
facility: Bronson Methodist Hospital
state: Michigan
city: Kalamazoo
country: United States
facility: West Michigan Cancer Center
state: Michigan
city: Kalamazoo
country: United States
facility: Ascension Borgess Hospital
state: Michigan
city: Muskegon
country: United States
facility: Trinity Health Muskegon Hospital
state: Michigan
city: Royal Oak
country: United States
facility: Oakland Colon Rectal Associates
state: Michigan
city: Royal Oak
country: United States
facility: Cancer Care Associates PC
state: Michigan
city: Royal Oak
country: United States
facility: Comprehensive Medical Center PLLC
state: Michigan
city: Royal Oak
country: United States
facility: Corewell Health William Beaumont University Hospital
state: Michigan
city: Royal Oak
country: United States
facility: Hematology Oncology Consultants PC-Royal Oak
state: Michigan
city: Royal Oak
country: United States
facility: Oakland Medical Group
state: Michigan
city: Sterling Heights
country: United States
facility: Premier Hematology Oncology Care
state: Michigan
city: Troy
country: United States
facility: Michigan Institute of Urology-Town Center
state: Michigan
city: Troy
country: United States
facility: Corewell Health Beaumont Troy Hospital
state: Michigan
city: Troy
country: United States
facility: Hematology Oncology Consultants PC-Troy
state: Michigan
city: Burnsville
country: United States
facility: Minnesota Oncology - Burnsville
state: Minnesota
city: Cambridge
country: United States
facility: Cambridge Medical Center
state: Minnesota
city: Coon Rapids
country: United States
facility: Mercy Hospital
state: Minnesota
city: Edina
country: United States
facility: Fairview Southdale Hospital
state: Minnesota
city: Fridley
country: United States
facility: Unity Hospital
state: Minnesota
city: Maple Grove
country: United States
facility: Fairview Clinics and Surgery Center Maple Grove
state: Minnesota
city: Maplewood
country: United States
facility: Minnesota Oncology Hematology PA-Maplewood
state: Minnesota
city: Maplewood
country: United States
facility: Saint John's Hospital - Healtheast
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: Minneapolis
country: United States
facility: Health Partners Inc
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota/Masonic Cancer Center
state: Minnesota
city: Monticello
country: United States
facility: Monticello Cancer Center
state: Minnesota
city: New Ulm
country: United States
facility: New Ulm Medical Center
state: Minnesota
city: Princeton
country: United States
facility: Fairview Northland Medical Center
state: Minnesota
city: Robbinsdale
country: United States
facility: North Memorial Medical Health Center
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
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: Saint Paul
country: United States
facility: United Hospital
state: Minnesota
city: Shakopee
country: United States
facility: Saint Francis Regional Medical Center
state: Minnesota
city: Stillwater
country: United States
facility: Lakeview Hospital
state: Minnesota
city: Waconia
country: United States
facility: Ridgeview Medical Center
state: Minnesota
city: Willmar
country: United States
facility: Rice Memorial Hospital
state: Minnesota
city: Woodbury
country: United States
facility: Minnesota Oncology Hematology PA-Woodbury
state: Minnesota
city: Wyoming
country: United States
facility: Fairview Lakes Medical Center
state: Minnesota
city: North Kansas City
country: United States
facility: University of Kansas Cancer Center at North Kansas City Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Hospital South
state: Missouri
city: Saint Louis
country: United States
facility: Missouri Baptist Medical Center
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Hospital Saint Louis
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: Billings
country: United States
facility: Billings Clinic Cancer Center
state: Montana
city: Bozeman
country: United States
facility: Bozeman Health Deaconess Hospital
state: Montana
city: Missoula
country: United States
facility: Saint Patrick Hospital - Community Hospital
state: Montana
city: Missoula
country: United States
facility: Community Medical Center
state: Montana
city: Omaha
country: United States
facility: Nebraska Cancer Specialists/Oncology Hematology West PC - MECC
state: Nebraska
city: Omaha
country: United States
facility: Nebraska Methodist Hospital
state: Nebraska
city: Omaha
country: United States
facility: Oncology Associates PC
state: Nebraska
city: Omaha
country: United States
facility: Nebraska Medicine-Village Pointe
state: Nebraska
city: Omaha
country: United States
facility: Alegent Health Bergan Mercy Medical Center
state: Nebraska
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Las Vegas
country: United States
facility: Women's Cancer Center of Nevada
state: Nevada
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: Jersey City
country: United States
facility: Jersey City Medical Center
state: New Jersey
city: Livingston
country: United States
facility: Saint Barnabas 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: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: Mount Holly
country: United States
facility: Virtua Memorial
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Newark
country: United States
facility: Rutgers New Jersey Medical School
state: New Jersey
city: Pennington
country: United States
facility: Capital Health Medical Center-Hopewell
state: New Jersey
city: Plainsboro
country: United States
facility: Penn Medicine Princeton Health
state: New Jersey
city: Somerville
country: United States
facility: Robert Wood Johnson University Hospital Somerset
state: New Jersey
city: Summit
country: United States
facility: Overlook Hospital
state: New Jersey
city: Voorhees
country: United States
facility: Virtua Voorhees
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Center
state: New Mexico
city: Albuquerque
country: United States
facility: Presbyterian Kaseman Hospital
state: New Mexico
city: Rio Rancho
country: United States
facility: Presbyterian Rust Medical Center/Jorgensen Cancer Center
state: New Mexico
city: Albany
country: United States
facility: Women's Cancer Care Associates LLC
state: New York
city: Bay Shore
country: United States
facility: Northwell Health Imbert Cancer Center
state: New York
city: Bay Shore
country: United States
facility: South Shore University Hospital
state: New York
city: Brightwaters
country: United States
facility: Island Gynecologic Oncology
state: New York
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack
state: New York
city: Flushing
country: United States
facility: Northwell Health Physician Partners at Flushing
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: Huntington
country: United States
facility: Huntington Hospital
state: New York
city: Lake Success
country: United States
facility: Northwell Health/Center for Advanced Medicine
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: Mineola
country: United States
facility: NYU Langone Hospital - Long Island
state: New York
city: Mount Kisco
country: United States
facility: Northern Westchester Hospital
state: New York
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: New Hyde Park
country: United States
facility: Northwell Health Physician Partners
state: New York
city: New York
country: United States
facility: Mount Sinai Chelsea
state: New York
city: New York
country: United States
facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone
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: NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
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: NYP/Weill Cornell Medical Center
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Poughkeepsie
country: United States
facility: Vassar Brothers Medical Center
state: New York
city: Rego Park
country: United States
facility: Northwell Physician Partners at Rego Park
state: New York
city: Rego Park
country: United States
facility: Queens Cancer Center
state: New York
city: Rochester
country: United States
facility: Highland Hospital
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Sleepy Hollow
country: United States
facility: Phelps Memorial Hospital Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
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: Cary
country: United States
facility: Duke Cancer Center Cary
state: North Carolina
city: Chapel Hill
country: United States
facility: UNC Lineberger Comprehensive Cancer Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Raleigh
country: United States
facility: Duke Women's Cancer Care Raleigh
state: North Carolina
city: Raleigh
country: United States
facility: Duke Cancer Center Raleigh
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Akron
country: United States
facility: Cleveland Clinic Akron General
state: Ohio
city: Alliance
country: United States
facility: Aultman Alliance Community Hospital
state: Ohio
city: Athens
country: United States
facility: OhioHealth O'Bleness Hospital
state: Ohio
city: Canton
country: United States
facility: Aultman Health Foundation
state: Ohio
city: Centerville
country: United States
facility: Miami Valley Hospital South
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati Cancer Center-UC Medical Center
state: Ohio
city: Cincinnati
country: United States
facility: Good Samaritan Hospital - Cincinnati
state: Ohio
city: Cincinnati
country: United States
facility: Bethesda North Hospital
state: Ohio
city: Cincinnati
country: United States
facility: TriHealth Cancer Institute-Westside
state: Ohio
city: Cincinnati
country: United States
facility: TriHealth Cancer Institute-Anderson
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Cancer Center/Fairview Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
city: Columbus
country: United States
facility: Columbus Oncology and Hematology Associates Inc
state: Ohio
city: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
city: Columbus
country: United States
facility: Grant Medical Center
state: Ohio
city: Columbus
country: United States
facility: Doctors Hospital
state: Ohio
city: Dayton
country: United States
facility: Miami Valley Hospital
state: Ohio
city: Dayton
country: United States
facility: Miami Valley Hospital North
state: Ohio
city: Delaware
country: United States
facility: Delaware Health Center-Grady Cancer Center
state: Ohio
city: Delaware
country: United States
facility: Grady Memorial Hospital
state: Ohio
city: Dublin
country: United States
facility: Columbus Oncology and Hematology Associates
state: Ohio
city: Dublin
country: United States
facility: Dublin Methodist Hospital
state: Ohio
city: Franklin
country: United States
facility: Atrium Medical Center-Middletown Regional Hospital
state: Ohio
city: Greenville
country: United States
facility: Miami Valley Cancer Care and Infusion
state: Ohio
city: Mansfield
country: United States
facility: OhioHealth Mansfield Hospital
state: Ohio
city: Marion
country: United States
facility: OhioHealth Marion General Hospital
state: Ohio
city: Mayfield Heights
country: United States
facility: Hillcrest Hospital Cancer Center
state: Ohio
city: Pickerington
country: United States
facility: OhioHealth Pickerington Methodist Hospital
state: Ohio
city: Sylvania
country: United States
facility: ProMedica Flower Hospital
state: Ohio
city: Toledo
country: United States
facility: ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
state: Ohio
city: Troy
country: United States
facility: Upper Valley Medical Center
state: Ohio
city: West Chester
country: United States
facility: University of Cincinnati Cancer Center-West Chester
state: Ohio
city: Westerville
country: United States
facility: OhioHealth Westerville Medical Campus/Westerville Cancer Center
state: Ohio
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: Bend
country: United States
facility: Saint Charles Health System
state: Oregon
city: Clackamas
country: United States
facility: Clackamas Radiation Oncology Center
state: Oregon
city: Clackamas
country: United States
facility: Providence Cancer Institute Clackamas Clinic
state: Oregon
city: Coos Bay
country: United States
facility: Bay Area Hospital
state: Oregon
city: Newberg
country: United States
facility: Providence Newberg Medical Center
state: Oregon
city: Oregon City
country: United States
facility: Providence Willamette Falls 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: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Redmond
country: United States
facility: Saint Charles Health System-Redmond
state: Oregon
city: Tualatin
country: United States
facility: Legacy Meridian Park Hospital
state: Oregon
city: Abington
country: United States
facility: Jefferson Abington Hospital
state: Pennsylvania
city: Chadds Ford
country: United States
facility: Christiana Care Health System-Concord Health Center
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Milton S Hershey Medical Center
state: Pennsylvania
city: Jefferson Hills
country: United States
facility: Jefferson Hospital
state: Pennsylvania
city: Lancaster
country: United States
facility: Lancaster General Ann B Barshinger Cancer Institute
state: Pennsylvania
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Monroeville
country: United States
facility: Forbes Hospital
state: Pennsylvania
city: Natrona Heights
country: United States
facility: Allegheny Valley Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania/Abramson Cancer Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC-Magee Womens Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: West Penn Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Cancer Institute (UPCI)
state: Pennsylvania
city: West Chester
country: United States
facility: Chester County Hospital
state: Pennsylvania
city: Wexford
country: United States
facility: Wexford Health and Wellness Pavilion
state: Pennsylvania
city: Willow Grove
country: United States
facility: Asplundh Cancer Pavilion
state: Pennsylvania
city: Providence
country: United States
facility: Women and Infants Hospital
state: Rhode Island
city: Bluffton
country: United States
facility: Saint Joseph's/Candler - Bluffton Campus
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Gaffney
country: United States
facility: Gibbs Cancer Center-Gaffney
state: South Carolina
city: Greenville
country: United States
facility: Prisma Health Cancer Institute - Faris
state: South Carolina
city: Greenville
country: United States
facility: Prisma Health Greenville Memorial Hospital
state: South Carolina
city: Greer
country: United States
facility: Gibbs Cancer Center-Pelham
state: South Carolina
city: Seneca
country: United States
facility: Prisma Health Cancer Institute - Seneca
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Center
state: South Carolina
city: Union
country: United States
facility: SMC Center for Hematology Oncology Union
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: Franklin
country: United States
facility: Vanderbilt-Ingram Cancer Center at Franklin
state: Tennessee
city: Franklin
country: United States
facility: Vanderbilt-Ingram Cancer Center Cool Springs
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Breast Center at One Hundred Oaks
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University/Ingram Cancer Center
state: Tennessee
city: Dallas
country: United States
facility: Parkland Memorial Hospital
state: Texas
city: Dallas
country: United States
facility: UT Southwestern/Simmons Cancer Center-Dallas
state: Texas
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
state: Texas
city: Houston
country: United States
facility: Ben Taub General Hospital
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Texas Medical Center
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Sugarhouse Health Center
state: Utah
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute/University of Utah
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Cancer Center
state: Virginia
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute
state: Virginia
city: Fairfax
country: United States
facility: Inova Fair Oaks Hospital
state: Virginia
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Richmond
country: United States
facility: Henrico Doctor's Hospital
state: Virginia
city: Richmond
country: United States
facility: VCU Massey Cancer Center at Stony Point
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University/Massey Cancer Center
state: Virginia
city: Roanoke
country: United States
facility: Carilion Roanoke Memorial Hospital
state: Virginia
city: Aberdeen
country: United States
facility: Providence Regional Cancer System-Aberdeen
state: Washington
city: Bellingham
country: United States
facility: PeaceHealth Saint Joseph Medical Center
state: Washington
city: Centralia
country: United States
facility: Providence Regional Cancer System-Centralia
state: Washington
city: Edmonds
country: United States
facility: Swedish Cancer Institute-Edmonds
state: Washington
city: Everett
country: United States
facility: Providence Regional Cancer Partnership
state: Washington
city: Issaquah
country: United States
facility: Swedish Cancer Institute-Issaquah
state: Washington
city: Kennewick
country: United States
facility: Kadlec Clinic Hematology and Oncology
state: Washington
city: Lacey
country: United States
facility: Providence Regional Cancer System-Lacey
state: Washington
city: Longview
country: United States
facility: PeaceHealth Saint John Medical Center
state: Washington
city: Mount Vernon
country: United States
facility: Skagit Regional Health Cancer Care Center
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center-Ballard Campus
state: Washington
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center-Cherry Hill
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center-First Hill
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center - Northwest
state: Washington
city: Seattle
country: United States
facility: Women's Cancer Center of Seattle
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center - Montlake
state: Washington
city: Sedro-Woolley
country: United States
facility: PeaceHealth United General Medical Center
state: Washington
city: Shelton
country: United States
facility: Providence Regional Cancer System-Shelton
state: Washington
city: Vancouver
country: United States
facility: Legacy Salmon Creek Hospital
state: Washington
city: Walla Walla
country: United States
facility: Providence Saint Mary Regional Cancer Center
state: Washington
city: Yelm
country: United States
facility: Providence Regional Cancer System-Yelm
state: Washington
city: Bridgeport
country: United States
facility: United Hospital Center
state: West Virginia
city: Charleston
country: United States
facility: West Virginia University Charleston Division
state: West Virginia
city: Martinsburg
country: United States
facility: WVUH-Berkely Medical Center
state: West Virginia
city: Morgantown
country: United States
facility: West Virginia University Healthcare
state: West Virginia
city: Parkersburg
country: United States
facility: Camden Clark Medical Center
state: West Virginia
city: Princeton
country: United States
facility: Princeton Community Hospital
state: West Virginia
city: Wheeling
country: United States
facility: Wheeling Hospital/Schiffler Cancer Center
state: West Virginia
city: Burlington
country: United States
facility: Aurora Cancer Care-Southern Lakes VLCC
state: Wisconsin
city: Cudahy
country: United States
facility: Aurora Saint Luke's South Shore
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: Saint Vincent Hospital Cancer Center Green Bay
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: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center - Eastpark 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: Milwaukee
country: United States
facility: Aurora Cancer Care-Milwaukee
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora Saint Luke's Medical Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora Sinai Medical Center
state: Wisconsin
city: Mukwonago
country: United States
facility: ProHealth D N Greenwald Center
state: Wisconsin
city: New Richmond
country: United States
facility: Cancer Center of Western Wisconsin
state: Wisconsin
city: Oconomowoc
country: United States
facility: ProHealth Oconomowoc Memorial Hospital
state: Wisconsin
city: Oshkosh
country: United States
facility: Vince Lombardi Cancer Clinic - Oshkosh
state: Wisconsin
city: Racine
country: United States
facility: Aurora Cancer Care-Racine
state: Wisconsin
city: Sheboygan
country: United States
facility: Vince Lombardi Cancer Clinic-Sheboygan
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: ProHealth Waukesha Memorial Hospital
state: Wisconsin
city: Waukesha
country: United States
facility: UW Cancer Center at ProHealth Care
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: Vancouver
country: Canada
facility: BCCA-Vancouver Cancer Centre
state: British Columbia
city: Dalseo-gu
country: Korea, Republic of
facility: Keimyung University-Dongsan Medical Center
state: Daegu
city: Seoul
country: Korea, Republic of
facility: Samsung Changwon Hospital
state: Gyeongsangnam-do
city: Seongnam City
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Kyeonggi-do
city: Gwangmyeong-si
country: Korea, Republic of
facility: Chung-Ang University Gwangmyeong Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System-Severance Hospital
Study officials:
affiliation: NRG Oncology
name: Kathryn P Pennington
role: PRINCIPAL_INVESTIGATOR
References: