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BRIEF TITLE: Trial of Concurrent Chemoradiotherapy With or Without Atezolizumab in Localized Muscle Invasive Bladder Cancer (Study SWOG/NRG 1806)

Phase III Randomized Trial of Concurrent Chemoradiotherapy With or Without Atezolizumab in Localized Muscle Invasive Bladder Cancer


  • Org Study ID: NCI-2018-03264
  • Secondary ID: NCI-2018-03264,S1806,S1806,U10CA180888
  • NCT ID: NCT03775265
  • NCT Alias:
  • Sponsor: National Cancer Institute (NCI) - NIH
  • Source: National Cancer Institute (NCI)

Brief Summary

This phase III trial studies how well chemotherapy and radiation therapy work with or without atezolizumab in treating patients with localized muscle invasive bladder cancer. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as gemcitabine, cisplatin, fluorouracil and mitomycin-C, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with radiation therapy may kill more tumor cells. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving atezolizumab with radiation therapy and chemotherapy may work better in treating patients with localized muscle invasive bladder cancer compared to radiation therapy and chemotherapy without atezolizumab.

Detailed Description


PRIMARY OBJECTIVE:

I. To compare bladder intact event-free survival (BI-EFS) for concurrent chemoradiation
therapy (CRT) with and without atezolizumab in localized muscle invasive bladder cancer
(MIBC).

SECONDARY OBJECTIVES:

I. To compare overall survival between the two arms. II. To compare modified bladder intact
event-free survival including cancer related death between arms.

III. To compare complete and partial pathologic response between arms at 3 months after
completing chemoradiation therapy.

IV. To estimate metastases-free survival by arm. V. To compare the qualitative and
quantitative adverse events from each arm. VI. To estimate the rate of non-muscle invasive
bladder cancer recurrence by arm.

VII. To estimate the rate of salvage cystectomy and reasons for cystectomy by arm.

VIII. To compare mean patient-reported global quality of life (QOL) at week 54 using the
European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire
(QLQ)-Core (C)30 Global Health Status (GHS) subscale score between patients with localized
muscle-invasive bladder cancer randomized to chemoradiation with versus (vs.) without
atezolizumab.

TRANSLATIONAL MEDICINE OBJECTIVES:

I. To test the hypothesis that a panel of validated biomarkers of concurrent CRT involving
nuclear MRE11, impaired deoxyribonucleic acid damage response (DDR) function and tumor
subtyping will be prognostic for BI-EFS among patients receiving either concurrent CRT or
chemoimmuno-radiotherapy (CIRT) of the primary tumor.

II. To test the hypothesis that tumor total mutation burden, neoantigen burden, infiltrating
immune response, PD-L1 expression and T cell response are associated with augmented response
after concurrent CIRT.

III. To bank urine specimens for future use.

PATIENT-REPORTED OUTCOMES (PROs) OBJECTIVES:

I. To compare mean patient-reported global QOL as measured by the EORTC QLQ-C30 Global Health
Status subscale scores at week 54 between patients with localized muscle-invasive bladder
cancer randomized to chemoradiation with versus without atezolizumab. (Primary) II. To
compare mean patient-reported bowel symptoms at each assessment time by arm using the Bowel
Domain of the Expanded Prostate Index (EPIC- 26) short form, the bladder-specific supplement
to the QLQ-C30, the EORTC QLQ-Muscle Invasive Bladder Cancer (BLM30), the Physical
Functioning subscale of the EORTC QLQ-C30, and overall health status using the EuroQol Five
Dimension Five Level Scale (EQ-5D-5L). (Exploratory) III. To compare longitudinal change over
time by arm in patient-reported global QOL using the EORTC QLQ-C30, the Bowel Domain of the
Expanded Prostate Index (EPIC-26) short form, the bladder-specific supplement to the QLQ-C30,
the EORTC QLQ-BLM30, the Physical Functioning subscale of the EORTC QLQ-C30, and overall
health status using the EQ-5D-5L. (Exploratory)

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo radiation therapy (RT) (3 dimensional [D] CRT or intensity-modulated
radiation therapy [IMRT]) Monday-Friday for up to 7 weeks. Patients also receive chemotherapy
based on physician's choice of gemcitabine intravenously (IV) twice weekly for 6 weeks, or
cisplatin IV weekly for 6 weeks concurrent with RT, or fluorouracil IV on same days as doses
1-5 and 16-20 of radiation therapy, and mitomycin IV on day 1 of radiation therapy in the
absence of disease progression or unacceptable toxicity.

ARM II: Patients undergo RT (3DCRT or IMRT) Monday-Friday for up to 7 weeks and receive
chemotherapy based on physician's choice as in Arm I. Patients also receive atezolizumab IV
over 60 minutes on day 1 of chemotherapy. Treatment repeats every 21 days for a total of 6
months (9 doses total) in the absence of disease progression or unacceptable toxicity.

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

Overal Status Start Date Phase Study Type
Recruiting April 19, 2019 Phase 3 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Bladder intact event-free survival (BI-EFS)

Primary Outcome 1 - Time Frame: From the date of randomization to the first documentation of a BI-EFS event, assessed up to 5 years

Condition:

  • Bladder Carcinoma Infiltrating the Muscle of the Bladder Wall
  • Bladder Urothelial Carcinoma
  • Stage II Bladder Cancer AJCC v8
  • Stage III Bladder Cancer AJCC v8
  • Stage IIIA Bladder Cancer AJCC v8

Eligibility

Criteria:
Inclusion Criteria:

- STEP 1 REGISTRATION:

- If this will be the first patient from a registering site to receive a given RT
modality (3DCRT vs. IMRT), the site must first submit pre-RT planning documents within
3 days of Step 1 registration and receive approval from Imaging and Radiation Oncology
Core (IROC) before randomizing the patient to Step 2. If this will not be the first
patient to receive a specific RT modality, the patient should be immediately
randomized to Step 2 on the same day.

- STEP 2 RANDOMIZATION

- If patient required review of pre-RT planning, randomization must occur within 14 days
of initial registration.

- Patients must have histologically proven, T2-T4a N0M0 urothelial carcinoma of the
bladder within 120 days prior to randomization and no intervening treatment between
the histologic proof and randomization. Patients with mixed urothelial carcinoma will
be eligible for the trial, but the presence of small cell carcinoma will make a
patient ineligible. Patients with lymph nodes >= 1.0 cm in shortest cross-sectional
diameter on imaging (computed tomography [CT]/magnetic resonance imaging [MRI] of
abdomen and pelvis) must have a biopsy of the enlarged lymph node showing no tumor
involvement within 70 days prior to randomization. These patients may be suitable for
neoadjuvant chemotherapy and radical cystectomy and are eligible for this trial if
they seek out a bladder sparing treatment strategy, however patients who have received
prior systemic chemotherapy for bladder cancer are not eligible for the trial.

- Patients must undergo a transurethral resection of bladder tumor (TURBT) within 70
days prior to randomization. In a situation where a patient is referred from outside
to the enrolling institution, patient must have a repeat cystoscopy by the urologist
who will be following the patient on the clinical trial to assess the adequacy of the
prior TURBT. Patient may then undergo repeat TURBT if deemed necessary as standard of
care by the treating urologist. Patients may have either completely or partially
resected tumors as long as the treating urologist attempted maximal resection. Patient
must not have T4b disease.

- Patients must undergo radiological staging within 70 days prior to randomization.
Imaging of chest, abdomen, and pelvis must be performed using CT or MRI. Patients must
not have evidence of T4bN1-3 disease. Eligibility is based on the local radiology
report.

- Patients with hydronephrosis are eligible if they have unilateral hydronephrosis and
kidney function meets criteria specified.

- Patient must be planning to receive one of the protocol specified chemotherapy
regimens.

- All adverse events associated with any prior surgery and intravesical therapy must
have resolved to Common Terminology Criteria for Adverse Events (CTCAE) grade =< 2
prior to randomization.

- Patient may or may not be radical cystectomy candidates.

- Absolute neutrophil count (ANC) >=1,500/microliter (mcL) (within 28 days prior to
randomization).

- Platelets >= 100,000/mcL (within 28 days prior to randomization).

- Hemoglobin >= 9 g/dL (within 28 days prior to randomization).

- Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (except patients
with Gilbert's syndrome, who must have a total bilirubin < 3.0 mg/dL) (within 28 days
prior to randomization).

- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2.5 x IULN
(within 28 days prior to randomization).

- Patients must have adequate renal function as evidenced by calculated creatinine
clearance >= 25 mL/min. The creatinine used to calculate the clearance result must
have been obtained within 28 days prior to randomization.

- Patients must have Zubrod performance status =< 2.

- Patients must have a baseline electrocardiography (ECG) performed within 30 days prior
to randomization.

- If patient has a known history of hepatitis B virus (HBV) or hepatitis C virus (HCV),
they must meet the following criteria within 28 days prior to randomization.

- Patients with past or resolved hepatitis B infection (defined as having a
negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc
[antibody to hepatitis B core antigen] antibody test) are eligible.

- Patients positive for hepatitis C virus (HCV) antibody are eligible only if
polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA).

- Patients who are known to be positive for human immunodeficiency virus (HIV) are
eligible only if they have all of the following:

- A stable regimen of highly active anti-retroviral therapy (HAART)

- No requirement for concurrent antibiotics or antifungal agents for the prevention
of opportunistic infections

- A CD4 count above 250 cells/mcL and an undetectable HIV viral load on standard
PCR-based tests within 28 days prior to randomization.

- No other prior malignancy is allowed 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 two years. Patients with
localized prostate cancer who are being followed by an active surveillance program are
also eligible.

- Female patients of childbearing potential must have a serum pregnancy test prior to
randomization. Patients must not be pregnant or nursing due to the potential
teratogenic side effects of the protocol treatment. Women of child-bearing potential
and men must agree to use adequate contraception (hormonal or barrier method of birth
control; abstinence) prior to study entry, for the duration of protocol treatment, and
for 5 months (150 days) after the last dose of all study drugs. A woman is considered
to be of reproductive potential" if she has had a menses at any time in the preceding
12 consecutive months.

- Patients must be offered the opportunity to participate in specimen banking for future
studies.

- Patients who can complete Patient-Reported Outcome instruments in English or Spanish
must agree to complete the EORTC QLQ-C30, the EORTC QLQ-BLM30, the EPIC-26 (bowel
domain only), and the EQ-5D-5L per protocol schedule of assessment.

- As a part of the Oncology Patient Enrollment Network (OPEN) registration process the
treating institution's identity is provided in order to ensure that the current
(within 365 days) date of institutional review board approval for this study has been
entered in the system.

Exclusion Criteria:

- STEP 2 RANDOMIZATION EXCLUSION CRITERIA

- Patients must not have had urothelial carcinoma or histological variant at any site
outside of the urinary bladder within the previous 24 months except Ta/T1/carcinoma in
situ (CIS) of the upper urinary tract including renal pelvis and ureter if the patient
had undergone complete nephroureterectomy.

- Patients must not have diffuse CIS based on cystoscopy and biopsy.

- Patient must not have received any systemic chemotherapy for their bladder cancer.

- Patient must not have had prior pelvic radiation.

- Patients must not have received prior treatment for muscle invasive bladder cancer
including neoadjuvant chemotherapy for the current tumor.

- Patients must not have received any systemic therapy (including, but not limited to,
interferon alfa-2b, high dose IL-2, pegylated interferon [PEG-IFN], anti-PD-1,
anti-PD-L1), for non-muscle invasive bladder cancer. Prior intravesical BCG,
interferon, and intravesical chemotherapy are allowed.

- Patients must not have received any of the following prohibited therapies within 28
days prior to randomization or be planning to receive any of the following prohibited
therapies during protocol treatment:

- Anti-cancer systemic chemotherapy or biological therapy not specified in the
protocol.

- Immunotherapy not specified in this protocol.

- Systemic or intravesical use of any non-study anti-cancer agent (investigational
or non-investigational).

- Investigational agents other than atezolizumab.

- Live vaccines: Examples of live vaccines include, but are not limited to, the
following: measles, mumps, rubella, chicken pox, shingles, yellow fever, rabies,
bacillus Calmette-Guerin (BCG), and typhoid (oral) vaccine. Seasonal influenza
vaccines for injection are generally killed virus vaccines and are allowed;
however, intranasal influenza vaccines (e.g. Flu-Mist) are live attenuated
vaccines, and are not allowed. Prior administration of intravesical BCG is
allowed.

- Glucocorticoids for any purpose other than to modulate symptoms from an event of
suspected immunologic etiology. The use of physiologic doses of corticosteroids
(defined as 10 mg prednisone) are acceptable, however site investigators should
consult with the study chair for any dose higher than 10 mg prednisone.
Dexamethasone 4 mg iv with chemotherapy to prevent nausea is allowed.

- RANKL infusion: Concurrent denosumab (which binds the cytokine RANKL) for any
known indication is prohibited due to interaction with study medication.

- Patients must not have a major surgical procedure within 28 days prior to
randomization. If patient had any surgical procedure then they should have recovered
to full presurgical performance status and surgical adverse events should have
resolved to grade =< 2. TURBT is not considered a major surgical procedure.

- Patients must not have received treatment with systemic immunosuppressive medications
(including, but not limited to, prednisone, cyclophosphamide, azathioprine,
methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 14
days prior to randomization. Exceptions:

- Patients may have received acute, low dose, systemic immunosuppressant
medications (e.g., a one-time dose of dexamethasone for nausea).

- The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone)
for patients with orthostatic hypotension or adrenocortical insufficiency is
allowed. Physiological doses equivalent of 10 mg prednisone daily are allowed.
Short term steroids given as antiemetic therapy, e.g. 4 mg dexamethasone or
equivalent once a week, is allowed.

- Patients must not have received a live, attenuated vaccine within 4 weeks prior to
randomization or anticipate that such a live, attenuated vaccine will be required
while on protocol treatment and up to 5 months after the last dose of protocol
treatment.

- Inactivated influenza vaccination should be given during influenza season only
(approximately October to March). Patients must not receive live, attenuated
influenza vaccine within 4 weeks prior to randomization or while on protocol
treatment and up to 5 months after the last dose of protocol treatment.

- Patients must not have undergone prior allogeneic bone marrow transplantation or prior
solid organ transplantation.

- Patients must not have clinically significant liver disease that precludes patient
from treatment regimens prescribed on the study (including, but not limited to, active
viral, alcoholic or other autoimmune hepatitis, cirrhosis or inherited liver disease).

- Patient must not have history of idiopathic pulmonary fibrosis, pneumonitis (including
drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic
organizing pneumonia, etc.), or evidence of active pneumonitis.

- Patients must not have an active infection requiring oral or IV antibiotics within 14
days prior to randomization. Patients receiving prophylactic antibiotics (e.g., for
prevention of a urinary tract infection or chronic obstructive pulmonary disease) are
not eligible. If patient develops urinary tract infection after TURBT they must have
recovered from the infection prior to registration.

- Patients must not have active autoimmune disease that has required systemic treatment
in past two years (i.e., with use of disease modifying agents, corticosteroids or
immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or
physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency,
etc.) is not considered a form of systemic treatment. Autoimmune diseases include, but
are not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory
bowel disease, vascular thrombosis associated with antiphospholipid syndrome,
Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome,
multiple sclerosis, autoimmune thyroid disease, vasculitis, Graves' disease treated
with methimazole or glomerulonephritis.

- Patient must not have a history of active tuberculosis.

- Patients must not be known to be allergic to Chinese hamster egg or ovary cell
products and must not have any known major allergic reactions to any study drug.
Show More

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Parminder Singh

Role: Principal Investigator

Affiliation: Southwest Oncology Group

Locations

Facility Status Contact
Mayo Clinic Hospital in Arizona
Phoenix, Arizona 85054
United States
Recruiting Site Public Contact
855-776-0015
Mayo Clinic in Arizona
Scottsdale, Arizona 85259
United States
Recruiting Site Public Contact
855-776-0015
Banner University Medical Center - Tucson
Tucson, Arizona 85719
United States
Recruiting Site Public Contact

aselegue@email.arizona.edu
University of Arizona Cancer Center-North Campus
Tucson, Arizona 85719
United States
Recruiting Site Public Contact
800-327-2873
UC San Diego Moores Cancer Center
La Jolla, California 92093
United States
Recruiting Site Public Contact
858-822-5354
cancercto@ucsd.edu
Los Angeles County-USC Medical Center
Los Angeles, California 90033
United States
Recruiting Site Public Contact
323-865-0451
USC / Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
Recruiting Site Public Contact
323-865-0451
Cedars Sinai Medical Center
Los Angeles, California 90048
United States
Recruiting Site Public Contact
310-423-8965
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California 92868
United States
Recruiting Site Public Contact
877-827-8839
ucstudy@uci.edu
University of California Davis Comprehensive Cancer Center
Sacramento, California 95817
United States
Recruiting Site Public Contact
916-734-3089
Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo, California 93401
United States
Recruiting Site Public Contact

Diane.DeVos-Schmidt@DignityHealth.org
University of Colorado Hospital
Aurora, Colorado 80045
United States
Recruiting Site Public Contact
720-848-0650
UCHealth Memorial Hospital Central
Colorado Springs, Colorado 80909
United States
Recruiting Site Public Contact
719-365-2406
Memorial Hospital North
Colorado Springs, Colorado 80920
United States
Recruiting Site Public Contact
719-364-6700
Shaw Cancer Center
Edwards, Colorado 81632
United States
Suspended
Poudre Valley Hospital
Fort Collins, Colorado 80524
United States
Recruiting Site Public Contact
970-297-6150
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado 80528
United States
Recruiting Site Public Contact

protocols@swog.org
UCHealth Greeley Hospital
Greeley, Colorado 80631
United States
Recruiting Site Public Contact

protocols@swog.org
Medical Center of the Rockies
Loveland, Colorado 80538
United States
Recruiting Site Public Contact
970-203-7083
Yale University
New Haven, Connecticut 06520
United States
Recruiting Site Public Contact
203-785-5702
canceranswers@yale.edu
Helen F Graham Cancer Center
Newark, Delaware 19713
United States
Recruiting Site Public Contact
302-623-4450
mhayden@christianacare.org
Medical Oncology Hematology Consultants PA
Newark, Delaware 19713
United States
Recruiting Site Public Contact
302-623-4450
mhayden@christianacare.org
Sibley Memorial Hospital
Washington, District of Columbia 20016
United States
Recruiting Site Public Contact
202-243-2373
jquiver1@jhmi.edu
Mount Sinai Comprehensive Cancer Center at Aventura
Aventura, Florida 33180
United States
Recruiting Site Public Contact
305-674-2625
yenrique@msmc.com
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida 33146
United States
Recruiting Site Public Contact
305-243-2647
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida 33442
United States
Recruiting Site Public Contact
305-243-2647
University of Florida Health Science Center - Gainesville
Gainesville, Florida 32610
United States
Active, not recruiting
Mount Sinai Medical Center
Miami Beach, Florida 33140
United States
Recruiting Site Public Contact
305-674-2625
yenrique@msmc.com
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida 33136
United States
Recruiting Site Public Contact
305-243-2647
Moffitt Cancer Center
Tampa, Florida 33612
United States
Recruiting Site Public Contact
800-679-0775
canceranswers@moffitt.org
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
United States
Recruiting Site Public Contact
404-778-1868
Emory Saint Joseph's Hospital
Atlanta, Georgia 30342
United States
Recruiting Site Public Contact
404-851-7115
CTCA at Southeastern Regional Medical Center
Newnan, Georgia 30265
United States
Recruiting Site Public Contact
770-400-6629
Pali Momi Medical Center
'Aiea, Hawaii 96701
United States
Recruiting Site Public Contact
808-486-6000
The Cancer Center of Hawaii-Pali Momi
'Aiea, Hawaii 96701
United States
Recruiting Site Public Contact
808-678-9000
Hawaii Cancer Care Inc-POB II
Honolulu, Hawaii 96813
United States
Recruiting Site Public Contact
808-524-6115
Queen's Medical Center
Honolulu, Hawaii 96813
United States
Recruiting Site Public Contact
808-545-8548
Queen's Cancer Center - Kuakini
Honolulu, Hawaii 96817
United States
Recruiting Site Public Contact
808-531-8521
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii 96817
United States
Recruiting Site Public Contact
808-547-6881
Illinois CancerCare-Bloomington
Bloomington, Illinois 61704
United States
Recruiting Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com
Illinois CancerCare-Canton
Canton, Illinois 61520
United States
Recruiting Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com
Illinois CancerCare-Carthage
Carthage, Illinois 62321
United States
Recruiting Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com
Northwestern University
Chicago, Illinois 60611
United States
Recruiting Site Public Contact
312-695-1301
cancer@northwestern.edu
Rush University Medical Center
Chicago, Illinois 60612
United States
Recruiting Site Public Contact
312-942-5498
clinical_trials@rush.edu
Decatur Memorial Hospital
Decatur, Illinois 62526
United States
Recruiting Site Public Contact
217-876-4740
rhamrick@dmhhs.org
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois 60115
United States
Recruiting Site Public Contact
630-352-5360
Donald.Smith3@nm.org
Crossroads Cancer Center
Effingham, Illinois 62401
United States
Recruiting Site Public Contact
217-876-4740
rhamrick@dmhhs.org
Illinois CancerCare-Eureka
Eureka, Illinois 61530
United States
Recruiting Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com
Illinois CancerCare-Galesburg
Galesburg, Illinois 61401
United States
Recruiting Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com
Western Illinois Cancer Treatment Center
Galesburg, Illinois 61401
United States
Recruiting Site Public Contact
309-344-2831
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois 60134
United States
Recruiting Site Public Contact
630-352-5360
Donald.Smith3@nm.org
Edward Hines Jr VA Hospital
Hines, Illinois 60141
United States
Recruiting Site Public Contact
708-202-8387
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois 61443
United States
Recruiting Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com
Illinois CancerCare-Macomb
Macomb, Illinois 61455
United States
Recruiting Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com
Loyola University Medical Center
Maywood, Illinois 60153
United States
Recruiting Site Public Contact
708-226-4357
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois 61350
United States
Recruiting Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com
Illinois CancerCare-Pekin
Pekin, Illinois 61554
United States
Recruiting Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com
Illinois CancerCare-Peoria
Peoria, Illinois 61615
United States
Recruiting Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com
Methodist Medical Center of Illinois
Peoria, Illinois 61636
United States
Recruiting Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com
Illinois CancerCare-Peru
Peru, Illinois 61354
United States
Recruiting Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com
Illinois CancerCare-Princeton
Princeton, Illinois 61356
United States
Recruiting Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com
Springfield Clinic
Springfield, Illinois 62702
United States
Suspended
Memorial Medical Center
Springfield, Illinois 62781
United States
Recruiting Site Public Contact
217-788-3528
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois 60555
United States
Recruiting Site Public Contact
630-352-5360
Donald.Smith3@nm.org
Reid Health
Richmond, Indiana 47374
United States
Recruiting Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org
Mary Greeley Medical Center
Ames, Iowa 50010
United States
Suspended
McFarland Clinic PC - Ames
Ames, Iowa 50010
United States
Recruiting Site Public Contact
515-239-4734
ksoder@mcfarlandclinic.com
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa 50325
United States
Recruiting Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org
Mercy Cancer Center-West Lakes
Clive, Iowa 50325
United States
Recruiting Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org
Greater Regional Medical Center
Creston, Iowa 50801
United States
Recruiting Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa 50314
United States
Recruiting Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org
Mercy Medical Center - Des Moines
Des Moines, Iowa 50314
United States
Recruiting Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org
Mercy Medical Center-West Lakes
West Des Moines, Iowa 50266
United States
Recruiting Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org
University of Kansas Cancer Center
Kansas City, Kansas 66160
United States
Recruiting Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas 66210
United States
Recruiting Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas 66205
United States
Recruiting Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu
Ascension Via Christi Hospitals Wichita
Wichita, Kansas 67214
United States
Recruiting Site Public Contact
800-362-0070
Keisha.humphries@ascension.org
University of Kentucky/Markey Cancer Center
Lexington, Kentucky 40536
United States
Recruiting Site Public Contact
859-257-3379
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky 40202
United States
Recruiting Site Public Contact
502-562-3429
East Jefferson General Hospital
Metairie, Louisiana 70006
United States
Recruiting Site Public Contact
504-210-3539
emede1@lsuhsc.edu
LSU Healthcare Network / Metairie Multi-Specialty Clinic
Metairie, Louisiana 70006
United States
Recruiting Site Public Contact
504-210-3539
emede1@lsuhsc.edu
MaineHealth Coastal Cancer Treatment Center
Bath, Maine 04530
United States
Suspended
Waldo County General Hospital
Belfast, Maine 04915
United States
Suspended
MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford
Biddeford, Maine 04005
United States
Suspended
Stephens Memorial Hospital
Norway, Maine 04268
United States
Suspended
Maine Medical Center-Bramhall Campus
Portland, Maine 04102
United States
Suspended
Penobscot Bay Medical Center
Rockport, Maine 04856
United States
Suspended
MaineHealth Cancer Care Center of York County
Sanford, Maine 04073
United States
Suspended
MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford
Sanford, Maine 04073
United States
Suspended
Maine Medical Center- Scarborough Campus
Scarborough, Maine 04074
United States
Recruiting Site Public Contact
207-396-8090
wrighd@mmc.org
Maine Medical Partners - South Portland
South Portland, Maine 04106
United States
Suspended
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland 21287
United States
Recruiting Site Public Contact
410-955-8804
jhcccro@jhmi.edu
Massachusetts General Hospital Cancer Center
Boston, Massachusetts 02114
United States
Recruiting Site Public Contact
877-726-5130
Saint Joseph Mercy Hospital
Ann Arbor, Michigan 48106
United States
Recruiting Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
Bronson Battle Creek
Battle Creek, Michigan 49017
United States
Recruiting Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org
Saint Joseph Mercy Brighton
Brighton, Michigan 48114
United States
Recruiting Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
Saint Joseph Mercy Canton
Canton, Michigan 48188
United States
Recruiting Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
Saint Joseph Mercy Chelsea
Chelsea, Michigan 48118
United States
Recruiting Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
21st Century Oncology MHP - Clarkston
Clarkston, Michigan 48346
United States
Recruiting Site Public Contact
248-338-0663
Beaumont Hospital - Dearborn
Dearborn, Michigan 48124
United States
Recruiting Site Public Contact
248-551-7695
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan 48201
United States
Recruiting Site Public Contact
313-576-9790
ctoadmin@karmanos.org
Henry Ford Hospital
Detroit, Michigan 48202
United States
Recruiting Site Public Contact
313-916-3721
CTOResearch@hfhs.org
21st Century Oncology MHP - Farmington
Farmington Hills, Michigan 48334
United States
Recruiting Site Public Contact
248-338-0663
Weisberg Cancer Treatment Center
Farmington Hills, Michigan 48334
United States
Recruiting Site Public Contact
313-576-9790
ctoadmin@karmanos.org
West Michigan Cancer Center
Kalamazoo, Michigan 49007
United States
Recruiting Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org
Sparrow Hospital
Lansing, Michigan 48912
United States
Recruiting Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
Saint Mary Mercy Hospital
Livonia, Michigan 48154
United States
Recruiting Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan 48073
United States
Recruiting Site Public Contact
248-551-7695
Ascension Saint Mary's Hospital
Saginaw, Michigan 48601
United States
Recruiting Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
Munson Medical Center
Traverse City, Michigan 49684
United States
Recruiting Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org
William Beaumont Hospital - Troy
Troy, Michigan 48085
United States
Recruiting Site Public Contact
248-551-7695
21st Century Oncology MHP - Troy
Troy, Michigan 48098
United States
Recruiting Site Public Contact
248-338-0663
Metro Health Hospital
Wyoming, Michigan 49519
United States
Recruiting Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota 56601
United States
Recruiting Site Public Contact
218-333-5000
OncologyClinicalTrialsFargo@sanfordhealth.org
Miller-Dwan Hospital
Duluth, Minnesota 55805
United States
Recruiting Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org
Fairview Southdale Hospital
Edina, Minnesota 55435
United States
Recruiting Site Public Contact
952-993-1517
mmcorc@healthpartners.com
Unity Hospital
Fridley, Minnesota 55432
United States
Recruiting Site Public Contact
952-993-1517
mmcorc@healthpartners.com
Mayo Clinic in Rochester
Rochester, Minnesota 55905
United States
Recruiting Site Public Contact
855-776-0015
Parkland Health Center-Bonne Terre
Bonne Terre, Missouri 63628
United States
Suspended
Saint Francis Medical Center
Cape Girardeau, Missouri 63703
United States
Recruiting Site Public Contact
573-334-2230
sfmc@sfmc.net
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri 63141
United States
Recruiting Site Public Contact
800-600-3606
info@siteman.wustl.edu
University of Kansas Cancer Center - North
Kansas City, Missouri 64154
United States
Recruiting Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri 64064
United States
Recruiting Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu
Washington University School of Medicine
Saint Louis, Missouri 63110
United States
Recruiting Site Public Contact
800-600-3606
info@siteman.wustl.edu
Siteman Cancer Center-South County
Saint Louis, Missouri 63129
United States
Recruiting Site Public Contact
800-600-3606
info@siteman.wustl.edu
Missouri Baptist Medical Center
Saint Louis, Missouri 63131
United States
Recruiting Site Public Contact
314-996-5569
Siteman Cancer Center at Saint Peters Hospital
Saint Peters, Missouri 63376
United States
Recruiting Site Public Contact
800-600-3606
info@siteman.wustl.edu
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri 63670
United States
Recruiting Site Public Contact
314-996-5569
Missouri Baptist Sullivan Hospital
Sullivan, Missouri 63080
United States
Recruiting Site Public Contact
314-996-5569
Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills, Missouri 63127
United States
Recruiting Site Public Contact
314-996-5569
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana 59405
United States
Recruiting Site Public Contact
406-969-6060
mccinfo@mtcancer.org
CHI Health Good Samaritan
Kearney, Nebraska 68847
United States
Recruiting Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org
Nebraska Methodist Hospital
Omaha, Nebraska 68114
United States
Recruiting Site Public Contact
402-354-5144
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada 89128
United States
Recruiting Site Public Contact
702-384-0013
research@sncrf.org
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas, Nevada 89144
United States
Recruiting Site Public Contact
702-384-0013
research@sncrf.org
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada 89148
United States
Recruiting Site Public Contact
702-384-0013
research@sncrf.org
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada 89169
United States
Recruiting Site Public Contact
702-384-0013
research@sncrf.org
Renown Regional Medical Center
Reno, Nevada 89502
United States
Recruiting Site Public Contact
702-384-0013
research@sncrf.org
University of Rochester
Rochester, New York 14642
United States
Recruiting Site Public Contact
585-275-5830
State University of New York Upstate Medical University
Syracuse, New York 13210
United States
Recruiting Site Public Contact
315-464-5476
Vidant Oncology-Kenansville
Kenansville, North Carolina 28349
United States
Recruiting Site Public Contact
252-559-2201
Carla.Zimmerman@vidanthealth.com
Vidant Oncology-Kinston
Kinston, North Carolina 28501
United States
Recruiting Site Public Contact
252-559-2201
Carla.Zimmerman@vidanthealth.com
Vidant Oncology-Richlands
Richlands, North Carolina 28574
United States
Suspended
Sanford Bismarck Medical Center
Bismarck, North Dakota 58501
United States
Recruiting Site Public Contact
701-323-5760
OncologyClinicalTrialsFargo@sanfordhealth.org
Sanford Broadway Medical Center
Fargo, North Dakota 58122
United States
Recruiting Site Public Contact
701-323-5760
OncologyClinicalTrialsFargo@sanfordhealth.org
Sanford Roger Maris Cancer Center
Fargo, North Dakota 58122
United States
Recruiting Site Public Contact
701-234-6161
OncologyClinicalTrialsFargo@sanfordhealth.org
University of Cincinnati/Barrett Cancer Center
Cincinnati, Ohio 45219
United States
Recruiting Site Public Contact
513-558-4553
uchealthnews@uc.edu
MetroHealth Medical Center
Cleveland, Ohio 44109
United States
Recruiting Site Public Contact
216-778-8526
dstrater@metrohealth.org
Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
United States
Recruiting Site Public Contact
800-293-5066
Jamesline@osumc.edu
Kettering Medical Center
Kettering, Ohio 45429
United States
Recruiting Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org
University Pointe
West Chester, Ohio 45069
United States
Recruiting Site Public Contact

clinicaltrials@ucphysicians.com
Cancer Centers of Southwest Oklahoma Research
Lawton, Oklahoma 73505
United States
Recruiting Site Public Contact
877-231-4440
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United States
Recruiting Site Public Contact
405-271-8777
ou-clinical-trials@ouhsc.edu
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania 18103
United States
Recruiting Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
Geisinger Medical Center
Danville, Pennsylvania 17822
United States
Suspended
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania 17033-0850
United States
Recruiting Site Public Contact
717-531-3779
CTO@hmc.psu.edu
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania 17837
United States
Recruiting Site Public Contact
570-374-8555
HemonCCTrials@geisinger.edu
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania 15232
United States
Recruiting Site Public Contact
412-647-8073
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania 15232
United States
Recruiting Site Public Contact
412-621-2334
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania 18711
United States
Recruiting Site Public Contact
570-271-5251
HemonCCTrials@geisinger.edu
Medical University of South Carolina
Charleston, South Carolina 29425
United States
Recruiting Site Public Contact
843-792-9321
hcc-clinical-trials@musc.edu
Prisma Health Cancer Institute - Faris
Greenville, South Carolina 29605
United States
Recruiting Site Public Contact
864-522-2066
kim.williams3@prismahealth.org
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina 29615
United States
Recruiting Site Public Contact
864-522-2066
kim.williams3@prismahealth.org
Prisma Health Cancer Institute - Greer
Greer, South Carolina 29650
United States
Recruiting Site Public Contact
864-522-2066
kim.williams3@prismahealth.org
Spartanburg Medical Center
Spartanburg, South Carolina 29303
United States
Recruiting Site Public Contact
864-560-6104
kmertz-rivera@gibbscc.org
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota 57104
United States
Recruiting Site Public Contact
605-312-3320
OncologyClinicTrialsSF@sanfordhealth.org
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota 57117-5134
United States
Recruiting Site Public Contact
605-312-3320
OncologyClinicalTrialsSF@SanfordHealth.org
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee 37232
United States
Recruiting Site Public Contact
800-811-8480
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas 75390
United States
Recruiting Site Public Contact
214-648-7097
canceranswerline@UTSouthwestern.edu
University of Texas Medical Branch
Galveston, Texas 77555-0565
United States
Active, not recruiting
UT Southwestern Clinical Center at Richardson/Plano
Richardson, Texas 75080
United States
Recruiting Site Public Contact
972-669-7044
Suzanne.cole@utsouthwestern.edu
Augusta Health Center for Cancer and Blood Disorders
Fishersville, Virginia 22939
United States
Recruiting Site Public Contact
540-332-5960
MultiCare Auburn Medical Center
Auburn, Washington 98001
United States
Suspended
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton, Washington 98310
United States
Recruiting Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org
MultiCare Gig Harbor Medical Park
Gig Harbor, Washington 98335
United States
Suspended
Seattle Cancer Care Alliance at EvergreenHealth
Kirkland, Washington 98034
United States
Recruiting Site Public Contact
425-899-6000
MultiCare Good Samaritan Hospital
Puyallup, Washington 98372
United States
Suspended
Seattle Cancer Care Alliance
Seattle, Washington 98109
United States
Recruiting Site Public Contact
800-804-8824
University of Washington Medical Center
Seattle, Washington 98195
United States
Recruiting Site Public Contact
800-804-8824
MultiCare Tacoma General Hospital
Tacoma, Washington 98405
United States
Suspended
West Virginia University Healthcare
Morgantown, West Virginia 26506
United States
Recruiting Site Public Contact
304-293-7374
cancertrialsinfo@hsc.wvu.edu
Northwest Wisconsin Cancer Center
Ashland, Wisconsin 54806
United States
Recruiting Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org
Mayo Clinic Health System-Eau Claire Clinic
Eau Claire, Wisconsin 54701
United States
Recruiting Site Public Contact
855-776-0015
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin 54601
United States
Recruiting Site Public Contact
855-776-0015
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin 53215
United States
Recruiting Site Public Contact
414-302-2304
ncorp@aurora.org
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin 54548
United States
Recruiting Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org
Cancer Center of Western Wisconsin
New Richmond, Wisconsin 54017
United States
Recruiting Site Public Contact
952-993-1517
mmcorc@healthpartners.com
Marshfield Clinic Stevens Point Center
Stevens Point, Wisconsin 54482
United States
Recruiting Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org
Diagnostic and Treatment Center
Weston, Wisconsin 54476
United States
Recruiting Site Public Contact
888-799-3989
oncology.clinical.trials@marshfieldresearch.org
Marshfield Clinic - Weston Center
Weston, Wisconsin 54476
United States
Recruiting Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org