Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Breast Cancer, Non-small Cell Lung Cancer, or Prostate Cancer



Status:Active, not recruiting
Conditions:Breast Cancer, Lung Cancer, Lung Cancer, Prostate Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/10/2019
Start Date:August 2014
End Date:February 2023

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A Phase 1 Study of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Multiple Metastases

This phase I trial studies the side effects and the best dose of stereotactic body radiation
therapy in treating patients with breast cancer, non-small cell lung cancer, or prostate
cancer that has spread to other parts of the body. Stereotactic body radiation therapy
delivers fewer, tightly-focused, high doses of radiation therapy to all known sites of cancer
in the body while minimizing radiation exposure of surrounding normal tissue.

PRIMARY OBJECTIVES:

I. To determine the recommended stereotactic body radiation therapy (SBRT) dose for each of
the metastatic locations being treated given the individual and overlapping fields when
multiple metastases are treated with SBRT in a national clinical trials network setting.

SECONDARY OBJECTIVES:

I. To estimate rates of >= grade 3 Common Terminology Criteria for Adverse Events (CTCAE),
version (v.) 4.0 adverse events other than a dose-limiting toxicity (DLT) which is possibly,
probably, or definitely related to treatment and which occurs within 6 months from the start
of SBRT to multiple metastases.

II. To estimate the rates of long-term adverse events occurring up to 2 years from the end of
SBRT.

III. To explore the most appropriate and clinically relevant technological parameters to
ensure quality and effectiveness throughout radiation therapy processes, including imaging,
simulation, patient immobilization, target and critical structure definition, treatment
planning, image guidance and delivery.

OUTLINE:

Patients undergo 3-5 fractions of image-guided stereotactic body radiation therapy to all
existing metastases over 1-3 weeks with at least 40 hours between treatments for an
individual metastasis.

After completion of study treatment, patients are followed up at 35-45 days and then every 3
months for 2 years.

Inclusion Criteria:

- Metastatic breast cancer (MBC) OR metastatic non-small cell lung cancer (NSCLC) OR
metastatic adenocarcinoma of the prostate; the sites of allowed metastases are:
peripheral lung, central lung, mediastinal/cervical lymph node, liver,
spinal/paraspinal, osseous, and abdominal-pelvic

- NOTE: after the required number of evaluable patients have been accrued for a
given dose level, the accrual for that metastatic location will be temporarily
suspended while the safety of that dose level is assessed; a patient can only be
entered onto the trial if all of their metastatic locations are open to accrual
(e.g. if central lung is temporarily suspended for safety assessment and the
patient has a central lung metastases, regardless of other metastases, they
cannot enroll until the safety of dose to central lung is determined)

- Primary tumor site without progression at registration

- All metastases not resected must be amenable to SBRT

- The patient must meet ONE of the three following criteria:

- 3-4 radiographically distinct metastases of any distribution in the allowed
anatomical sites OR

- 2 radiographically distinct metastases that must be anatomically close (i.e.,
with less than or equal to 5 cm of normal tissue between them) OR

- 3 or 4 distinct metastasis, 2 or 3 to be treated with SBRT and the other (s)
having been surgically removed

- Evaluation by a radiation oncologist within 45 days prior to study registration

- Evaluation by a medical oncologist within 45 days prior to study registration

- The following imaging workup to document metastases within 45 days prior to study
registration:

- Computed tomography (CT) scans of the chest, abdomen and pelvis with radionuclide
bone scan OR whole body positron emission tomography (PET)/CT

- History/physical examination within 45 days prior to study registration

- Zubrod performance status =< 2 within 45 days prior to study registration

- Age >= 18 years

- Absolute neutrophil count (ANC) >= 500 cells/mm^3

- Platelets >= 50,000 /mm^3

- Hemoglobin >= 8.0 g/dl (Note: the use of transfusion or other intervention to achieve
hemoglobin [Hgb] >= 8.0 g/dl is acceptable)

- If liver metastases present, aspartate aminotransferase (AST) and alanine
aminotransferase (ALT) must be < 3 x upper limit of normal (ULN)

- Patient must provide study specific informed consent prior to study entry

- For females of child-bearing potential, negative serum/urine pregnancy test within 14
days prior to study registration

Exclusion Criteria:

- Progression of primary tumor site (breast, prostate, or lung) at time of registration

- Metastases with indistinct borders making targeting not feasible

- Known brain metastases

- Prior palliative radiotherapy to metastases

- Metastases located within 3 cm of the previously irradiated structures:

- Spinal cord previously irradiated to > 40 Gy (delivered in =< 3 Gy/fraction)

- Brachial plexus previously irradiated to > 50 Gy (delivered in =< 3 Gy/fraction)

- Small intestine, large intestine, or stomach previously irradiated to > 45 Gy
(delivered in =< 3 Gy/fraction)

- Brain stem previously irradiated to > 50 Gy (delivered in =< 3 Gy/fraction)

- Whole lung previously irradiated with prior volume 20 Gy (V20Gy) > 30% (delivered
in =< 3 Gy/fraction)

- Primary tumor irradiated with SBRT

- Metastasis irradiated with SBRT

- Severe, active co-morbidity, defined as follows:

- Unstable angina and/or congestive heart failure requiring hospitalization within
the last 6 months prior to registration

- Transmural myocardial infarction within the last 6 months prior to registration

- Acute bacterial or fungal infection requiring intravenous antibiotics at the time
of registration

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy within 30 days prior to
registration

- Severe hepatic disease, defined as a diagnosis of Child-Pugh class B or C hepatic
disease

- Human immunodeficiency virus (HIV) positive with cluster of differentiation (CD)
4 count < 200 cells/microliter; note that patients who are HIV positive are
eligible, provided they are under treatment with highly active antiretroviral
therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior
to registration; note also that HIV testing is not required for eligibility for
this protocol

- End-stage renal disease (i.e., on dialysis or dialysis has been recommended)

- Pregnancy or women of childbearing potential not willing/able to use medically
acceptable forms of contraception during protocol treatment or for at least 6 months
following treatment
We found this trial at
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7 Executive Woods Court
Swansea, Illinois 62226
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Swansea, IL
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
Principal Investigator: Gregory N. Gan
Phone: 505-925-0366
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
651
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Albuquerque, NM
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1500 E Duarte Rd
Duarte, California 91010
(626) 256-4673
Principal Investigator: Savita V. Dandapani
Phone: 800-826-4673
City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
4
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Duarte, CA
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655 West 8th Street
Jacksonville, Florida 32209
2129
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Jacksonville, FL
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Principal Investigator: Yuhchyau Chen
Phone: 585-341-8113
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Rochester, NY
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Anderson, Indiana 46016
Principal Investigator: Alexander M. Yeh
Phone: 765-646-8358
1818
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Anderson, IN
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
Principal Investigator: Daniel E. Spratt
Phone: 734-763-7370
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
1932
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Ann Arbor, MI
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Arlington Heights, Illinois 60005
Principal Investigator: Stephen S. Nigh
Phone: 847-618-4968
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Arlington Heights, IL
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Atlanta, Georgia 30303
Principal Investigator: Pretesh R. Patel
Phone: 404-778-1868
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550 Peachtree St NE
Atlanta, Georgia 30308
(404) 686-4411
Principal Investigator: Pretesh R. Patel
Phone: 404-778-1868
Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...
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Atlanta, Georgia 30322
Principal Investigator: Pretesh R. Patel
Phone: 404-778-1868
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12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
Principal Investigator: Rachel A. Rabinovitch
Phone: 720-848-0650
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
825
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Aurora, CO
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22 South Greene Street
Baltimore, Maryland 21201
410-328-7904
Principal Investigator: Steven J. Feigenberg
Phone: 800-888-8823
University of Maryland Greenebaum Cancer Center The University of Maryland Marlene and Stewart Greenebaum Cancer...
2301
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Baltimore, MD
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Bel Air, Maryland 21014
Principal Investigator: Navesh K. Sharma
Phone: 800-888-8823
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Bel Air, MD
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8901 Rockville Pike
Bethesda, Maryland 20889
(301) 295-4000
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
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Birmingham, Alabama 35233
Principal Investigator: Jennifer F. De Los Santos
Phone: 800-828-8816
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Birmingham, AL
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Boston, Massachusetts 02118
Principal Investigator: Lisa A. Kachnic
Phone: 800-811-8480
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Bronx, New York 10467
Principal Investigator: Nitin Ohri
Phone: 718-904-2730
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: David T. Marshall
Phone: 843-792-9321
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charleston, SC
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: John P. Hayes
Phone: 312-695-1301
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5841 S Maryland Ave
Chicago, Illinois 60637
1-773-702-6180
Principal Investigator: Steven J. Chmura
Phone: 312-355-3046
University of Chicago Comprehensive Cancer Center The University of Chicago Comprehensive Cancer Center (UCCCC) is...
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Cincinnati, Ohio 45219
Principal Investigator: Kevin P. Redmond
Phone: 513-558-4553
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Clarkston, Michigan 48346
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Samuel T. Chao
Phone: 866-223-8100
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Columbus, Ohio 43210
Principal Investigator: Jose G. Bazan
Phone: 800-293-5066
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4050 Coon Rapids Blvd NW
Coon Rapids, Minnesota 55433
(763) 236-6000
Principal Investigator: Paul W. Sperduto
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Mercy Hospital Mercy Hospital, located in Coon Rapids, Minnesota, is a 271-bed non-profit hospital that...
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2300 N Edward St
Decatur, Illinois 62526
(217) 876-8121
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Phone: 309-243-3605
Decatur Memorial Hospital An American flag bearing only 48 stars waved above Decatur Memorial Hospital...
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1200 Pleasant St
Des Moines, Iowa 50309
(515) 241-6212
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Iowa Methodist Medical Center Iowa Methodist Medical Center was established in 1901 in a single...
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Principal Investigator: Eleanor M. Walker
Phone: 313-916-1784
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Drexel Hill, Pennsylvania
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Joseph K. Salama
Phone: 773-834-7424
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Edmonton, Alberta
Principal Investigator: Zsolt Gabos
Phone: 780-432-8500
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28595 Orchard Lake Road
Farmington Hills, Michigan 48334
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Flint, Michigan 48532
Principal Investigator: Kiran Devisetty
Phone: 989-667-6257
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1024 S Lemay Ave
Fort Collins, Colorado 80524
(970) 495-7000
Principal Investigator: Rachel A. Rabinovitch
Phone: 720-848-0650
Poudre Valley Hospital A 270-bed regional medical center offering a wide array of treatments, surgeries,...
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2200 Randallia Drive
Fort Wayne, Indiana 46805
Principal Investigator: Brian K. Chang
Phone: 260-373-8888
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1600 Southwest Archer Road
Gainesville, Florida 32610
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Greenwood, South Carolina 29646
Principal Investigator: David T. Marshall
Phone: 843-792-9321
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Indianapolis, Indiana 46202
Principal Investigator: Gordon A. Watson
Phone: 800-248-1199
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Iowa City, Iowa 52242
Principal Investigator: Mark C. Smith
Phone: 800-237-1225
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La Crosse, Wisconsin
Principal Investigator: Collin D. Driscoll
Phone: 608-775-2385
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3855 Health Sciences Dr,
La Jolla, California 92093
(858) 822-6100
Principal Investigator: James J. Urbanic
Phone: 858-822-5354
UC San Diego Moores Cancer Center Established in 1978, UC San Diego Moores Cancer Center...
95
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450 Lakeville Road
Lake Success, New York 11042
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Lexington, Kentucky
Principal Investigator: Ronald C. McGarry
Phone: 859-257-3379
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1441 Eastlake Ave
Los Angeles, California 90033
(323) 865-3000
Principal Investigator: Naomi R. Schechter
Phone: 323-865-0451
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
11
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Louisville, Kentucky 40202
Principal Investigator: Neal E. Dunlap
Phone: 866-530-5516
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2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Principal Investigator: Abhishek A. Solanki
Phone: 708-202-8387
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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Miami, Florida 33136
Principal Investigator: Lorraine Portelance
Phone: 305-243-2647
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9200 W Wisconsin Ave
Milwaukee, Wisconsin 53226
(414) 805-3666
Principal Investigator: Elizabeth M. Gore
Phone: 414-805-4380
Froedtert and the Medical College of Wisconsin Froedtert Health combines with the Medical College of...
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Milwaukee, Wisconsin 53295
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Phone: 888-469-6614
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Mount Clemens, Michigan 48043
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Mount Holly, New Jersey 08060
Principal Investigator: Lemuel S. Ariaratnam
Phone: 609-914-6762
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Mount Laurel, New Jersey 08054
Principal Investigator: Benjamin Goldsmith
Phone: 856-325-6757
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5475 South 500 East
Ogden, Utah 84405
Principal Investigator: Brandon J. Fisher
Phone: 412-339-5294
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Principal Investigator: Andrew O. Wahl
Phone: 402-559-6941
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Peoria, AZ
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Peoria, Illinois 61637
Principal Investigator: James L. Wade
Phone: 309-243-3605
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Petoskey, MI
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Pontiac, Michigan 48341
Principal Investigator: Samir Narayan
Phone: 208-367-7954
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1015 NW 22nd Ave
Portland, Oregon 97210
(503) 413-7711
Legacy Good Samaritan Hospital and Medical Center Located in the heart of Northwest Portland, Legacy...
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Rochester, Minnesota 55905
Principal Investigator: Sean S. Park
Phone: 855-776-0015
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Sacramento, California 95817
Principal Investigator: Megan E. Daly
Phone: 916-734-3089
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Sacramento, California 95819
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Clifford G. Robinson
Phone: 800-600-3606
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Louis, MO
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2000 Circle of Hope Dr
Salt Lake City, Utah 84112
(801) 585-0303
Huntsman Cancer Institute at University of Utah Huntsman Cancer Institute (HCI) is part of the...
573
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701 N 1st St
Springfield, Illinois 62781
(217) 788-3000
Principal Investigator: James L. Wade
Phone: 309-243-3605
Memorial Medical Center Memorial Medical Center is a Magnet-designated, acute care hospital in Springfield that...
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Toms River, New Jersey 08755
Principal Investigator: David J. D'Ambrosio
Phone: 732-818-3882
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4550 Investment Drive
Troy, Michigan 48098
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Tucson, Arizona 85724
Principal Investigator: Baldassarre Stea
Phone: 520-626-9008
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Voorhees, New Jersey 08043
Principal Investigator: Lemuel S. Ariaratnam
Phone: 609-914-6762
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West Bloomfield, Michigan 48322
Principal Investigator: Eleanor M. Walker
Phone: 313-916-1784
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West Chester, Ohio 45069
Principal Investigator: Kevin P. Redmond
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300 South 6th Avenue
West Reading, Pennsylvania 19611
(610) 988-8000
Principal Investigator: Terrence P. Cescon
Phone: 610-988-9323
Reading Hospital At Reading Health System, advancing your health and wellness is our mission. When...
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929 N St Francis St
Wichita, Kansas 67214
(316) 268-5775
Principal Investigator: Shaker R. Dakhil
Phone: 316-268-5374
Via Christi Regional Medical Center Via Christi Health's rich history of serving the people of...
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
2129
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