Dose-Escalated Photon IMRT or Proton Beam Radiation Therapy Versus Standard-Dose Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma



Status:Recruiting
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/31/2019
Start Date:October 27, 2014
End Date:May 2024

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Randomized Phase II Trial of Hypofractionated Dose-Escalated Photon IMRT or Proton Beam Therapy Versus Conventional Photon Irradiation With Concomitant and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma

This randomized phase II trial studies how well dose-escalated photon intensity-modulated
radiation therapy (IMRT) or proton beam radiation therapy works compared with standard-dose
radiation therapy when given with temozolomide in patients with newly diagnosed glioblastoma.
Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells
and shrink tumors. Specialized radiation therapy that delivers a high dose of radiation
directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
Drugs, such as temozolomide, may make tumor cells more sensitive to radiation therapy. It is
not yet known whether dose-escalated photon IMRT or proton beam radiation therapy is more
effective than standard-dose radiation therapy with temozolomide in treating glioblastoma.

PRIMARY OBJECTIVES:

I. To determine if dose-escalated and -intensified photon IMRT or proton beam therapy (using
a dose-per-fraction escalation with simultaneous integrated boost) with concomitant and
adjuvant temozolomide improves overall survival, as compared to standard-dose photon
irradiation with concomitant and adjuvant temozolomide.

SECONDARY OBJECTIVES:

I. To indirectly compare dose-escalated and -intensified photon IMRT to dose-escalated and
-intensified proton beam therapy in terms of overall survival.

II. To indirectly compare and record toxicities of dose-escalated and -intensified photon
IMRT versus dose-escalated and -intensified proton beam therapy and directly compare the
toxicities of these approaches versus standard-dose photon irradiation on the backbone of
concomitant and adjuvant temozolomide.

III. To indirectly determine if dose-escalated and -intensified proton beam therapy with
concomitant and adjuvant temozolomide improves perceived cognitive symptom severity, as
compared to dose-escalated and -intensified photon IMRT, and to directly compare symptom
burden with these approaches versus standard-dose photon irradiation on the backbone of
concomitant and adjuvant temozolomide.

IV. To indirectly determine if dose-escalated and -intensified proton beam therapy with
concomitant and adjuvant temozolomide improves neurocognitive function, as compared to
dose-escalated and -intensified photon IMRT, and to directly compare neurocognitive function
with these approaches versus standard-dose photon irradiation on the backbone of concomitant
and adjuvant temozolomide.

TERTIARY OBJECTIVES:

I. Tissue banking for future translational science projects that will be determined based on
the state of the science at the time the primary endpoint is reported and will be submitted
to National Cancer Institute (NCI) for review and approval.

II. To prospectively compare cluster of differentiation (CD)4 lymphopenia between
dose-escalated and intensified proton beam therapy, dose-escalated and -intensified photon
IMRT, and standard-dose photon irradiation.

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.

- To establish feasibility and clinical relevancy of quality assurance guidelines.

- To evaluate efficacy of quality assurance tools.

OUTLINE: Patients are assigned to 1 of 2 groups depending on enrolling institution. Within
each group, patients will be randomized 1:2 in favor of the experimental arms.

GROUP I (PHOTON IMRT CENTERS): Patients are randomized to 1 of 2 treatment arms.

ARM A1: Patients undergo standard-dose photon irradiation using 3-dimensional conformal
radiation therapy (3D-CRT) or IMRT once daily (QD), 5 days a week for 23 fractions plus a
boost of 7 additional fractions.

ARM B: Patients undergo dose-escalated and -intensified photon IMRT QD, 5 days a week for a
total of 30 fractions.

GROUP II (PROTON CENTERS): Patients are randomized to 1 of 2 treatment arms.

ARM A2: Patients undergo standard-dose photon irradiation using 3D-CRT or IMRT as in Arm A1.

ARM C: Patients undergo dose-escalated and -intensified proton beam radiation therapy QD, 5
days a week for a total of 30 fractions.

In all treatment arms, patients receive temozolomide orally (PO) QD on days 1-49 of radiation
therapy. Beginning 4 weeks later, patients receive temozolomide PO QD on days 1-5. Treatment
repeats every 28 days for up to 12 courses in the absence of disease progression or
unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 1 year,
every 4 months for 1 year, and then every 6 months thereafter.

Inclusion Criteria:

- PRIOR TO STEP 1 REGISTRATION

- A diagnostic contrast-enhanced magnetic resonance imaging (MRI) (no other scan type
allowed) of the brain must be performed postoperatively within 72 hours of resection;
the enhancing tumor must have a maximal diameter of 5 cm; the tumor diameter will be
the greatest diameter as measured on the contrast-enhanced postoperative MRI and will
include residual disease and/or the postoperative surgical cavity as appropriate; for
cases where residual disease or postoperative surgical cavity is NOT identifiable
(e.g., polar glioblastomas [GBMs] where a polar lobectomy is performed), the patient
will be excluded from the trial

- The GBM tumor must be located in the supratentorial compartment only (any component
involving the brain stem or cerebellum is not allowed)

- Patients must provide study-specific informed consent prior to step 1 registration

- PRIOR TO STEP 2 REGISTRATION

- Histologically proven diagnosis of glioblastoma (World Health Organization [WHO] grade
IV) confirmed by central review prior to step 2 registration

- Tumor tissue that is determined by central pathology review prior to step 2
registration to be of sufficient quantity for analysis of
O6-methylguanin-DNA-methyltransferase (MGMT) status

- Patients must have at least 1 block of tumor tissue; submission of 2 blocks is
strongly encouraged to maximize the chances of eligibility; at least 1 cubic
centimeter of tissue composed primarily of tumor must be present

- Diagnosis must be made by surgical excision, either partial or complete;
stereotactic biopsy or cavitron ultrasonic suction aspirator (CUSA) technique are
not allowed

- History/physical examination within 28 days prior to step 2 registration

- The patient must have recovered from effects of surgery, postoperative infection, and
other complications within 28 days prior to step 2 registration

- Documentation of steroid doses within 28 days prior to step 2 registration

- Karnofsky performance status >= 70 within 28 days prior to step 2 registration

- Age >= 18

- Absolute neutrophil count (ANC) >= 1,800 cells/mm^3

- Platelets >= 100,000 cells/mm^3

- Hemoglobin >= 10.0 g/dl (note: the use of transfusion or other intervention to achieve
hemoglobin (Hgb) >= 10.0 g/dl is acceptable)

- Bilirubin =< 1.5 upper limit of normal (ULN)

- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x ULN

- Negative serum pregnancy test obtained for females of child-bearing potential within
28 days prior to step 2 registration

Exclusion Criteria:

- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease-free
for a minimum of 3 years; (for example, carcinoma in situ of the breast, oral cavity,
or cervix are all permissible)

- Recurrent or multifocal malignant gliomas

- Any site of distant disease (for example, drop metastases from the GBM tumor site)

- Prior chemotherapy or radiosensitizers for cancers of the head and neck region; note
that prior chemotherapy for a different cancer is allowable (except temozolomide)

- Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment are
not permitted

- Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in
overlap of radiation fields

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

- Unstable angina at step 2 registration

- Transmural myocardial infarction within the last 6 months prior to step 2
registration

- Evidence of recent myocardial infarction or ischemia by the findings of S-T
elevations of >= 2 mm using the analysis of an electrocardiogram (EKG) performed
within 28 days prior to step 2 registration

- New York Heart Association grade II or greater congestive heart failure requiring
hospitalization within 12 months prior to step 2 registration

- Serious and inadequately controlled arrhythmia at step 2 registration

- Serious or non-healing wound, ulcer or bone fracture or history of abdominal
fistula, intra-abdominal abscess requiring major surgical procedure, open biopsy
or significant traumatic injury within 28 days prior to step 2 registration, with
the exception of the craniotomy for surgical resection

- Acute bacterial or fungal infection requiring intravenous antibiotics at the time
of step 2 registration

- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects;
note, however, that laboratory tests for coagulation parameters are not required
for entry into this protocol

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy at the time of step 2
registration

- Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease
Control and Prevention (CDC) definition; note, however, that human
immunodeficiency virus (HIV) testing is not required for entry into this protocol

- Any other severe immunocompromised condition

- Active connective tissue disorders, such as lupus or scleroderma, that in the
opinion of the treating physician may put the patient at high risk for radiation
toxicity

- End-stage renal disease (ie, on dialysis or dialysis has been recommended)

- Any other major medical illnesses or psychiatric treatments that in the
investigator's opinion will prevent administration or completion of protocol
therapy

- Pregnancy or women of childbearing potential and men who are sexually active and not
willing/able to use medically acceptable forms of contraception

- Patents treated on any other therapeutic clinical protocols within 30 days prior to
step 2 registration

- Inability to undergo MRI (e.g., due to safety reasons, such as presence of a
pacemaker, or severe claustrophobia)

- Postoperative tumor plus surgical bed size exceeds 5 cm in maximum diameter.
We found this trial at
226
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10900 Euclid Ave
Cleveland, Ohio 44106
216-368-2000
Principal Investigator: Mitchell Machtay
Phone: 800-641-2422
Case Western Reserve Univ Continually ranked among America's best colleges, Case Western Reserve University has...
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: John E. Mignano
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301 University Blvd
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2500 N State St
Jackson, Mississippi 39216
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655 West 8th Street
Jacksonville, Florida 32209
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200 North Park Street
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West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
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529 West Markham Street
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
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401 College Street
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4502 Medical Drive
San Antonio, Texas 78284
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Phone: 210-450-3800
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1 Akron General Avenue
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5301 McAuley Drive
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1500 East Medical Center Drive
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Antigo, Wisconsin 54409
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Asheville, North Carolina 28801
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Atlanta, Georgia 30322
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Auburn, California 95603
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Austin, Texas 78702
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Austin, Texas 78705
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Austin, Texas 78731
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Austin, Texas 78745
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Austin, Texas 78758
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1500 Red River Street
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Bakersfield, California 93301
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22 South Greene Street
Baltimore, Maryland 21201
410-328-7904
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Baltimore, Maryland 21201
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Basking Ridge, New Jersey 07920
Principal Investigator: Mariza Daras
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Beachwood, Ohio 44122
Principal Investigator: Mitchell Machtay
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Bel Air, Maryland 21014
Principal Investigator: Jack J. Hong
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Bemidji, Minnesota 56601
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Berkeley, California 94704
Principal Investigator: Christopher U. Jones
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Berlin, Vermont 05602
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Bethlehem, Pennsylvania 18015
Principal Investigator: Nimisha Deb
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Billings, Montana 59101
Principal Investigator: Benjamin T. Marchello
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Birmingham, Alabama 35233
Principal Investigator: John B. Fiveash
Phone: 205-934-0309
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300 N. Seventh St.
Bismarck, North Dakota 58501
(701) 323-6000
Principal Investigator: Preston D. Steen
Phone: 701-323-5760
Sanford Bismarck Medical Center Whether your stay in our hospital is one day for same...
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Boca Raton, Florida 33486
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Boise, Idaho 83706
Principal Investigator: Samir Narayan
Phone: 734-712-3671
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55 Fruit St
Boston, Massachusetts 02114
(617) 724-4000
Principal Investigator: Helen A. Shih
Phone: 877-726-5130
Massachusetts General Hospital Cancer Center An integral part of one of the world
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Boston, Massachusetts 02118
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Bronx, New York 10467
Principal Investigator: Madhur K. Garg
Phone: 718-904-2730
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263 7th Avenue
Brooklyn, New York 11215
Principal Investigator: Hani L. Ashamalla
Phone: 718-780-3677
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Burlington, Vermont 05405
Principal Investigator: Carl J. Nelson
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Cameron Park, California 95682
Principal Investigator: Christopher U. Jones
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Castro Valley, California 94546
Principal Investigator: Christopher U. Jones
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Cedar Rapids, Iowa 52403
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Chardon, Ohio 44024
Principal Investigator: Mitchell Machtay
Phone: 800-641-2422
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Samuel L. Cooper
Phone: 843-792-9321
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Timothy J. Kruser
Phone: 312-695-1301
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1969 W Ogden Ave
Chicago, Illinois 60612
(312) 864-6000
Principal Investigator: Thomas E. Lad
Phone: 312-864-5204
John H. Stroger, Jr. Hospital of Cook County The Level 1 Trauma Center is one...
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5841 S Maryland Ave
Chicago, Illinois 60637
1-773-702-6180
Principal Investigator: Steven J. Chmura
Phone: 773-702-8222
University of Chicago Comprehensive Cancer Center The University of Chicago Comprehensive Cancer Center (UCCCC) is...
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Aidnag Z. Diaz
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Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Cincinnati, Ohio 45219
Principal Investigator: Jordan Kharofa
Phone: 513-558-4553
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Samuel T. Chao
Phone: 866-223-8100
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18101 Lorain Avenue
Cleveland, Ohio 44111
216.476.7000
Principal Investigator: Samuel T. Chao
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1400 East Boulder Street
Colorado Springs, Colorado 80909
Principal Investigator: Anthony D. Elias
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Columbia, Maryland 21044
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Columbus, Ohio 43210
Principal Investigator: Arnab Chakravarti
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3535 Olentangy River Rd
Columbus, Ohio 43214
(614) 566-5000
Principal Investigator: John P. Kuebler
Phone: 614-488-2745
Riverside Methodist Hospital Serving central Ohio since 1892, Riverside Methodist Hospital is consistently ranked one...
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Commack, New York 11725
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Phone: 631-623-4000
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Dallas, Texas 75390
Principal Investigator: Robert D. Timmerman
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Danvers, Massachusetts 01923
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Dearborn, Michigan 48124
Principal Investigator: Prakash Chinnaiyan
Phone: 313-593-8090
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2300 N Edward St
Decatur, Illinois 62526
(217) 876-8121
Principal Investigator: Bryan A. Faller
Phone: 217-876-4740
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1 Kish Hospital Drive
DeKalb, Illinois 60115
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1200 Pleasant St
Des Moines, Iowa 50309
(515) 241-6212
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Phone: 515-241-3309
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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Duluth, Minnesota 55805
Principal Investigator: Steven R. Bonin
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Dunmore, Pennsylvania 18512
Principal Investigator: Wenyin Shi
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Elyria, Ohio 44035
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Ephrata, Pennsylvania 17522
Principal Investigator: Amit B. Shah
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Eugene, Oregon 97401
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820 4th St N
Fargo, North Dakota 58102
(701) 234-6161
Principal Investigator: Preston D. Steen
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Flint, Michigan 48532
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Flower Mound, Texas 75028
Principal Investigator: Vivek S. Kavadi
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1024 S Lemay Ave
Fort Collins, Colorado 80524
(970) 495-7000
Principal Investigator: Anthony D. Elias
Phone: 970-297-6150
Poudre Valley Hospital A 270-bed regional medical center offering a wide array of treatments, surgeries,...
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Fort Wayne, Indiana 46804
Principal Investigator: Brian K. Chang
Phone: 877-437-2408
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2200 Randallia Drive
Fort Wayne, Indiana 46805
Principal Investigator: Brian K. Chang
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Fort Wayne, Indiana 46845
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Fort Worth, Texas 76104
Principal Investigator: Vivek S. Kavadi
Phone: 281-277-5200
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1600 Southwest Archer Road
Gainesville, Florida 32610
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Geneva, Illinois 60134
Principal Investigator: Vinai Gondi
Phone: 630-315-1918
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Geneva, IL
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40 V-Twin Drive
Gettysburg, Pennsylvania 17325
(717) 339-2640
Principal Investigator: Amit B. Shah
Phone: 877-441-7957
Adams Cancer Center Every day across central Pennsylvania, the people of WellSpan Health work together...
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Gettysburg, PA
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Glen Burnie, Maryland 21061
Principal Investigator: Mark V. Mishra
Phone: 410-553-8100
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Glen Burnie, MD
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Grand Rapids, Michigan 49503
Principal Investigator: Kathleen J. Yost
Phone: 616-391-1230
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Grand Rapids, MI
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100 Michigan St NE
Grand Rapids, Michigan 49503
(616) 391-1774
Principal Investigator: Kathleen J. Yost
Phone: 616-391-1230
Spectrum Health at Butterworth Campus Butterworth Hospital is one of four facilities that make up...
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Grand Rapids, MI
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Greenbrae, California 94904
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Greenbrae, CA
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Greenville, South Carolina 29605
Principal Investigator: Michael D. Zurenko
Phone: 864-241-6251
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Greenville, SC
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Greenville, South Carolina 29615
Principal Investigator: Michael D. Zurenko
Phone: 864-241-6251
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Greenville, SC
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Greenwood, South Carolina 29646
Principal Investigator: Samuel L. Cooper
Phone: 843-792-9321
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Greenwood, SC
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Greer, South Carolina 29650
Principal Investigator: Michael D. Zurenko
Phone: 864-241-6251
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Greer, SC
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24800 SE Stark St
Gresham, Oregon 97030
(503) 674-1122
Principal Investigator: Andrew Y. Kee
Phone: 503-413-2150
Legacy Mount Hood Medical Center Legacy Mount Hood Medical Center, East County's full-service community hospital,...
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Gresham, OR
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4300 Londonderry Road
Harrisburg, Pennsylvania 17109
Principal Investigator: David C. Weksberg
Phone: 717-724-6765
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Harrisburg, PA
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500 Westchester Avenue
Harrison, New York 10604
Principal Investigator: Mariza Daras
Phone: 212-639-7592
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Harrison, NY
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80 Seymour St
Hartford, Connecticut 6102
(860) 545-5000
Principal Investigator: Susan Y. Kim
Phone: 860-545-5363
The Hartford Hospital Hartford Hospital is the major teaching hospital affiliated with the University of...
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Hartford, CT
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Houston, Texas 77024
Principal Investigator: Vivek S. Kavadi
Phone: 281-277-5200
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Houston, TX
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Houston, Texas 77030
Principal Investigator: Andrew J. Bishop
Phone: 877-312-3961
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Houston, TX
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Independence, Ohio 44131
Principal Investigator: Samuel T. Chao
Phone: 866-223-8100
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Independence, OH
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Indianapolis, Indiana 46202
Principal Investigator: Gordon A. Watson
Phone: 317-278-5632
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Indianapolis, IN
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Indianapolis, Indiana 46227
Principal Investigator: Daniel W. Weed
Phone: 317-621-7104
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Indianapolis, IN
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