Clinical trial NCT02893930: Sapanisertib in Treating Patients With Metastatic or Refractory Pancreatic Neuroendocrine Tumor That Cannot Be Removed by Surgery
Official title: A Phase II Study of MLN0128 (TAK-228) in Rapalog-Resistant Advanced Pancreatic Neuroendocrine Tumors (PNET)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Neuroendocrine Tumor G1
Pancreatic Neuroendocrine Tumor G2
Refractory Pancreatic Neuroendocrine Carcinoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2016-09-09
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This phase II trial studies how well sapanisertib works in treating patients with pancreatic neuroendocrine tumor that has spread to other places in the body (metastatic), does not respond to treatment (refractory), or cannot be surgically removed. Drugs such as sapanisertib may stop the growth or shrink tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description: PRIMARY OBJECTIVE:

I. To evaluate overall response rate associated with sapanisertib (MLN0128 \[TAK-228\]) in patients with advanced pancreatic neuroendocrine tumors (PNETs).

SECONDARY ENDPOINTS:

I. To evaluate progression-free survival (PFS) associated with MLN0128 (TAK-228) in patients with advanced pancreatic neuroendocrine tumors (PNETs).

II. To measure the safety and tolerability of MLN0128 (TAK-228) in patients with advanced PNETs.

III. To evaluate disease control rate associated with MLN0128 (TAK-228) in patients with advanced PNETs.

IV. To measure duration of response rate associated with MLN0128 (TAK-228) in patients with advanced PNETs.

OUTLINE:

Patients receive sapanisertib orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 1 year, and then yearly for 2 years.

Eligibility criteria: Inclusion Criteria:

* Patients must have unresectable or metastatic, histologically confirmed low or intermediate grade (Klimstra Criteria) pancreatic neuroendocrine tumor (PNET) with radiological evidence of disease progression since last treatment
* Refractory disease to treatment with an mTOR inhibitor
* Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, are ineligible
* Disease that is currently not amenable to surgery, radiation, or combined modality therapy with curative intent
* Patients must not have poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid and small cell carcinoma
* Patients must have measurable disease
* Documented radiological evidence for disease progression (measurable or nonmeasurable) =\< 12 months prior to enrollment

  * NOTE: If patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation; at least one measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST)
* Prior or concurrent therapy with somatostatin analogue (SSA) is permitted; a stable dose at least 2 months prior to study start and must continue on the stable dose while receiving study treatment; SSA is not considered as systemic treatment
* Recovered from adverse events to grade 1 or less toxicity according to Common Terminology Criteria for Adverse Events version 4.0 (CTCAE 4.0) due to agents administered previously

  * NOTE: Chemotherapy-induced alopecia and grade 2 neuropathy are acceptable
* Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Patients must be able to swallow intact capsules
* Leukocytes \>= 3,000/mm\^3 (within less than or equal to 14 days prior to registration)
* Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L (within less than or equal to 14 days prior to registration)
* Hemoglobin \>= 10 g/dL (within less than or equal to 14 days prior to registration)
* Platelets \>= 100 x 10\^9/L (within less than or equal to 14 days prior to registration)
* Total serum bilirubin =\< institutional upper limit of normal (ULN) (within less than or equal to 14 days prior to registration)
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 2.5 x ULN (within less than or equal to 14 days prior to registration)
* Serum creatinine =\< 1.5 X institutional ULN and creatinine clearance \>= 60 ml/min (within less than or equal to 14 days prior to registration)

  * NOTE: Creatinine clearance must be calculated using the Cockcroft-Gault equation
* Glycosylated hemoglobin (HbA1c) \< 7.0% (within less than or equal to 14 days prior to registration)
* Fasting serum glucose =\< 130 mg/dL (within less than or equal to 14 days prior to registration)
* Fasting triglycerides =\< 300 mg/dL (within less than or equal to 14 days prior to registration)
* Diabetics are allowed if:

  * Fasting blood glucose (FBG) =\< 130 mg/dL (mmol/L), OR
  * HbA1c =\< 7%
* Women must not be pregnant or breast-feeding due to potential harm to the fetus from MLN0128 (TAK-228); all females of childbearing potential must have a blood test or urine study within 7 days of registration to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
* Women of child-bearing potential and men must agree to practice 1 highly effective method of contraception and 1 additional effective (barrier) method of contraception, at the same time, from the time of signing the informed consent through 90 days (for female patients) and 120 day (for male patients) after the last dose of study drug, or agree to completely abstain from heterosexual intercourse; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men must agree not to donate sperm during the course of this study or within 120 days after receiving their last dose of study drug
* Patients who have a history of brain metastasis are eligible for the study provided that all the following criteria are met:

  * Brain metastases which have been treated
  * No evidence of disease progression for \>= 3 months before the first dose of study drug
  * No hemorrhage after treatment
  * Off-treatment with dexamethasone for 4 weeks before administration of the first dose of TAK-228
  * No ongoing requirement for dexamethasone or anti-epileptic drugs
* Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care

Exclusion Criteria:

* Patient is INELIGIBLE if patient discontinued prior mTOR inhibitor due to toxicity
* Patients must NOT have radiotherapy, or major surgery or active drug therapy for pNET (SSA permitted) within 4 weeks prior to study treatment start
* Patient must NOT have had previous treatment with any PI3K or AKT inhibitor
* NO hepatic artery embolization or cryoablation/radiofrequency ablation of hepatic metastasis within 2 months of study treatment start
* Patients must NOT have previous or concurrent malignancy within 2 years; exceptions are made for patients who meet any of the following conditions:

  * Adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer OR
  * Adequately treated stage I or II cancer currently in complete remission, or any other cancer that has been in complete remission for at least 2 years
* No more than 3 prior systemic treatment regimens for advanced PNET
* Patients with a history of the following within =\< 6 months of study entry are NOT eligible:

  * Ischemic myocardial event, including angina requiring therapy and artery revascularization procedures
  * Ischemic cerebrovascular event, including transient ischemic attack (TIA) and artery revascularization procedures
  * Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation or ventricular tachycardia)
  * New York Heart Association (NYHA) class III or IV heart failure
  * Pulmonary embolism
* Patients with known significant active cardiovascular or pulmonary disease at the time of study entry are INELIGIBLE including:

  * Uncontrolled hypertension (i.e., systolic blood pressure \>180 mm Hg, diastolic blood pressure \> 95 mm Hg); use of anti-hypertensive agents to control hypertension before cycle1 day 1 is allowed
  * Pulmonary hypertension
  * Uncontrolled asthma or oxygen (O2) saturation \< 90% by arterial blood gas analysis or pulse oximetry on room air
  * QT syndrome, or torsades de pointes
  * Significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention, or history of valve replacement
  * Medically significant (symptomatic) bradycardia
  * History of arrhythmia requiring an implantable cardiac defibrillator
  * Baseline prolongation of the rate-corrected QT interval (QTc) (e.g., repeated demonstration of QTc interval \> 480 milliseconds, or history of congenital long
* Patients with known manifestations of malabsorption due to prior gastrointestinal (GI) surgery, GI disease, or for an unknown reason that may alter the absorption of MLN0128 (TAK-228) are INELIGIBLE
* Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are INELGIBLE because of the potential for pharmacokinetic interactions with MLN0128 (TAK-228)
* NO treatment with strong inhibitors and/or inducers of cytochrome P450 (CYP) 3A4, or CYP2C19 within 1 week preceding the first dose of study drug
* NO patients receiving systemic corticosteroids (either intravenous \[IV\] or oral steroids, excluding inhalers or low-dose hormone replacement therapy) within 1 week before administration of the first dose of study drug
* Patients CANNOT have daily or chronic use of a proton pump inhibitor (PPI) and/or having taken a PPI within 7 days before receiving the first dose of study drug

Primary outcomes:
measure: Overall Response Rate
timeFrame: Assessed every 3 months for the first 2 years, every 6 months for the 3rd year, then annually up to 5 years
Secondary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: Assessed every 3 months for 2 years, every 6 months for the 3rd year, then annually up to 5 years
measure: Disease Control Rate
timeFrame: Assessed every 3 months for 2 years, every 6 months for the 3rd year, then annually up to 5 years
measure: Duration of Response
timeFrame: Assessed every 3 months for 2 years, every 6 months for the 3rd year, then annually up to 5 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Hospital in Arizona
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Hot Springs
country: United States
facility: CHI Saint Vincent Cancer Center Hot Springs
state: Arkansas
city: Arroyo Grande
country: United States
facility: PCR Oncology
state: California
city: Auburn
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facility: Sutter Auburn Faith Hospital
state: California
city: Auburn
country: United States
facility: Sutter Cancer Centers Radiation Oncology Services-Auburn
state: California
city: Berkeley
country: United States
facility: Alta Bates Summit Medical Center-Herrick Campus
state: California
city: Burlingame
country: United States
facility: Mills-Peninsula Medical Center
state: California
city: Cameron Park
country: United States
facility: Sutter Cancer Centers Radiation Oncology Services-Cameron Park
state: California
city: Castro Valley
country: United States
facility: Eden Hospital Medical Center
state: California
city: Davis
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facility: Sutter Davis Hospital
state: California
city: Fremont
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facility: Palo Alto Medical Foundation-Fremont
state: California
city: Los Angeles
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facility: Cedars Sinai Medical Center
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city: Modesto
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facility: Memorial Medical Center
state: California
city: Mountain View
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facility: Palo Alto Medical Foundation-Camino Division
state: California
city: Mountain View
country: United States
facility: Palo Alto Medical Foundation-Gynecologic Oncology
state: California
city: Novato
country: United States
facility: Sutter Cancer Research Consortium
state: California
city: Palo Alto
country: United States
facility: Palo Alto Medical Foundation Health Care
state: California
city: Palo Alto
country: United States
facility: Stanford Cancer Institute Palo Alto
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: Sacramento
country: United States
facility: Sutter Medical Center Sacramento
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center-Pacific Campus
state: California
city: Santa Cruz
country: United States
facility: Palo Alto Medical Foundation-Santa Cruz
state: California
city: Santa Rosa
country: United States
facility: Sutter Pacific Medical Foundation
state: California
city: Sunnyvale
country: United States
facility: Palo Alto Medical Foundation-Sunnyvale
state: California
city: Vacaville
country: United States
facility: Sutter Cancer Centers Radiation Oncology Services-Vacaville
state: California
city: Vallejo
country: United States
facility: Sutter Solano Medical Center/Cancer Center
state: California
city: Aurora
country: United States
facility: 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: Rocky Mountain Cancer Centers-Penrose
state: Colorado
city: Colorado Springs
country: United States
facility: UCHealth Memorial Hospital Central
state: Colorado
city: Denver
country: United States
facility: Porter Adventist Hospital
state: Colorado
city: Durango
country: United States
facility: Mercy Medical Center
state: Colorado
city: Durango
country: United States
facility: Southwest Oncology PC
state: Colorado
city: Fort Collins
country: United States
facility: Poudre Valley Hospital
state: Colorado
city: Golden
country: United States
facility: Mountain Blue Cancer Care Center
state: Colorado
city: Lakewood
country: United States
facility: Rocky Mountain Cancer Centers-Lakewood
state: Colorado
city: Lakewood
country: United States
facility: Saint Anthony Hospital
state: Colorado
city: Littleton
country: United States
facility: Littleton Adventist Hospital
state: Colorado
city: Longmont
country: United States
facility: Longmont United Hospital
state: Colorado
city: Longmont
country: United States
facility: Rocky Mountain Cancer Centers-Longmont
state: Colorado
city: Parker
country: United States
facility: Parker Adventist Hospital
state: Colorado
city: Parker
country: United States
facility: Rocky Mountain Cancer Centers-Parker
state: Colorado
city: Pueblo
country: United States
facility: Saint Mary Corwin Medical Center
state: Colorado
city: Pueblo
country: United States
facility: Rocky Mountain Cancer Centers - Pueblo
state: Colorado
city: Thornton
country: United States
facility: Rocky Mountain Cancer Centers-Thornton
state: Colorado
city: Middletown
country: United States
facility: Middlesex Hospital
state: Connecticut
city: 'Aiea
country: United States
facility: Pali Momi Medical Center
state: Hawaii
city: 'Aiea
country: United States
facility: Queen's Cancer Center - Pearlridge
state: Hawaii
city: 'Aiea
country: United States
facility: The Cancer Center of Hawaii-Pali Momi
state: Hawaii
city: Honolulu
country: United States
facility: Hawaii Cancer Care Inc - Waterfront Plaza
state: Hawaii
city: Honolulu
country: United States
facility: Island Urology
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: 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: Kapiolani Medical Center for Women and Children
state: Hawaii
city: Lihue
country: United States
facility: Wilcox Memorial Hospital and Kauai Medical Clinic
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: Coeur d'Alene
country: United States
facility: Kootenai Health - Coeur d'Alene
state: Idaho
city: Emmett
country: United States
facility: Walter Knox Memorial Hospital
state: Idaho
city: Meridian
country: United States
facility: Idaho Urologic Institute-Meridian
state: Idaho
city: Nampa
country: United States
facility: Saint Alphonsus Medical Center-Nampa
state: Idaho
city: Post Falls
country: United States
facility: Kootenai Clinic Cancer Services - Post Falls
state: Idaho
city: Sandpoint
country: United States
facility: Kootenai Cancer Clinic
state: Idaho
city: Aurora
country: United States
facility: Rush - Copley Medical Center
state: Illinois
city: Bloomington
country: United States
facility: 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: Carbondale
country: United States
facility: Memorial Hospital of Carbondale
state: Illinois
city: Carterville
country: United States
facility: SIH Cancer Institute
state: Illinois
city: Carthage
country: United States
facility: Illinois CancerCare-Carthage
state: Illinois
city: Centralia
country: United States
facility: Centralia Oncology Clinic
state: Illinois
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Danville
country: United States
facility: Carle on Vermilion
state: Illinois
city: Decatur
country: United States
facility: Cancer Care Specialists of Illinois - Decatur
state: Illinois
city: Decatur
country: United States
facility: Decatur Memorial Hospital
state: Illinois
city: Effingham
country: United States
facility: Carle Physician Group-Effingham
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: Geneva
country: United States
facility: Northwestern Medicine Cancer Center Delnor
state: Illinois
city: Kewanee
country: United States
facility: Illinois CancerCare-Kewanee Clinic
state: Illinois
city: Lake Forest
country: United States
facility: Northwestern Medicine Lake Forest Hospital
state: Illinois
city: Macomb
country: United States
facility: Illinois CancerCare-Macomb
state: Illinois
city: Mattoon
country: United States
facility: Carle Physician Group-Mattoon/Charleston
state: Illinois
city: Mount Vernon
country: United States
facility: Good Samaritan Regional Health Center
state: Illinois
city: O'Fallon
country: United States
facility: Cancer Care Center of O'Fallon
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: Pekin
country: United States
facility: OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
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: Peru
country: United States
facility: Valley Radiation Oncology
state: Illinois
city: Princeton
country: United States
facility: Illinois CancerCare-Princeton
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: Memorial Medical Center
state: Illinois
city: Swansea
country: United States
facility: Southwest Illinois Health Services LLP
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: Evansville
country: United States
facility: Deaconess Clinic Downtown
state: Indiana
city: Newburgh
country: United States
facility: Chancellor Center for Oncology
state: Indiana
city: Richmond
country: United States
facility: Reid Health
state: Indiana
city: Clive
country: United States
facility: Medical Oncology and Hematology Associates-West Des Moines
state: Iowa
city: Clive
country: United States
facility: Mercy Cancer Center-West Lakes
state: Iowa
city: Council Bluffs
country: United States
facility: Alegent Health Mercy Hospital
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: Mission Cancer and Blood - Laurel
state: Iowa
city: Sioux City
country: United States
facility: Siouxland Regional Cancer Center
state: Iowa
city: West Des Moines
country: United States
facility: Mercy Medical Center-West Lakes
state: Iowa
city: Chanute
country: United States
facility: Cancer Center of Kansas - Chanute
state: Kansas
city: Dodge City
country: United States
facility: Cancer Center of Kansas - Dodge City
state: Kansas
city: El Dorado
country: United States
facility: Cancer Center of Kansas - El Dorado
state: Kansas
city: Fort Scott
country: United States
facility: Cancer Center of Kansas - Fort Scott
state: Kansas
city: Independence
country: United States
facility: Cancer Center of Kansas-Independence
state: Kansas
city: Kingman
country: United States
facility: Cancer Center of Kansas-Kingman
state: Kansas
city: Lawrence
country: United States
facility: Lawrence Memorial Hospital
state: Kansas
city: Liberal
country: United States
facility: Cancer Center of Kansas-Liberal
state: Kansas
city: Manhattan
country: United States
facility: Cancer Center of Kansas-Manhattan
state: Kansas
city: McPherson
country: United States
facility: Cancer Center of Kansas - McPherson
state: Kansas
city: Newton
country: United States
facility: Cancer Center of Kansas - Newton
state: Kansas
city: Parsons
country: United States
facility: Cancer Center of Kansas - Parsons
state: Kansas
city: Pratt
country: United States
facility: Cancer Center of Kansas - Pratt
state: Kansas
city: Salina
country: United States
facility: Cancer Center of Kansas - Salina
state: Kansas
city: Wellington
country: United States
facility: Cancer Center of Kansas - Wellington
state: Kansas
city: Wichita
country: United States
facility: Cancer Center of Kansas-Wichita Medical Arts Tower
state: Kansas
city: Wichita
country: United States
facility: Ascension Via Christi Hospitals Wichita
state: Kansas
city: Wichita
country: United States
facility: Cancer Center of Kansas - Wichita
state: Kansas
city: Winfield
country: United States
facility: Cancer Center of Kansas - Winfield
state: Kansas
city: Bardstown
country: United States
facility: Flaget Memorial Hospital
state: Kentucky
city: Corbin
country: United States
facility: Commonwealth Cancer Center-Corbin
state: Kentucky
city: Lexington
country: United States
facility: Saint Joseph Radiation Oncology Resource Center
state: Kentucky
city: Lexington
country: United States
facility: Saint Joseph Hospital East
state: Kentucky
city: London
country: United States
facility: Saint Joseph London
state: Kentucky
city: Louisville
country: United States
facility: Jewish Hospital
state: Kentucky
city: Louisville
country: United States
facility: Saints Mary and Elizabeth Hospital
state: Kentucky
city: Louisville
country: United States
facility: UofL Health Medical Center Northeast
state: Kentucky
city: Shepherdsville
country: United States
facility: Jewish Hospital Medical Center South
state: Kentucky
city: Springfield
country: United States
facility: Mercy Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: Saint Joseph Mercy Hospital
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: Brighton
country: United States
facility: Saint Joseph Mercy Brighton
state: Michigan
city: Brighton
country: United States
facility: Trinity Health IHA Medical Group Hematology Oncology - Brighton
state: Michigan
city: Canton
country: United States
facility: Saint Joseph Mercy Canton
state: Michigan
city: Canton
country: United States
facility: Trinity Health IHA Medical Group Hematology Oncology - Canton
state: Michigan
city: Caro
country: United States
facility: Caro Cancer Center
state: Michigan
city: Chelsea
country: United States
facility: Saint Joseph Mercy Chelsea
state: Michigan
city: Chelsea
country: United States
facility: Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
state: Michigan
city: Clarkston
country: United States
facility: Hematology Oncology Consultants-Clarkston
state: Michigan
city: Clarkston
country: United States
facility: Newland Medical Associates-Clarkston
state: Michigan
city: Dearborn
country: United States
facility: Beaumont Hospital - Dearborn
state: Michigan
city: Detroit
country: United States
facility: Wayne State University/Karmanos Cancer Institute
state: Michigan
city: Detroit
country: United States
facility: Ascension Saint John Hospital
state: Michigan
city: East China Township
country: United States
facility: Great Lakes Cancer Management Specialists-Doctors Park
state: Michigan
city: Farmington Hills
country: United States
facility: Weisberg Cancer Treatment Center
state: Michigan
city: Flint
country: United States
facility: Genesee Cancer and Blood Disease Treatment Center
state: Michigan
city: Flint
country: United States
facility: Genesee Hematology Oncology PC
state: Michigan
city: Flint
country: United States
facility: Genesys Hurley Cancer Institute
state: Michigan
city: Flint
country: United States
facility: Hurley Medical Center
state: Michigan
city: Grosse Pointe Woods
country: United States
facility: Academic Hematology Oncology Specialists
state: Michigan
city: Grosse Pointe Woods
country: United States
facility: Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
state: Michigan
city: Grosse Pointe Woods
country: United States
facility: Michigan Breast Specialists-Grosse Pointe Woods
state: Michigan
city: Jackson
country: United States
facility: Allegiance Health
state: Michigan
city: Lansing
country: United States
facility: Sparrow Hospital
state: Michigan
city: Livonia
country: United States
facility: Hope Cancer Clinic
state: Michigan
city: Livonia
country: United States
facility: Trinity Health Saint Mary Mercy Livonia Hospital
state: Michigan
city: Macomb
country: United States
facility: Great Lakes Cancer Management Specialists-Macomb Medical Campus
state: Michigan
city: Macomb
country: United States
facility: Michigan Breast Specialists-Macomb Township
state: Michigan
city: Marlette
country: United States
facility: Saint Mary's Oncology/Hematology Associates of Marlette
state: Michigan
city: Monroe
country: United States
facility: Monroe Cancer Center
state: Michigan
city: Pontiac
country: United States
facility: 21st Century Oncology-Pontiac
state: Michigan
city: Pontiac
country: United States
facility: Hope Cancer Center
state: Michigan
city: Pontiac
country: United States
facility: Newland Medical Associates-Pontiac
state: Michigan
city: Pontiac
country: United States
facility: Saint Joseph Mercy Oakland
state: Michigan
city: Port Huron
country: United States
facility: Huron Medical Center PC
state: Michigan
city: Port Huron
country: United States
facility: Lake Huron Medical Center
state: Michigan
city: Rochester Hills
country: United States
facility: Great Lakes Cancer Management Specialists-Rochester Hills
state: Michigan
city: Saginaw
country: United States
facility: Ascension Saint Mary's Hospital
state: Michigan
city: Saginaw
country: United States
facility: Oncology Hematology Associates of Saginaw Valley PC
state: Michigan
city: Sterling Heights
country: United States
facility: Bhadresh Nayak MD PC-Sterling Heights
state: Michigan
city: Tawas City
country: United States
facility: Ascension Saint Joseph Hospital
state: Michigan
city: Warren
country: United States
facility: Advanced Breast Care Center PLLC
state: Michigan
city: Warren
country: United States
facility: Great Lakes Cancer Management Specialists-Macomb Professional Building
state: Michigan
city: Warren
country: United States
facility: Macomb Hematology Oncology PC
state: Michigan
city: Warren
country: United States
facility: Michigan Breast Specialists-Warren
state: Michigan
city: Warren
country: United States
facility: Saint John Macomb-Oakland Hospital
state: Michigan
city: West Branch
country: United States
facility: Saint Mary's Oncology/Hematology Associates of West Branch
state: Michigan
city: Ypsilanti
country: United States
facility: Huron Gastroenterology PC
state: Michigan
city: Ypsilanti
country: United States
facility: Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
state: Michigan
city: Bemidji
country: United States
facility: Sanford Joe Lueken Cancer Center
state: Minnesota
city: Brainerd
country: United States
facility: Essentia Health Saint Joseph's Medical Center
state: Minnesota
city: Burnsville
country: United States
facility: Fairview Ridges Hospital
state: Minnesota
city: Coon Rapids
country: United States
facility: Mercy Hospital
state: Minnesota
city: Deer River
country: United States
facility: Essentia Health - Deer River Clinic
state: Minnesota
city: Detroit Lakes
country: United States
facility: Essentia Health Saint Mary's - Detroit Lakes Clinic
state: Minnesota
city: Duluth
country: United States
facility: Essentia Health Cancer Center
state: Minnesota
city: Duluth
country: United States
facility: Essentia Health Saint Mary's Medical Center
state: Minnesota
city: Duluth
country: United States
facility: Miller-Dwan Hospital
state: Minnesota
city: Edina
country: United States
facility: Fairview Southdale Hospital
state: Minnesota
city: Fergus Falls
country: United States
facility: Lake Region Healthcare Corporation-Cancer Care
state: Minnesota
city: Fosston
country: United States
facility: Essentia Health - Fosston
state: Minnesota
city: Fridley
country: United States
facility: Unity Hospital
state: Minnesota
city: Hibbing
country: United States
facility: Essentia Health Hibbing Clinic
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: Monticello
country: United States
facility: Monticello Cancer Center
state: Minnesota
city: New Ulm
country: United States
facility: New Ulm Medical Center
state: Minnesota
city: Park Rapids
country: United States
facility: Essentia Health - Park Rapids
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: Sandstone
country: United States
facility: Essentia Health Sandstone
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: Thief River Falls
country: United States
facility: Sanford Thief River Falls Medical Center
state: Minnesota
city: Virginia
country: United States
facility: Essentia Health Virginia Clinic
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: Worthington
country: United States
facility: Sanford Cancer Center Worthington
state: Minnesota
city: Wyoming
country: United States
facility: Fairview Lakes Medical Center
state: Minnesota
city: Ballwin
country: United States
facility: Saint Louis Cancer and Breast Institute-Ballwin
state: Missouri
city: Bolivar
country: United States
facility: Central Care Cancer Center - Bolivar
state: Missouri
city: Bonne Terre
country: United States
facility: Parkland Health Center-Bonne Terre
state: Missouri
city: Branson
country: United States
facility: Cox Cancer Center Branson
state: Missouri
city: Cape Girardeau
country: United States
facility: Saint Francis Medical Center
state: Missouri
city: Cape Girardeau
country: United States
facility: Southeast Cancer Center
state: Missouri
city: Jefferson City
country: United States
facility: Capital Region Southwest Campus
state: Missouri
city: Joplin
country: United States
facility: Freeman Health System
state: Missouri
city: Joplin
country: United States
facility: Mercy Hospital Joplin
state: Missouri
city: Rolla
country: United States
facility: Delbert Day Cancer Institute at PCRMC
state: Missouri
city: Rolla
country: United States
facility: Mercy Clinic-Rolla-Cancer and Hematology
state: Missouri
city: Saint Joseph
country: United States
facility: Heartland Regional Medical Center
state: Missouri
city: Saint Louis
country: United States
facility: Saint Louis Cancer and Breast Institute-South City
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: 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: Missouri Baptist Outpatient Center-Sunset Hills
state: Missouri
city: Washington
country: United States
facility: Mercy Hospital Washington
state: Missouri
city: Anaconda
country: United States
facility: Community Hospital of Anaconda
state: Montana
city: Billings
country: United States
facility: Billings Clinic Cancer Center
state: Montana
city: Bozeman
country: United States
facility: Bozeman Deaconess Hospital
state: Montana
city: Great Falls
country: United States
facility: Benefis Healthcare- Sletten Cancer Institute
state: Montana
city: Great Falls
country: United States
facility: Great Falls Clinic
state: Montana
city: Helena
country: United States
facility: Saint Peter's Community Hospital
state: Montana
city: Kalispell
country: United States
facility: Kalispell Regional Medical Center
state: Montana
city: Missoula
country: United States
facility: Community Medical Hospital
state: Montana
city: Grand Island
country: United States
facility: CHI Health Saint Francis
state: Nebraska
city: Kearney
country: United States
facility: Heartland Hematology and Oncology
state: Nebraska
city: Kearney
country: United States
facility: CHI Health Good Samaritan
state: Nebraska
city: Lincoln
country: United States
facility: Saint Elizabeth Regional Medical Center
state: Nebraska
city: Omaha
country: United States
facility: Alegent Health Immanuel Medical Center
state: Nebraska
city: Omaha
country: United States
facility: Hematology and Oncology Consultants PC
state: Nebraska
city: Omaha
country: United States
facility: Alegent Health Bergan Mercy Medical Center
state: Nebraska
city: Omaha
country: United States
facility: Alegent Health Lakeside Hospital
state: Nebraska
city: Omaha
country: United States
facility: Creighton University Medical Center
state: Nebraska
city: Papillion
country: United States
facility: Midlands Community Hospital
state: Nebraska
city: Carson City
country: United States
facility: Carson Tahoe Regional Medical Center
state: Nevada
city: Henderson
country: United States
facility: Cancer and Blood Specialists-Henderson
state: Nevada
city: Henderson
country: United States
facility: Comprehensive Cancer Centers of Nevada - Henderson
state: Nevada
city: Henderson
country: United States
facility: Comprehensive Cancer Centers of Nevada-Horizon Ridge
state: Nevada
city: Henderson
country: United States
facility: Las Vegas Cancer Center-Henderson
state: Nevada
city: Henderson
country: United States
facility: OptumCare Cancer Care at Seven Hills
state: Nevada
city: Henderson
country: United States
facility: Comprehensive Cancer Centers of Nevada-Southeast Henderson
state: Nevada
city: Henderson
country: United States
facility: GenesisCare USA - Henderson
state: Nevada
city: Las Vegas
country: United States
facility: Desert West Surgery
state: Nevada
city: Las Vegas
country: United States
facility: OptumCare Cancer Care at Charleston
state: Nevada
city: Las Vegas
country: United States
facility: University Medical Center of Southern Nevada
state: Nevada
city: Las Vegas
country: United States
facility: Cancer and Blood Specialists-Shadow
state: Nevada
city: Las Vegas
country: United States
facility: Radiation Oncology Centers of Nevada Central
state: Nevada
city: Las Vegas
country: United States
facility: GenesisCare USA - Las Vegas
state: Nevada
city: Las Vegas
country: United States
facility: HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
state: Nevada
city: Las Vegas
country: United States
facility: HealthCare Partners Medical Group Oncology/Hematology-San Martin
state: Nevada
city: Las Vegas
country: United States
facility: Radiation Oncology Centers of Nevada Southeast
state: Nevada
city: Las Vegas
country: United States
facility: Cancer Therapy and Integrative Medicine
state: Nevada
city: Las Vegas
country: United States
facility: Ann M Wierman MD LTD
state: Nevada
city: Las Vegas
country: United States
facility: Cancer and Blood Specialists-Tenaya
state: Nevada
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada - Northwest
state: Nevada
city: Las Vegas
country: United States
facility: GenesisCare USA - Vegas Tenaya
state: Nevada
city: Las Vegas
country: United States
facility: HealthCare Partners Medical Group Oncology/Hematology-Tenaya
state: Nevada
city: Las Vegas
country: United States
facility: OptumCare Cancer Care at MountainView
state: Nevada
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada-Summerlin
state: Nevada
city: Las Vegas
country: United States
facility: Summerlin Hospital Medical Center
state: Nevada
city: Las Vegas
country: United States
facility: Las Vegas Cancer Center-Medical Center
state: Nevada
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Las Vegas
country: United States
facility: GenesisCare USA - Fort Apache
state: Nevada
city: Las Vegas
country: United States
facility: OptumCare Cancer Care at Fort Apache
state: Nevada
city: Las Vegas
country: United States
facility: HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
state: Nevada
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada - Central Valley
state: Nevada
city: Las Vegas
country: United States
facility: University Cancer Center
state: Nevada
city: Pahrump
country: United States
facility: Hope Cancer Care of Nevada-Pahrump
state: Nevada
city: Reno
country: United States
facility: Renown Regional Medical Center
state: Nevada
city: Reno
country: United States
facility: Saint Mary's Regional Medical Center
state: Nevada
city: Reno
country: United States
facility: Radiation Oncology Associates
state: Nevada
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center-Einstein Campus
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center-Weiler Hospital
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center - Moses Campus
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Clinton
country: United States
facility: Southeastern Medical Oncology Center-Clinton
state: North Carolina
city: Goldsboro
country: United States
facility: Southeastern Medical Oncology Center-Goldsboro
state: North Carolina
city: Goldsboro
country: United States
facility: Wayne Memorial Hospital
state: North Carolina
city: Jacksonville
country: United States
facility: Onslow Memorial Hospital
state: North Carolina
city: Jacksonville
country: United States
facility: Southeastern Medical Oncology Center-Jacksonville
state: North Carolina
city: Bismarck
country: United States
facility: Sanford Bismarck Medical Center
state: North Dakota
city: Fargo
country: United States
facility: Essentia Health Cancer Center-South University Clinic
state: North Dakota
city: Fargo
country: United States
facility: Sanford South University 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: Jamestown
country: United States
facility: Essentia Health - Jamestown Clinic
state: North Dakota
city: Beavercreek
country: United States
facility: Indu and Raj Soin Medical Center
state: Ohio
city: Centerville
country: United States
facility: Dayton Physicians LLC-Miami Valley South
state: Ohio
city: Centerville
country: United States
facility: Miami Valley Hospital South
state: Ohio
city: Cincinnati
country: United States
facility: Good Samaritan Hospital - Cincinnati
state: Ohio
city: Cincinnati
country: United States
facility: Oncology Hematology Care Inc-Kenwood
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: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
city: Dayton
country: United States
facility: Good Samaritan Hospital - Dayton
state: Ohio
city: Dayton
country: United States
facility: Miami Valley Hospital
state: Ohio
city: Dayton
country: United States
facility: Dayton Physician LLC-Miami Valley Hospital North
state: Ohio
city: Dayton
country: United States
facility: Miami Valley Hospital North
state: Ohio
city: Findlay
country: United States
facility: Armes Family Cancer Center
state: Ohio
city: Findlay
country: United States
facility: Blanchard Valley Hospital
state: Ohio
city: Findlay
country: United States
facility: Orion Cancer Care
state: Ohio
city: Franklin
country: United States
facility: Atrium Medical Center-Middletown Regional Hospital
state: Ohio
city: Franklin
country: United States
facility: Dayton Physicians LLC-Atrium
state: Ohio
city: Greenville
country: United States
facility: Dayton Physicians LLC-Wayne
state: Ohio
city: Greenville
country: United States
facility: Wayne Hospital
state: Ohio
city: Kettering
country: United States
facility: Greater Dayton Cancer Center
state: Ohio
city: Kettering
country: United States
facility: First Dayton Cancer Care
state: Ohio
city: Kettering
country: United States
facility: Kettering Medical Center
state: Ohio
city: Middletown
country: United States
facility: Dayton Physicians LLC-Signal Point
state: Ohio
city: Sidney
country: United States
facility: Dayton Physicians LLC-Wilson
state: Ohio
city: Springfield
country: United States
facility: Springfield Regional Cancer Center
state: Ohio
city: Springfield
country: United States
facility: Springfield Regional Medical Center
state: Ohio
city: Sylvania
country: United States
facility: ProMedica Flower Hospital
state: Ohio
city: Troy
country: United States
facility: Dayton Physicians LLC-Upper Valley
state: Ohio
city: Troy
country: United States
facility: Upper Valley Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Mercy Hospital Oklahoma City
state: Oklahoma
city: Baker City
country: United States
facility: Saint Alphonsus Medical Center-Baker City
state: Oregon
city: Ontario
country: United States
facility: Saint Alphonsus Medical Center-Ontario
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Hospital-Cedar Crest
state: Pennsylvania
city: Bethlehem
country: United States
facility: Lehigh Valley Hospital - Muhlenberg
state: Pennsylvania
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: Chattanooga
country: United States
facility: Memorial Hospital
state: Tennessee
city: Hixson
country: United States
facility: Pulmonary Medicine Center of Chattanooga-Hixson
state: Tennessee
city: Ooltewah
country: United States
facility: Memorial GYN Plus
state: Tennessee
city: Bryan
country: United States
facility: Saint Joseph Regional Cancer Center
state: Texas
city: Martinsville
country: United States
facility: Sovah Health Martinsville
state: Virginia
city: Bremerton
country: United States
facility: Harrison HealthPartners Hematology and Oncology-Bremerton
state: Washington
city: Bremerton
country: United States
facility: Harrison Medical Center
state: Washington
city: Burien
country: United States
facility: Highline Medical Center-Main Campus
state: Washington
city: Enumclaw
country: United States
facility: Saint Elizabeth Hospital
state: Washington
city: Federal Way
country: United States
facility: Saint Francis Hospital
state: Washington
city: Lakewood
country: United States
facility: Saint Clare Hospital
state: Washington
city: Poulsbo
country: United States
facility: Harrison HealthPartners Hematology and Oncology-Poulsbo
state: Washington
city: Tacoma
country: United States
facility: Franciscan Research Center-Northwest Medical Plaza
state: Washington
city: Tacoma
country: United States
facility: Northwest Medical Specialties PLLC
state: Washington
city: Bridgeport
country: United States
facility: United Hospital Center
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: Ashland
country: United States
facility: Duluth Clinic Ashland
state: Wisconsin
city: Ashland
country: United States
facility: Northwest Wisconsin Cancer Center
state: Wisconsin
city: Chippewa Falls
country: United States
facility: Marshfield Clinic-Chippewa Center
state: Wisconsin
city: Eau Claire
country: United States
facility: Marshfield Medical Center-EC Cancer Center
state: Wisconsin
city: Ladysmith
country: United States
facility: Marshfield Clinic - Ladysmith Center
state: Wisconsin
city: Marshfield
country: United States
facility: Marshfield Medical Center-Marshfield
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Minocqua
country: United States
facility: Marshfield Clinic-Minocqua Center
state: Wisconsin
city: New Richmond
country: United States
facility: Cancer Center of Western Wisconsin
state: Wisconsin
city: Rice Lake
country: United States
facility: Marshfield Medical Center-Rice Lake
state: Wisconsin
city: Stevens Point
country: United States
facility: Marshfield Medical Center-River Region at Stevens Point
state: Wisconsin
city: Wausau
country: United States
facility: Marshfield Clinic-Wausau Center
state: Wisconsin
city: Weston
country: United States
facility: Marshfield Medical Center - Weston
state: Wisconsin
city: Wisconsin Rapids
country: United States
facility: Marshfield Clinic - Wisconsin Rapids Center
state: Wisconsin
city: Cody
country: United States
facility: Billings Clinic-Cody
state: Wyoming
city: Sheridan
country: United States
facility: Welch Cancer Center
state: Wyoming
Study officials:
affiliation: ECOG-ACRIN Cancer Research Group
name: Lakshmi Rajdev
role: PRINCIPAL_INVESTIGATOR
References: