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BRIEF TITLE: A Phase II Study of Dose-Dense Gemcitabine Plus Cisplatin (ddGC) in Patients With Muscle-Invasive Bladder Cancer With Bladder Preservation for Those Patients Whose Tumors Harbor Deleterious DNA Damage Response (DDR) Gene Alterations

A Phase II Study of Dose-Dense Gemcitabine Plus Cisplatin (ddGC) in Patients With Muscle-Invasive Bladder Cancer With Bladder Preservation for Those Patients Whose Tumors Harbor Deleterious DNA Damage Response (DDR) Gene Alterations


  • Org Study ID: A031701
  • Secondary ID: NCI-2018-01531,U10CA180821
  • NCT ID: NCT03609216
  • NCT Alias:
  • Sponsor: Alliance for Clinical Trials in Oncology - Other
  • Source: Alliance for Clinical Trials in Oncology

Brief Summary

This phase II trial studies how well gemcitabine hydrochloride and cisplatin work in treating participants with invasive bladder urothelial cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Detailed Description


PRIMARY OBJECTIVES:

I. To determine the 3-year event free survival, defined as the proportion of patients without
invasive or metastatic recurrence following definitive dose dense gemcitabine hydrochloride
(gemcitabine) and cisplatin chemotherapy in those patients whose pre-treatment transurethral
resection of bladder tumor (TURBT) tumors harbor deleterious DDR gene alterations and who
achieve < cT1 response to chemotherapy.

SECONDARY OBJECTIVES:

I. To determine the clinical response rate (< cT1) for patients harboring deleterious DDR
gene alterations following dose dense gemcitabine and cisplatin.

II. To determine the bladder-intact and overall survival for DDR-altered patients with < cT1.

III. For DDR gene altered patients who elect radical cystectomy despite < cT1, to determine
the pT0 rate in this patient population.

IV. To determine the pathologic response rate at cystectomy and 3-year recurrence-free and
overall survival for patients without DDR mutations who are registered onto this trial.

V. To assess the local treatment burden (Bacillus Calmette-Guerin [BCG] therapy, resection of
non-invasive disease) over time in the bladder-sparing group.

OUTLINE:

Participants receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on day 1,
cisplatin IV on days 1 and 2, and pegfilgrastim subcutaneously (SC) on day 3. Treatment
repeats every 14 days for up to 6 courses in the absence of disease progression or unaccepted
toxicity. Participants are then assigned to 1 of 2 arms.

ARM I: Participants with DDR gene alteration and disease stage < cT1 undergo bladder sparing.

ARM II: Participants with DDR gene alteration and disease stage >= cT1 or participants
without DDR gene alteration undergo radical cystectomy or chemoradiotherapy.

After completion of study treatment, participants are followed up for 5 years.

Overal Status Start Date Phase Study Type
Recruiting August 1, 2018 Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Proportion of patients who are recurrence-free within the DDR mutated group who undergo the bladder sparing approach

Primary Outcome 1 - Time Frame: At 3 years

Condition:

  • Infiltrating Bladder Urothelial Carcinoma
  • Stage II Bladder Urothelial Carcinoma
  • Stage III Bladder Urothelial Carcinoma

Eligibility

Criteria:
Inclusion Criteria:

- Step 1 Patient Registration Eligibility Criteria

- Histologically confirmed muscle-invasive urothelial carcinoma of the bladder.
Urothelial carcinoma invading into the prostatic stroma with no histologic muscle
invasion is allowed, provided the extent of disease is confirmed via imaging and/or
examination under anesthesia (EUA). The diagnostic TURBT sample must have been
obtained within 60 days prior to registration

- 20 unstained slides (10 micron thickness) of formalin-fixed paraffin-embedded (FFPE)
pre-treatment diagnostic transurethral resection (TUR) specimen available (for
sequencing), with 2 (5 micron) slides at the start and end of the 20 slides, for a
total of 22 unstained slides. An FFPE block is also acceptable

- Clinical stage T2-T4aN0/xM0 disease

- Medically appropriate candidate for radical cystectomy as assessed by surgeon

- No concomitant multifocal carcinoma in situ; a single focus is allowed

- One focus of muscle-invasive bladder cancer and/or a tumor < 5 cm in size

- No clinical or radiographic evidence for locally advanced or metastatic disease

- No prior anti-PD-1, anti PD-L1 therapies, or systemic chemotherapy (prior intravesical
induction immunotherapy for non-muscle invasive disease is allowed, defined as BCG x 6
treatments; BCG refractory disease, defined as disease recurrence within 3 months of
BCG therapy, is not allowed)

- No prior radiation therapy to the bladder

- No major surgery or radiation therapy =< 4 weeks of registration

- Not pregnant and not nursing. This study involves an agent that has known genotoxic,
mutagenic and teratogenic effects. For women of childbearing potential only, a
negative pregnancy test done =< 14 days prior to registration is required

- Eastern Cooperative Oncology Group (ECOG) performance status 0-1

- Absolute neutrophil count (ANC) >= 1,000/mm^3

- Platelet count >= 100,000/mm^3

- Calculated creatinine clearance >= 55 mL/min

- Total bilirubin =< 1.5 x upper limit of normal (ULN)

* (For patients with documented Gilbert's syndrome bilirubin =< 3 x ULN)

- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x ULN

- Alkaline phosphatase =< 2.5 x ULN

- No hydronephrosis refractory to urinary diversion

- No evidence of New York Heart Association (NYHA) functional class III or IV heart
disease

- No ongoing cardiac dysrhythmias of National Cancer Institute (NCI) Common Terminology
Criteria for Adverse Events (CTCAE) version 5.0 grade >= 2

- No pre-existing sensory grade >= 2 neuropathy

- No pre-existing grade >= 2 hearing loss

- No serious intercurrent medical or psychiatric illness, including serious active
infection

- None of the following within the 6 months prior to study drug administration:
myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass
graft, symptomatic congestive heart failure, cerebrovascular accident, or transient
ischemic attack

- No known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome
(AIDS)-related illness or other active infection. HIV-positive patients on combination
antiretroviral therapy are ineligible because of the potential for pharmacokinetic
interactions with the drugs used in this trial. In addition, these patients are at
increased risk of lethal infections when treated with marrow-suppressive therapy.
Appropriate studies will be undertaken in patients receiving combination
antiretroviral therapy, when indicated

- No history of allergic reaction attributed to compounds of similar chemical or
biologic composition to the agents used in this study

- No concurrent treatment on another clinical trial; supportive care trials or
non-therapeutic trials (e.g., quality of life) are allowed

- No prior malignancy except for: adequately treated basal 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. Patients with localized prostate cancer who are
being followed by an active surveillance program are also eligible

- Step 2 Patient Registration Eligibility Criteria

- Patients must have completed 4 or more cycles of protocol-directed chemotherapy

- Step 3 Patient Registration Eligibility Criteria (only patients with a DDR gene
alteration)

- Deleterious alteration within 1 or more of 9 pre-defined DDR genes within the
pre-treatment TURBT deoxyribonucleic acid (DNA)

- Cystoscopy and imaging performed to determine stage/treatment assignment
Show More

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Gopa Iyer, MD

Role: Study Chair

Affiliation: Memorial Sloan Kettering Cancer Center

Overall Contact

Name: Gopa Iyer, MD

Phone: 646-888-4737

Email: iyerg@mskcc.org

Locations

Facility Status Contact
CHI Saint Vincent Cancer Center Hot Springs
Hot Springs, Arkansas 71913
United States
Recruiting Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org
Fremont - Rideout Cancer Center
Marysville, California 95901
United States
Recruiting Site Public Contact
530-749-4400
University of California Davis Comprehensive Cancer Center
Sacramento, California 95817
United States
Recruiting Site Public Contact
916-734-3089
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado 80907
United States
Recruiting Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado 80907
United States
Recruiting Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org
Porter Adventist Hospital
Denver, Colorado 80210
United States
Recruiting Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org
Mercy Medical Center
Durango, Colorado 81301
United States
Suspended
Southwest Oncology PC
Durango, Colorado 81301
United States
Suspended
Mountain Blue Cancer Care Center
Golden, Colorado 80401
United States
Suspended
Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado 80228
United States
Suspended
Saint Anthony Hospital
Lakewood, Colorado 80228
United States
Recruiting Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org
Littleton Adventist Hospital
Littleton, Colorado 80122
United States
Recruiting Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org
Longmont United Hospital
Longmont, Colorado 80501
United States
Recruiting Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org
Rocky Mountain Cancer Centers-Longmont
Longmont, Colorado 80501
United States
Suspended
Parker Adventist Hospital
Parker, Colorado 80138
United States
Suspended
Rocky Mountain Cancer Centers-Parker
Parker, Colorado 80138
United States
Suspended
Saint Mary Corwin Medical Center
Pueblo, Colorado 81004
United States
Recruiting Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org
Rocky Mountain Cancer Centers - Pueblo
Pueblo, Colorado 81008
United States
Suspended
Rocky Mountain Cancer Centers-Thornton
Thornton, Colorado 80260
United States
Recruiting Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho 83706
United States
Recruiting Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho 83605
United States
Recruiting Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
Kootenai Medical Center
Coeur d'Alene, Idaho 83814
United States
Suspended
Walter Knox Memorial Hospital
Emmett, Idaho 83617
United States
Suspended
Idaho Urologic Institute-Meridian
Meridian, Idaho 83642
United States
Recruiting Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
Saint Alphonsus Medical Center-Nampa
Nampa, Idaho 83686
United States
Suspended
Kootenai Cancer Center
Post Falls, Idaho 83854
United States
Recruiting Site Public Contact
406-969-6060
mccinfo@mtcancer.org
Kootenai Cancer Clinic
Sandpoint, Idaho 83864
United States
Suspended
Illinois CancerCare-Bloomington
Bloomington, Illinois 61704
United States
Suspended
Illinois CancerCare-Canton
Canton, Illinois 61520
United States
Suspended
Memorial Hospital of Carbondale
Carbondale, Illinois 62902
United States
Recruiting Site Public Contact
618-457-5200
clinical.research@sih.net
SIH Cancer Institute
Carterville, Illinois 62918
United States
Recruiting Site Public Contact
618-985-3333
clinical.research@sih.net
Illinois CancerCare-Carthage
Carthage, Illinois 62321
United States
Suspended
Centralia Oncology Clinic
Centralia, Illinois 62801
United States
Recruiting Site Public Contact
217-876-4740
rhamrick@dmhhs.org
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
United States
Recruiting Site Public Contact
217-876-4740
rhamrick@dmhhs.org
Decatur Memorial Hospital
Decatur, Illinois 62526
United States
Recruiting Site Public Contact
217-876-4740
rhamrick@dmhhs.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
Suspended
Illinois CancerCare-Galesburg
Galesburg, Illinois 61401
United States
Suspended
Western Illinois Cancer Treatment Center
Galesburg, Illinois 61401
United States
Recruiting Site Public Contact
309-344-2831
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois 61443
United States
Suspended
Illinois CancerCare-Macomb
Macomb, Illinois 61455
United States
Suspended
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
Suspended
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
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
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
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
OSF Saint Francis Medical Center
Peoria, Illinois 61637
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
Valley Radiation Oncology
Peru, Illinois 61354
United States
Recruiting Site Public Contact
815-664-4141
Illinois CancerCare-Princeton
Princeton, Illinois 61356
United States
Recruiting Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com
Southern Illinois University School of Medicine
Springfield, Illinois 62702
United States
Recruiting Site Public Contact
217-545-7929
Springfield Clinic
Springfield, Illinois 62702
United States
Recruiting Site Public Contact
800-444-7541
Memorial Medical Center
Springfield, Illinois 62781
United States
Recruiting Site Public Contact
217-788-3528
Cancer Care Specialists of Illinois-Swansea
Swansea, Illinois 62226
United States
Recruiting Site Public Contact
217-876-4740
rhamrick@dmhhs.org
Southwest Illinois Health Services LLP
Swansea, Illinois 62226
United States
Recruiting Site Public Contact
618-236-1000
lynns@thecancercenter.com
Reid Health
Richmond, Indiana 47374
United States
Recruiting Site Public Contact
937-775-1350
som_dcop@wright.edu
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
Alegent Health Mercy Hospital
Council Bluffs, Iowa 51503
United States
Suspended
Greater Regional Medical Center
Creston, Iowa 50801
United States
Suspended
Iowa Methodist Medical Center
Des Moines, Iowa 50309
United States
Recruiting Site Public Contact
515-241-6727
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa 50309
United States
Recruiting Site Public Contact
515-282-2921
Broadlawns Medical Center
Des Moines, Iowa 50314
United States
Recruiting Site Public Contact
515-282-2200
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
Iowa Lutheran Hospital
Des Moines, Iowa 50316
United States
Recruiting Site Public Contact
515-241-8704
Trinity Regional Medical Center
Fort Dodge, Iowa 50501
United States
Suspended
Methodist West Hospital
West Des Moines, Iowa 50266-7700
United States
Recruiting Site Public Contact
515-343-1000
Mercy Medical Center-West Lakes
West Des Moines, Iowa 50266
United States
Recruiting Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org
Flaget Memorial Hospital
Bardstown, Kentucky 40004
United States
Suspended
Commonwealth Cancer Center-Corbin
Corbin, Kentucky 40701
United States
Suspended
Saint Joseph Radiation Oncology Resource Center
Lexington, Kentucky 40504
United States
Recruiting Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org
Saint Joseph Hospital East
Lexington, Kentucky 40509
United States
Recruiting Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org
Saint Joseph London
London, Kentucky 40741
United States
Suspended
Jewish Hospital
Louisville, Kentucky 40202
United States
Recruiting Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org
Saints Mary and Elizabeth Hospital
Louisville, Kentucky 40215
United States
Suspended
Jewish Hospital Medical Center Northeast
Louisville, Kentucky 40245
United States
Recruiting Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org
Jewish Hospital Medical Center South
Shepherdsville, Kentucky 40165
United States
Suspended
East Jefferson General Hospital
Metairie, Louisiana 70006
United States
Recruiting Site Public Contact
504-210-3539
trials@jeffradonc.com
Louisiana State University Health Science Center
New Orleans, Louisiana 70112
United States
Recruiting Site Public Contact
504-568-2428
emede1@lsuhsc.edu
University Medical Center New Orleans
New Orleans, Louisiana 70112
United States
Recruiting Site Public Contact
504-903-3000
emede1@lsuhsc.edu
Ochsner Medical Center Jefferson
New Orleans, Louisiana 70121
United States
Recruiting Site Public Contact
504-703-8712
Gregory.Johnstone@ochsner.org
Mercy Medical Center
Springfield, Massachusetts 01104
United States
Suspended
Saint Joseph Mercy Hospital
Ann Arbor, Michigan 48106
United States
Recruiting Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
IHA Hematology Oncology Consultants-Brighton
Brighton, Michigan 48114
United States
Suspended
Saint Joseph Mercy Brighton
Brighton, Michigan 48114
United States
Suspended
IHA Hematology Oncology Consultants-Canton
Canton, Michigan 48188
United States
Suspended
Saint Joseph Mercy Canton
Canton, Michigan 48188
United States
Suspended
Caro Cancer Center
Caro, Michigan 48723
United States
Suspended
IHA Hematology Oncology Consultants-Chelsea
Chelsea, Michigan 48118
United States
Suspended
Saint Joseph Mercy Chelsea
Chelsea, Michigan 48118
United States
Suspended
Hematology Oncology Consultants-Clarkston
Clarkston, Michigan 48346
United States
Suspended
Newland Medical Associates-Clarkston
Clarkston, Michigan 48346
United States
Suspended
Ascension Saint John Hospital
Detroit, Michigan 48236
United States
Recruiting Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
Great Lakes Cancer Management Specialists-Doctors Park
East China Township, Michigan 48054
United States
Suspended
Genesee Cancer and Blood Disease Treatment Center
Flint, Michigan 48503
United States
Suspended
Genesee Hematology Oncology PC
Flint, Michigan 48503
United States
Suspended
Genesys Hurley Cancer Institute
Flint, Michigan 48503
United States
Recruiting Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
Hurley Medical Center
Flint, Michigan 48503
United States
Recruiting Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Grosse Pointe Woods, Michigan 48236
United States
Suspended
Lymphoma Clinic of Michigan
Grosse Pointe Woods, Michigan 48236
United States
Suspended
Michigan Breast Specialists-Grosse Pointe Woods
Grosse Pointe Woods, Michigan 48236
United States
Suspended
Sparrow Hospital
Lansing, Michigan 48912
United States
Recruiting Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
Hope Cancer Clinic
Livonia, Michigan 48154
United States
Suspended
Saint Mary Mercy Hospital
Livonia, Michigan 48154
United States
Recruiting Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
Great Lakes Cancer Management Specialists-Macomb Medical Campus
Macomb, Michigan 48044
United States
Suspended
Michigan Breast Specialists-Macomb Township
Macomb, Michigan 48044
United States
Suspended
Saint Mary's Oncology/Hematology Associates of Marlette
Marlette, Michigan 48453
United States
Suspended
21st Century Oncology-Pontiac
Pontiac, Michigan 48341
United States
Recruiting Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
Hope Cancer Center
Pontiac, Michigan 48341
United States
Suspended
Newland Medical Associates-Pontiac
Pontiac, Michigan 48341
United States
Suspended
Saint Joseph Mercy Oakland
Pontiac, Michigan 48341
United States
Recruiting Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
Great Lakes Cancer Management Specialists-Rochester Hills
Rochester Hills, Michigan 48309
United States
Suspended
Saint Mary's of Michigan
Saginaw, Michigan 48601
United States
Recruiting Site Public Contact
773-702-9171
protocols@AllianceNCTN.org
Oncology Hematology Associates of Saginaw Valley PC
Saginaw, Michigan 48604
United States
Suspended
Bhadresh Nayak MD PC-Sterling Heights
Sterling Heights, Michigan 48312
United States
Suspended
Saint Joseph Health System-Tawas City
Tawas City, Michigan 48764
United States
Suspended
Advanced Breast Care Center PLLC
Warren, Michigan 48088
United States
Suspended
Great Lakes Cancer Management Specialists-Macomb Professional Building
Warren, Michigan 48093
United States
Suspended
Macomb Hematology Oncology PC
Warren, Michigan 48093
United States
Suspended
Michigan Breast Specialists-Warren
Warren, Michigan 48093
United States
Suspended
Saint John Macomb-Oakland Hospital
Warren, Michigan 48093
United States
Recruiting Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
Saint Mary's Oncology/Hematology Associates of West Branch
West Branch, Michigan 48661
United States
Suspended
Huron Gastroenterology PC
Ypsilanti, Michigan 48106
United States
Suspended
IHA Hematology Oncology Consultants-Ann Arbor
Ypsilanti, Michigan 48197
United States
Suspended
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota 56601
United States
Recruiting Site Public Contact
218-333-5000
Fairview Ridges Hospital
Burnsville, Minnesota 55337
United States
Recruiting Site Public Contact
952-993-1517
mmcorc@healthpartners.com
Mercy Hospital
Coon Rapids, Minnesota 55433
United States
Recruiting Site Public Contact
952-993-1517
mmcorc@healthpartners.com
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
Fairview Maple Grove Medical Center
Maple Grove, Minnesota 55369
United States
Recruiting Site Public Contact
952-993-1517
mmcorc@healthpartners.com
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota 55109
United States
Recruiting Site Public Contact
952-993-1517
mmcorc@healthpartners.com
Saint John's Hospital - Healtheast
Maplewood, Minnesota 55109
United States
Recruiting Site Public Contact
773-702-9171
protocols@AllianceNCTN.org
Abbott-Northwestern Hospital
Minneapolis, Minnesota 55407
United States
Recruiting Site Public Contact
952-993-1517
mmcorc@healthpartners.com
Hennepin County Medical Center
Minneapolis, Minnesota 55415
United States
Recruiting Site Public Contact
952-993-1517
mmcorc@healthpartners.com
Health Partners Inc
Minneapolis, Minnesota 55454
United States
Recruiting Site Public Contact
952-993-1517
mmcorc@healthpartners.com
Monticello Cancer Center
Monticello, Minnesota 55362
United States
Recruiting Site Public Contact
952-993-1517
mmcorc@healthpartners.com
New Ulm Medical Center
New Ulm, Minnesota 56073
United States
Suspended
North Memorial Medical Health Center
Robbinsdale, Minnesota 55422
United States
Recruiting Site Public Contact
952-993-1517
mmcorc@healthpartners.com
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota 55416
United States
Recruiting Site Public Contact
952-993-1517
mmcorc@healthpartners.com
Regions Hospital
Saint Paul, Minnesota 55101
United States
Recruiting Site Public Contact
952-993-1517
mmcorc@healthpartners.com
United Hospital
Saint Paul, Minnesota 55102
United States
Recruiting Site Public Contact
952-993-1517
mmcorc@healthpartners.com
Saint Francis Regional Medical Center
Shakopee, Minnesota 55379
United States
Recruiting Site Public Contact
952-993-1517
mmcorc@healthpartners.com
Lakeview Hospital
Stillwater, Minnesota 55082
United States
Recruiting Site Public Contact
952-993-1517
mmcorc@healthpartners.com
Sanford Thief River Falls Medical Center
Thief River Falls, Minnesota 56701
United States
Suspended
Ridgeview Medical Center
Waconia, Minnesota 55387
United States
Recruiting Site Public Contact
952-993-1517
mmcorc@healthpartners.com
Rice Memorial Hospital
Willmar, Minnesota 56201
United States
Recruiting Site Public Contact
952-993-1517
mmcorc@healthpartners.com
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota 55125
United States
Recruiting Site Public Contact
952-993-1517
mmcorc@healthpartners.com
Sanford Cancer Center Worthington
Worthington, Minnesota 56187
United States
Suspended
Fairview Lakes Medical Center
Wyoming, Minnesota 55092
United States
Suspended
Parkland Health Center-Bonne Terre
Bonne Terre, Missouri 63628
United States
Recruiting Site Public Contact
314-996-5569
Saint Francis Medical Center
Cape Girardeau, Missouri 63703
United States
Recruiting Site Public Contact
573-334-2230
sfmc@sfmc.net
Southeast Cancer Center
Cape Girardeau, Missouri 63703
United States
Recruiting Site Public Contact
573-651-5550
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri 63141
United States
Recruiting Site Public Contact
800-600-3606
info@siteman.wustl.edu
Capital Region Southwest Campus
Jefferson City, Missouri 65109
United States
Recruiting Site Public Contact
573-632-4814
swooden@mail.crmc.org
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
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
Community Hospital of Anaconda
Anaconda, Montana 59711
United States
Suspended
Billings Clinic Cancer Center
Billings, Montana 59101
United States
Recruiting Site Public Contact
800-996-2663
research@billingsclinic.org
Bozeman Deaconess Hospital
Bozeman, Montana 59715
United States
Recruiting Site Public Contact
406-969-6060
mccinfo@mtcancer.org
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana 59405
United States
Recruiting Site Public Contact
406-969-6060
mccinfo@mtcancer.org
Great Falls Clinic
Great Falls, Montana 59405
United States
Suspended
Saint Peter's Community Hospital
Helena, Montana 59601
United States
Suspended
Kalispell Regional Medical Center
Kalispell, Montana 59901
United States
Recruiting Site Public Contact
406-969-6060
mccinfo@mtcancer.org
Community Medical Hospital
Missoula, Montana 59804
United States
Recruiting Site Public Contact
406-969-6060
mccinfo@mtcancer.org
CHI Health Saint Francis
Grand Island, Nebraska 68803
United States
Recruiting Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org
Heartland Hematology and Oncology
Kearney, Nebraska 68845
United States
Suspended
CHI Health Good Samaritan
Kearney, Nebraska 68847
United States
Recruiting Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org
Saint Elizabeth Regional Medical Center
Lincoln, Nebraska 68510
United States
Suspended
Alegent Health Immanuel Medical Center
Omaha, Nebraska 68122
United States
Recruiting Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org
Hematology and Oncology Consultants PC
Omaha, Nebraska 68122
United States
Suspended
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska 68124
United States
Recruiting Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org
Alegent Health Lakeside Hospital
Omaha, Nebraska 68130
United States
Recruiting Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org
Creighton University Medical Center
Omaha, Nebraska 68131
United States
Recruiting Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org
Midlands Community Hospital
Papillion, Nebraska 68046
United States
Suspended
Englewood Hospital and Medical Center
Englewood, New Jersey 07631
United States
Recruiting Site Public Contact
201-894-3456
Roswell Park Cancer Institute
Buffalo, New York 14263
United States
Recruiting Site Public Contact
800-767-9355
askroswell@roswellpark.org
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Recruiting Site Public Contact
212-639-7592
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina 28328
United States
Suspended
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina 27534
United States
Suspended
Wayne Memorial Hospital
Goldsboro, North Carolina 27534
United States
Suspended
Onslow Memorial Hospital
Jacksonville, North Carolina 28546
United States
Suspended
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina 28546
United States
Suspended
Sanford Bismarck Medical Center
Bismarck, North Dakota 58501
United States
Recruiting Site Public Contact
701-323-5760
tamara.fischer@sanfordhealth.org
Sanford South University Medical Center
Fargo, North Dakota 58103
United States
Suspended
Sanford Medical Center Fargo
Fargo, North Dakota 58104
United States
Suspended
Roger Maris Cancer Center
Fargo, North Dakota 58122
United States
Recruiting Site Public Contact
701-234-6161
Sanford Broadway Medical Center
Fargo, North Dakota 58122
United States
Recruiting Site Public Contact
800-437-4010
Indu and Raj Soin Medical Center
Beavercreek, Ohio 45431
United States
Recruiting Site Public Contact
937-775-1350
som_dcop@wright.edu
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio 45459
United States
Recruiting Site Public Contact
937-775-1350
som_dcop@wright.edu
Miami Valley Hospital South
Centerville, Ohio 45459
United States
Recruiting Site Public Contact
937-775-1350
som_dcop@wright.edu
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio 45220
United States
Recruiting Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio 45236
United States
Recruiting Site Public Contact
937-775-1350
som_dcop@wright.edu
Bethesda North Hospital
Cincinnati, Ohio 45242
United States
Recruiting Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org
TriHealth Cancer Institute-Westside
Cincinnati, Ohio 45247
United States
Suspended
TriHealth Cancer Institute-Anderson
Cincinnati, Ohio 45255
United States
Suspended
Good Samaritan Hospital - Dayton
Dayton, Ohio 45406
United States
Recruiting Site Public Contact
937-775-1350
som_dcop@wright.edu
Miami Valley Hospital
Dayton, Ohio 45409
United States
Recruiting Site Public Contact
937-775-1350
som_dcop@wright.edu
Dayton Physicians LLC-Samaritan North
Dayton, Ohio 45415
United States
Recruiting Site Public Contact
937-775-1350
som_dcop@wright.edu
Miami Valley Hospital North
Dayton, Ohio 45415
United States
Recruiting Site Public Contact
937-775-1350
som_dcop@wright.edu
Armes Family Cancer Center
Findlay, Ohio 45840
United States
Recruiting Site Public Contact
937-775-1350
som_dcop@wright.edu
Blanchard Valley Hospital
Findlay, Ohio 45840
United States
Recruiting Site Public Contact
937-775-1350
som_dcop@wright.edu
Orion Cancer Care
Findlay, Ohio 45840
United States
Recruiting Site Public Contact
937-775-1350
som_dcop@wright.edu
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio 45005-1066
United States
Recruiting Site Public Contact
937-775-1350
som_dcop@wright.edu
Dayton Physicians LLC-Atrium
Franklin, Ohio 45005
United States
Recruiting Site Public Contact
937-775-1350
som_dcop@wright.edu
Dayton Physicians LLC-Wayne
Greenville, Ohio 45331
United States
Recruiting Site Public Contact
937-775-1350
som_dcop@wright.edu
Wayne Hospital
Greenville, Ohio 45331
United States
Recruiting Site Public Contact
937-775-1350
som_dcop@wright.edu
Greater Dayton Cancer Center
Kettering, Ohio 45409
United States
Recruiting Site Public Contact
937-775-1350
som_dcop@wright.edu
First Dayton Cancer Care
Kettering, Ohio 45420
United States
Suspended
Kettering Medical Center
Kettering, Ohio 45429
United States
Recruiting Site Public Contact
937-775-1350
som_dcop@wright.edu
Springfield Regional Cancer Center
Springfield, Ohio 45504
United States
Recruiting Site Public Contact
937-775-1350
som_dcop@wright.edu
Springfield Regional Medical Center
Springfield, Ohio 45505
United States
Recruiting Site Public Contact
937-775-1350
som_dcop@wright.edu
Dayton Physicians LLC-Upper Valley
Troy, Ohio 45373
United States
Recruiting Site Public Contact
937-775-1350
som_dcop@wright.edu
Upper Valley Medical Center
Troy, Ohio 45373
United States
Recruiting Site Public Contact
937-775-1350
som_dcop@wright.edu
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United States
Recruiting Site Public Contact
405-271-8777
ou-clinical-trials@ouhsc.edu
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma 74146
United States
Recruiting Site Public Contact
918-505-3200
Saint Alphonsus Medical Center-Baker City
Baker City, Oregon 97814
United States
Suspended
Saint Alphonsus Medical Center-Ontario
Ontario, Oregon 97914
United States
Suspended
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania 18103
United States
Recruiting Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania 18017
United States
Recruiting Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
Pocono Medical Center
East Stroudsburg, Pennsylvania 18301
United States
Recruiting Site Public Contact
570-422-1700
ann.foster@lvhn.org
Lehigh Valley Hospital-Hazleton
Hazleton, Pennsylvania 18201
United States
Suspended
Greenville Health System Cancer Institute-Laurens
Clinton, South Carolina 29325
United States
Suspended
Greenville Health System Cancer Institute-Easley
Easley, South Carolina 29640
United States
Suspended
Greenville Health System Cancer Institute-Butternut
Greenville, South Carolina 29605
United States
Suspended
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina 29605
United States
Recruiting Site Public Contact
864-241-6251
kwilliams8@ghs.org
Greenville Memorial Hospital
Greenville, South Carolina 29605
United States
Suspended
Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina 29615
United States
Recruiting Site Public Contact
864-241-6251
kwilliams8@ghs.org
Greenville Health System Cancer Institute-Greer
Greer, South Carolina 29650
United States
Recruiting Site Public Contact
864-241-6251
kwilliams8@ghs.org
Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina 29672
United States
Recruiting Site Public Contact
864-241-6251
kwilliams8@ghs.org
Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina 29307
United States
Recruiting Site Public Contact
864-241-6251
kwilliams8@ghs.org
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota 57104
United States
Recruiting Site Public Contact
605-312-3320
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota 57117-5134
United States
Recruiting Site Public Contact
605-312-3320
OncologyClinicalTrialsSF@SanfordHealth.org
Memorial Hospital
Chattanooga, Tennessee 37404
United States
Recruiting Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org
Pulmonary Medicine Center of Chattanooga-Hixson
Hixson, Tennessee 37343
United States
Suspended
Memorial GYN Plus
Ooltewah, Tennessee 37363
United States
Suspended
Saint Joseph Regional Cancer Center
Bryan, Texas 77802
United States
Recruiting Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton, Washington 98310
United States
Recruiting Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org
Harrison Medical Center
Bremerton, Washington 98310
United States
Recruiting Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org
Highline Medical Center-Main Campus
Burien, Washington 98166
United States
Recruiting Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org
Saint Elizabeth Hospital
Enumclaw, Washington 98022
United States
Suspended
Saint Francis Hospital
Federal Way, Washington 98003
United States
Suspended
Saint Clare Hospital
Lakewood, Washington 98499
United States
Suspended
Harrison HealthPartners Hematology and Oncology-Poulsbo
Poulsbo, Washington 98370
United States
Suspended
Franciscan Research Center-Northwest Medical Plaza
Tacoma, Washington 98405
United States
Suspended
Northwest Medical Specialties PLLC
Tacoma, Washington 98405
United States
Recruiting Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org
United Hospital Center
Bridgeport, West Virginia 26330
United States
Recruiting Site Public Contact
304-293-7374
cancertrialsinfo@hsc.wvu.edu
WVUH-Berkely Medical Center
Martinsburg, West Virginia 25401
United States
Suspended
West Virginia University Healthcare
Morgantown, West Virginia 26506
United States
Recruiting Site Public Contact
304-293-7374
cancertrialsinfo@hsc.wvu.edu
Camden Clark Medical Center
Parkersburg, West Virginia 26101
United States
Recruiting Site Public Contact
304-293-7374
cancertrialsinfo@hsc.wvu.edu
Cancer Center of Western Wisconsin
New Richmond, Wisconsin 54017
United States
Recruiting Site Public Contact
952-993-1517
mmcorc@healthpartners.com
Billings Clinic-Cody
Cody, Wyoming 82414
United States
Suspended
Welch Cancer Center
Sheridan, Wyoming 82801
United States
Suspended