Radiation Therapy With or Without Olaparib in Treating Patients With Inflammatory Breast Cancer
Status: | Recruiting |
---|---|
Conditions: | Breast Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/6/2019 |
Start Date: | September 12, 2018 |
End Date: | July 31, 2023 |
A Phase II Randomized Trial of Olaparib (NSC-747856) Administered Concurrently With Radiotherapy Versus Radiotherapy Alone for Inflammatory Breast Cancer
This phase II trial studies how well radiation therapy with or without olaparib works in
treating patients with inflammatory breast cancer. Radiation therapy uses high energy x-rays
to kill tumor cells and shrink tumors. Olaparib may stop the growth of tumor cells by
blocking some of the enzymes needed for cell growth. It is not yet known whether radiation
therapy with or without olaparib may work better in treating patients with inflammatory
breast cancer.
treating patients with inflammatory breast cancer. Radiation therapy uses high energy x-rays
to kill tumor cells and shrink tumors. Olaparib may stop the growth of tumor cells by
blocking some of the enzymes needed for cell growth. It is not yet known whether radiation
therapy with or without olaparib may work better in treating patients with inflammatory
breast cancer.
PRIMARY OBJECTIVES:
I. To compare the Invasive Disease-Free Survival (IDFS) of patients with inflammatory breast
cancer receiving concurrent administration of olaparib with standard doses of radiotherapy to
the chest wall and regional lymph nodes compared to standard doses of radiotherapy alone to
the chest wall and regional lymph nodes.
SECONDARY OBJECTIVES:
I. To compare the effect of concurrent administration of olaparib with radiotherapy versus
radiotherapy alone on improvement in locoregional control (measured by Locoregional
Recurrence-Free Interval), Distant Relapse-Free Survival, and Overall Survival in
inflammatory breast cancer patients.
ADDITIONAL OBJECTIVES:
I. To collect tissue and whole blood for processing and banking in anticipation of future
correlative studies in this patient population.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP I: Participants receive olaparib orally (PO) twice daily (BID) the day before standard
radiation therapy (RT) commences (Day 0) and throughout the RT course until the last day of
RT administration. Olaparib is also continued on weekends (routine days without RT)
throughout the RT course. Participants undergo radiation therapy 5 days per week for 6 weeks
in the absence of disease progression or unaccepted toxicity.
GROUP II: Participants undergo standard radiation therapy 5 days per week for 6 weeks in the
absence of disease progression or unaccepted toxicity.
After completion of study treatment, participants are followed up within 5 weeks, then every
3 months until 3 years after registration, and then every 6 months for up to 8 years after
registration.
I. To compare the Invasive Disease-Free Survival (IDFS) of patients with inflammatory breast
cancer receiving concurrent administration of olaparib with standard doses of radiotherapy to
the chest wall and regional lymph nodes compared to standard doses of radiotherapy alone to
the chest wall and regional lymph nodes.
SECONDARY OBJECTIVES:
I. To compare the effect of concurrent administration of olaparib with radiotherapy versus
radiotherapy alone on improvement in locoregional control (measured by Locoregional
Recurrence-Free Interval), Distant Relapse-Free Survival, and Overall Survival in
inflammatory breast cancer patients.
ADDITIONAL OBJECTIVES:
I. To collect tissue and whole blood for processing and banking in anticipation of future
correlative studies in this patient population.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP I: Participants receive olaparib orally (PO) twice daily (BID) the day before standard
radiation therapy (RT) commences (Day 0) and throughout the RT course until the last day of
RT administration. Olaparib is also continued on weekends (routine days without RT)
throughout the RT course. Participants undergo radiation therapy 5 days per week for 6 weeks
in the absence of disease progression or unaccepted toxicity.
GROUP II: Participants undergo standard radiation therapy 5 days per week for 6 weeks in the
absence of disease progression or unaccepted toxicity.
After completion of study treatment, participants are followed up within 5 weeks, then every
3 months until 3 years after registration, and then every 6 months for up to 8 years after
registration.
Inclusion Criteria:
- Patients must have inflammatory breast cancer without distant metastases. All
biomarker subtype groups (estrogen receptor [ER], progesterone receptor [PR], HER2)
are eligible. Inflammatory disease will be defined per American Joint Committee on
Cancer (AJCC) 8th edition with documentation by history/exam and pathology at the time
of diagnosis.
- All patients must have completed neoadjuvant chemotherapy prior to mastectomy. The
chemotherapy regimen is at the discretion of the treating physician but it is
recommended that it include at least 4 cycles of anthracycline and/or taxane-based
therapy (plus targeted therapy for patients with HER2+ disease). Response to
chemotherapy is not a criterion for eligibility (both complete responders and those
with residual disease are eligible). Please note that although pathologic complete
response (pCR) is not required or excluded, pCR status must be determined post-surgery
prior to randomization.
- All patients must have undergone modified radical mastectomy (with negative margins on
ink) with pathologic nodal evaluation (from level I and II axillary lymph node
dissection) at least 3 weeks and no more than 12 weeks prior to randomization, unless
they receive additional chemotherapy after mastectomy. Patients must not have gross
residual tumor or positive microscopic margins after mastectomy.
- Additional adjuvant chemotherapy after surgery is allowed at the discretion of the
treating physician, either completed prior to randomization or planned for after
completion of protocol treatment. If adjuvant chemotherapy is administered after
mastectomy, the patient must be randomized at least 3 weeks but no more than 12 weeks
after the last dose of adjuvant chemotherapy.
- Patients must not have a history of radiation therapy to the ipsilateral chest wall
and/or regional nodes. Prior radiation therapy to other body sites is allowed.
- Patients must not be planning to receive any other investigational agents during
radiation therapy. Prior therapy, including prior treatment with olaparib or other
PARP inhibitor, is allowed.
- Patients must not have a known hypersensitivity to olaparib or any of the excipients
of the product.
- Patients must not have unresolved or unstable grade 3 or greater toxicity from prior
administration of another investigational drug and/or prior anti-cancer treatment.
- Patients must not be planning to receive strong or moderate CYP3A inhibitors or
inducers while on olaparib treatment. Patients receiving strong or moderate CYP3A
inhibitors must agree to discontinue use at least 2 weeks prior to receiving olaparib.
Patients receiving strong or moderate CYP3A inducers must agree to discontinue use at
least 5 weeks prior to receiving olaparib.
- Patients must not be planning to receive live virus or live bacterial vaccines while
receiving olaparib and during the 30 day follow up period
- Patients must not be planning to receive any additional anti-cancer therapy
(chemotherapy, endocrine therapy, immunotherapy, biological therapy or other novel
agent) while receiving radiotherapy with or without study medication. If a patient is
receiving concurrent anti-HER2 targeted therapies, they must not take these
medications during the period of radiotherapy (with or without study drug) while
enrolled on the study.
- Patients must have Zubrod performance status 0-2.
- Absolute neutrophil count (ANC) >= 1000/mm^3 (within 28 days prior to registration)
- Platelet count >= 100,000/mm^3 (within 28 days prior to registration)
- Hemoglobin >= 9.0 g/dL (after transfusion if required and within 28 days prior to
registration)
- Patients must have adequate renal function as evidenced by calculated creatinine
clearance >= 51 mL/min by Cockcroft-Gault equation, within 28 days prior to
registration. Calculated creatinine clearance = [(140 - age) x wt (kg) x 0.85 (if
female)]/[72 x creatinine (mg/dl)].
- Total bilirubin =< 1.5 x upper limit of normal (ULN) (within 28 days prior to
registration)
- Patients with documented Gilbert's disease may have bilirubin up to 2.5 mg/dL
- Serum glutamic-oxaloacetic transaminase (SGOT) =< 2.5 x ULN (within 28 days prior to
registration)
- Serum glutamate pyruvate transaminase (SGPT) =< 2.5 x ULN (within 28 days prior to
registration)
- Alkaline phosphatase =< 2.5 x ULN (within 28 days prior to registration)
- Patients must not have a history of other prior malignancy except for the following:
adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer,
adequately treated stage I or II cancer from which the patient is currently in
complete remission, or any other cancer from which the patient has been disease free
for five years
- Female patients must be postmenopausal or have a negative urine or serum pregnancy
test within 28 days prior to registration. Female patients of childbearing potential
and male patients with partners of childbearing potential, who are sexually active,
must agree to the use of two highly effective forms of contraception.
- Patients who are breastfeeding must agree to discontinue breastfeeding before
receiving olaparib due to potential risk for adverse events in nursing infants
secondary to treatment of the mother with olaparib.
- Patients must not have active uncontrolled infection, symptomatic congestive heart
failure, unstable angina pectoris or cardiac arrhythmia.
- Patients must be able to swallow and retain oral medications and have no known
gastrointestinal disorders likely to interfere with absorption of the study
medication.
- Patients must not have a history of a resting electrocardiography (ECG) indicating
uncontrolled, potentially reversible cardiac conditions (such as unstable ischemia,
uncontrolled symptomatic arrhythmia, congestive heart failure, Fridericia's formula
corrected QT interval [QTcF] prolongation > 500 ms, electrolyte disturbances) or
congenital long QCYP3T syndrome.
- Patients must not have myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or
with features suggestive of MDS/AML.
- Patient must not have had major surgery within 2 weeks of starting study treatments
and patients must have recovered from any effects of any major surgery.
- Patients must not have a history of uncontrolled ventricular arrhythmia, recent
(within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable
spinal cord compression, superior vena cava syndrome, or extensive interstitial
bilateral lung disease on high resolution computed tomography (HRCT) scan.
- Patients must not have had previous allogenic bone marrow transplant or double
umbilical cord blood transplantation (dUCBT).
- Patients must not have had whole blood transfusions in the last 120 days prior to
randomization.
We found this trial at
62
sites
Seneca, South Carolina 29672
Principal Investigator: Michael D. Zurenko
Phone: 864-241-6251
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
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...
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666 Elm Street
Buffalo, New York 14263
Buffalo, New York 14263
(716) 845-2300
Principal Investigator: Simon D. Fung-Kee-Fung
Phone: 800-767-9355
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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60 Crittenden Blvd # 70
Rochester, New York 14642
Rochester, New York 14642
(585) 275-2121
Principal Investigator: Paul M. Barr
Phone: 585-275-5830
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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2226 Liliha Street
'Aiea, Hawaii 96701
'Aiea, Hawaii 96701
Principal Investigator: Jami A. Fukui
Phone: 808-678-9000
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4650 Jefferson Lane Northeast
Albuquerque, New Mexico 87109
Albuquerque, New Mexico 87109
Principal Investigator: Gregory N. Gan
Phone: 505-272-0530
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Albuquerque, New Mexico 87102
Principal Investigator: Gregory N. Gan
Phone: 505-272-0530
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Ames, Iowa 50010
Principal Investigator: Joseph J. Merchant
Phone: 515-956-4132
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Asheville, North Carolina 28801
Principal Investigator: Christopher H. Chay
Phone: 828-213-4150
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Asheville, North Carolina 28816
Principal Investigator: Christopher H. Chay
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Bemidji, Minnesota 56601
Principal Investigator: Preston D. Steen
Phone: 218-333-5000
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300 N. Seventh St.
Bismarck, North Dakota 58501
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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915 Highland Blvd
Bozeman, Montana 59715
Bozeman, Montana 59715
(406) 414-5000
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
Bozeman Deaconess Hospital Bozeman Deaconess Hospital is a Joint Commission certified, licensed Level III trauma...
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Brewer, Maine 04412
Principal Investigator: Thomas H. Openshaw
Phone: 800-987-3005
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Chadds Ford, Pennsylvania 19317
Principal Investigator: Gregory A. Masters
Phone: 302-623-4450
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303 East Superior Street
Chicago, Illinois 60611
Chicago, Illinois 60611
Principal Investigator: Eric D. Donnelly
Phone: 312-695-1301
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Columbus, Ohio 43210
Principal Investigator: Sachin Jhawar
Phone: 800-293-5066
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1200 Pleasant St
Des Moines, Iowa 50309
Des Moines, Iowa 50309
(515) 241-6212
Principal Investigator: Robert J. Behrens
Phone: 515-241-6727
Iowa Methodist Medical Center Iowa Methodist Medical Center was established in 1901 in a single...
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Eau Claire, Wisconsin 54701
Principal Investigator: John Simmons
Phone: 800-782-8581
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Fargo, North Dakota 58122
Principal Investigator: Preston D. Steen
Phone: 701-234-6161
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Fishers, Indiana 46037
Principal Investigator: Richard C. Zellars
Phone: 317-356-2422
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1117 29th St S
Great Falls, Montana 59405
Great Falls, Montana 59405
(406) 771-7300
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
Benefis Healthcare- Sletten Cancer Institute Benefis Hospitals has 516 beds at its two campuses (that...
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Greenville, South Carolina 29605
Principal Investigator: Michael D. Zurenko
Phone: 864-241-6251
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Greenville, South Carolina 29615
Principal Investigator: Michael D. Zurenko
Phone: 864-241-6251
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Greer, South Carolina 29650
Principal Investigator: Michael D. Zurenko
Phone: 864-241-6251
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Honolulu, Hawaii 96817
Principal Investigator: Jami A. Fukui
Phone: 808-547-6881
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1301 Punchbowl St
Honolulu, Hawaii 96813
Honolulu, Hawaii 96813
(808) 538-9011
Principal Investigator: Jami A. Fukui
Queen's Medical Center The Queen's Medical Center, located in downtown Honolulu, Hawaii, is a private,...
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Honolulu, Hawaii 96813
Principal Investigator: Jami A. Fukui
Phone: 808-524-6115
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Houston, Texas 77030
Principal Investigator: Wendy A. Woodward
Phone: 877-312-3961
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Indianapolis, Indiana 46202
Principal Investigator: Richard C. Zellars
Phone: 317-278-5632
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535 Barnhill Dr
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
(888) 600-4822
Principal Investigator: Richard C. Zellars
Phone: 317-278-5632
Indiana University Melvin and Bren Simon Cancer Center At the IU Simon Cancer Center, more...
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Jonesboro, Arkansas 72401
Principal Investigator: Philip E. Lammers
Phone: 870-936-7067
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Kansas City, Kansas 66160
Principal Investigator: Priyanka Sharma
Phone: 913-945-7552
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Kansas City, Missouri 64154
Principal Investigator: Priyanka Sharma
Phone: 913-945-7552
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Lawton, Oklahoma 73505
Principal Investigator: Sobia Nabeel
Phone: 877-231-4440
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Lee's Summit, Missouri 64064
Principal Investigator: Priyanka Sharma
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Marshfield, Wisconsin 54449
Principal Investigator: John Simmons
Phone: 800-782-8581
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Memphis, Tennessee 38120
Principal Investigator: Philip E. Lammers
Phone: 901-226-1366
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9601 Townline Rd
Minocqua, Wisconsin 54548
Minocqua, Wisconsin 54548
(715) 358-1000
Principal Investigator: John Simmons
Phone: 800-782-8581
Marshfield Clinic Minocqua Center The Clinic was incorporated under Wisconsin law in 1916 and operates...
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Newark, Delaware 19713
Principal Investigator: Gregory A. Masters
Phone: 302-623-4450
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Newark, Delaware 19713
Principal Investigator: Gregory A. Masters
Phone: 302-623-4450
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Novi, Michigan 48374
Principal Investigator: Cynthia M. Vakhariya
Phone: 248-849-5332
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940 NE 13th St
Oklahoma City, Oklahoma 73190
Oklahoma City, Oklahoma 73190
(405) 271-6458
Principal Investigator: Sobia Nabeel
Phone: 405-271-8777
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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8303 Dodge Street
Omaha, Nebraska 68114
Omaha, Nebraska 68114
(402) 354–4000
Principal Investigator: Kirsten M. Leu
Phone: 402-354-5144
Nebraska Methodist Hospital Methodist Hospital is a general medical and surgical hospital in Omaha, NE....
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Overland Park, Kansas 66210
Principal Investigator: Priyanka Sharma
Phone: 913-945-7552
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1100 Belk Boulevard
Oxford, Mississippi 38655
Oxford, Mississippi 38655
Principal Investigator: Philip E. Lammers
Phone: 901-226-1366
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Pensacola, Florida 32504
Principal Investigator: James F. Watkins
Phone: 850-416-4611
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Portland, Oregon 97225
Principal Investigator: Gary E. Goodman
Phone: 503-215-2614
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Rehoboth Beach, Delaware 19971
Principal Investigator: Gregory A. Masters
Phone: 302-645-3100
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Rice Lake, Wisconsin 54868
Principal Investigator: John Simmons
Phone: 800-782-8581
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640 Jackson Street
Saint Paul, Minnesota 55101
Saint Paul, Minnesota 55101
651-254-3456
Principal Investigator: David M. King
Phone: 952-993-1517
Regions Hospital Established in 1872, Regions Hospital is a private, not-for-profit organization. The hospital provides...
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2000 Circle of Hope Dr
Salt Lake City, Utah 84112
Salt Lake City, Utah 84112
(801) 585-0303
Principal Investigator: Kristine E. Kokeny
Phone: 888-424-2100
Huntsman Cancer Institute at University of Utah Huntsman Cancer Institute (HCI) is part of the...
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Savannah, Georgia 31405
Principal Investigator: Howard A. Zaren
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Seaford, Delaware 19973
Principal Investigator: Gregory A. Masters
Phone: 302-645-3100
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1305 W 18th St
Sioux Falls, South Dakota 57117
Sioux Falls, South Dakota 57117
(605) 333-1000
Principal Investigator: Preston D. Steen
Phone: 605-312-3320
Sanford USD Medical Center - Sioux Falls Sanford
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Southfield, Michigan 48075
Principal Investigator: Cynthia M. Vakhariya
Phone: 248-849-5337
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7601 Southcrest Parkway
Southhaven, Mississippi 38671
Southhaven, Mississippi 38671
Principal Investigator: Philip E. Lammers
Phone: 901-226-1366
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Spartanburg, South Carolina 29307
Principal Investigator: Michael D. Zurenko
Phone: 864-241-6251
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4100 Wisconsin 66
Stevens Point, Wisconsin 54482
Stevens Point, Wisconsin 54482
Principal Investigator: John Simmons
Phone: 800-782-8581
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602 W University Ave
Urbana, Illinois 61801
Urbana, Illinois 61801
(217) 383-3010
Principal Investigator: Kalika P. Sarma
Phone: 800-446-5532
Carle Cancer Center Carle Cancer Center delivers comprehensive care through leading-edge technology and advanced research,...
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3401 Cranberry Blvd
Weston, Wisconsin 54476
Weston, Wisconsin 54476
(715) 393-2100
Principal Investigator: John Simmons
Phone: 888-799-3989
Diagnostic and Treatment Center At The Diagnostic & Treatment Center, the patient is at the...
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Westwood, Kansas 66205
Principal Investigator: Priyanka Sharma
Phone: 913-945-7552
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