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NCT05806515RecruitingPhase 2

Carboplatin Chemotherapy Before Surgery for People With High-Risk Prostate Cancer and an Inherited BRCA1 or BRCA2 Gene Mutation

S2210 A Phase II Study of Neoadjuvant Carboplatin for Localized, High Risk Prostate Cancer With Germline BRCA1/2 Mutations

Source: ClinicalTrials.gov · Last updated 29 Jan 2026

Brief summary (registry, in English)

This phase II trial tests how well carboplatin before surgery works in treating patients with high-risk prostate cancer and an inherited BRCA1 or BRCA2 gene mutation. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping, or slowing the growth of tumor cells. Giving carboplatin before surgery may shrink tumors in patients with high-risk prostate cancer with BRCA1 and BRCA2 gene mutations.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
44 (estimated)
First submitted
28 Mar 2023
Start date
1 Mar 2024
Primary completion date
Jul 2027
Lead sponsor
SWOG Cancer Research Network
NCT number
NCT05806515

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 44
  • From 1 Mar 2024 to the primary completion date, Jul 2027
  • 133 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participant must not have evidence of distant metastatic disease by conventional imaging within 90 days prior to registration
    • NOTE: cN1 detected only by PSMA-PET is permitted if urologist deems sites of disease to be potentially completely resectable
  • Participant must not have received prior radiation therapy (RT) to the pelvic region
  • Participant must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of protocol treatment

Who the study is looking for

  • Participant must have histologic diagnosis of prostate adenocarcinoma
  • Participant must have high or very high-risk disease defined by at least one of the following:
    • cT3a - cT4x
    • Grade group 4 or 5 (Gleason sum 8-10)
    • PSA \> 20 ng/mL prior to registration
  • Participant must have documented evidence of germline mutation (pathogenic/likely pathogenic variant) in BRCA2 or BRCA1 through testing in a Clinical Laboratory Improvement Act (CLIA)-certified lab
    • NOTE: Local lab report is sufficient for eligibility
  • Participant may have initiated gonadotrophin releasing hormone (gnRH) agonist, gnRH antagonist, oral anti-androgen (e.g. bicalutamide, nilutamide, flutamide), or other agent intended to treat prostate cancer prior to registration. The effectiveness of the current depot of such treatment must not extend beyond 1 month after study registration. Agents listed above cannot be started after participant registration
  • Participant must be \>= 18 years old
  • Participant must have Zubrod performance status of 0-2
  • Participant must have a complete medical history and physical exam within 28 days prior to registration
  • Absolute neutrophil count \>= 1.5 x 10\^3/uL (within 28 days prior to registration)
  • Platelets \>= 100 x 10\^3/uL (within 28 days prior to registration)
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3 x institutional upper limit of normal (ULN) (within 28 days prior to registration)
  • Participant must have a serum creatinine =\< the institutional upper limit of normal (IULN) OR measured OR calculated creatinine clearance \>= 50 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration
  • Participant must have adequate cardiac function. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification within 28 days prior to registration. To be eligible for this trial, participants must be class 2B or better
  • Participant with known human immunodeficiency virus (HIV)-infection must be receiving anti-retroviral therapy and have an undetectable viral load test within 6 months prior to registration
  • Participant with history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on suppressive therapy within in 28 days prior to registration
  • Participant with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment must have an undetectable HCV viral load within in 28 days prior to registration
  • Participants who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including vasectomy with testing showing no sperm in the semen
  • Prior to registration, participant must have had a urologic consult and be deemed a surgical candidate with known sites of disease deemed by the urologist to be potentially resectable
  • Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System
  • NOTE: As a part of the 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
    • Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines
    • For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations
    • As part of the 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

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (133)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Providence Regional Cancer System-Aberdeen
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AberdeenUnited StatesRecruiting
Community Hospital of Anaconda
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AnacondaUnited StatesRecruiting
Katmai Oncology Group
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AnchorageUnited StatesRecruiting
Alaska Breast Care and Surgery LLC
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AnchorageUnited StatesRecruiting
Anchorage Oncology Centre
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AnchorageUnited StatesRecruiting
Alaska Oncology and Hematology LLC
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AnchorageUnited StatesRecruiting
Anchorage Radiation Therapy Center
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AnchorageUnited StatesRecruiting
Providence Alaska Medical Center
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AnchorageUnited StatesRecruiting
Alaska Women's Cancer Care
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AnchorageUnited StatesRecruiting
Anchorage Associates in Radiation Medicine
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AnchorageUnited StatesRecruiting
Mission Hope Medical Oncology - Arroyo Grande
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Arroyo GrandeUnited StatesRecruiting
Saint Alphonsus Medical Center-Baker City
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Baker CityUnited StatesRecruiting
Flaget Memorial Hospital
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BardstownUnited StatesRecruiting
PeaceHealth Saint Joseph Medical Center
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BellinghamUnited StatesRecruiting
Saint Charles Health System
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BendUnited StatesRecruiting
Billings Clinic Cancer Center
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BillingsUnited StatesRecruiting
Saint Luke's Cancer Institute - Boise
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BoiseUnited StatesRecruiting
Saint Alphonsus Cancer Care Center-Boise
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BoiseUnited StatesRecruiting
Bozeman Deaconess Hospital
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BozemanUnited StatesRecruiting
Harrison Medical Center
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BremertonUnited StatesRecruiting
Providence Saint Joseph Medical Center/Disney Family Cancer Center
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BurbankUnited StatesRecruiting
Saint Alphonsus Cancer Care Center-Caldwell
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CaldwellUnited StatesRecruiting
Mercy San Juan Medical Center
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CarmichaelUnited StatesRecruiting
Mercy Cancer Center - Carmichael
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CarmichaelUnited StatesRecruiting
Providence Regional Cancer System-Centralia
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CentraliaUnited StatesRecruiting
TriHealth Cancer Institute-Anderson
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CincinnatiUnited StatesRecruiting
Bethesda North Hospital
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CincinnatiUnited StatesRecruiting
TriHealth Cancer Institute-Westside
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CincinnatiUnited StatesRecruiting
Good Samaritan Hospital - Cincinnati
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CincinnatiUnited StatesRecruiting
Clackamas Radiation Oncology Center
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ClackamasUnited StatesRecruiting
Providence Cancer Institute Clackamas Clinic
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ClackamasUnited StatesRecruiting
Billings Clinic-Cody
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CodyUnited StatesRecruiting
Kootenai Health - Coeur d'Alene
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Coeur d'AleneUnited StatesRecruiting
Rocky Mountain Cancer Centers-Penrose
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Colorado SpringsUnited StatesRecruiting
Saint Francis Cancer Center
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Colorado SpringsUnited StatesRecruiting
Penrose-Saint Francis Healthcare
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Colorado SpringsUnited StatesRecruiting
Bay Area Hospital
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Coos BayUnited StatesRecruiting
Commonwealth Cancer Center-Corbin
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CorbinUnited StatesRecruiting
Alegent Health Mercy Hospital
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Council BluffsUnited StatesRecruiting
Porter Adventist Hospital
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DenverUnited StatesRecruiting
Smilow Cancer Hospital-Derby Care Center
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DerbyUnited StatesRecruiting
City of Hope Comprehensive Cancer Center
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DuarteUnited StatesRecruiting
Southwest Oncology PC
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DurangoUnited StatesRecruiting
Mercy Medical Center
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DurangoUnited StatesRecruiting
Swedish Cancer Institute-Edmonds
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EdmondsUnited StatesRecruiting
Mercy Cancer Center - Elk Grove
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Elk GroveUnited StatesRecruiting
Walter Knox Memorial Hospital
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EmmettUnited StatesRecruiting
NorthShore University HealthSystem-Evanston Hospital
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EvanstonUnited StatesRecruiting
Providence Regional Cancer Partnership
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EverettUnited StatesRecruiting
Smilow Cancer Hospital Care Center-Fairfield
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FairfieldUnited StatesRecruiting
Saint Luke's Cancer Institute - Fruitland
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FruitlandUnited StatesRecruiting
Smilow Cancer Hospital Care Center at Glastonbury
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GlastonburyUnited StatesRecruiting
NorthShore University HealthSystem-Glenbrook Hospital
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GlenviewUnited StatesRecruiting
Benefis Healthcare- Sletten Cancer Institute
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Great FallsUnited StatesRecruiting
Great Falls Clinic
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Great FallsUnited StatesRecruiting
Smilow Cancer Hospital Care Center at Greenwich
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GreenwichUnited StatesRecruiting
Smilow Cancer Hospital Care Center - Guilford
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GuilfordUnited StatesRecruiting
Smilow Cancer Hospital Care Center at Saint Francis
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HartfordUnited StatesRecruiting
NorthShore University HealthSystem-Highland Park Hospital
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Highland ParkUnited StatesRecruiting
City of Hope at Irvine Lennar
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IrvineUnited StatesRecruiting
Swedish Cancer Institute-Issaquah
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IssaquahUnited StatesRecruiting
Kalispell Regional Medical Center
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KalispellUnited StatesRecruiting
CHI Health Good Samaritan
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KearneyUnited StatesRecruiting
Kadlec Clinic Hematology and Oncology
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KennewickUnited StatesRecruiting
Providence Regional Cancer System-Lacey
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LaceyUnited StatesRecruiting
Saint Anthony Hospital
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LakewoodUnited StatesRecruiting
Saint Joseph Radiation Oncology Resource Center
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LexingtonUnited StatesRecruiting
Saint Joseph Hospital
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LexingtonUnited StatesRecruiting
Saint Joseph Hospital East
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LexingtonUnited StatesRecruiting
Saint Elizabeth Regional Medical Center
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LincolnUnited StatesRecruiting
Littleton Adventist Hospital
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LittletonUnited StatesRecruiting
Saint Joseph London
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LondonUnited StatesRecruiting
Longmont United Hospital
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LongmontUnited StatesRecruiting
PeaceHealth Saint John Medical Center
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LongviewUnited StatesRecruiting
Saint Luke's Cancer Institute - Meridian
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MeridianUnited StatesRecruiting
Idaho Urologic Institute-Meridian
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MeridianUnited StatesRecruiting
LSU Healthcare Network / Metairie Multi-Specialty Clinic
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MetairieUnited StatesRecruiting
Garnet Health Medical Center
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MiddletownUnited StatesRecruiting
Saint Patrick Hospital - Community Hospital
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MissoulaUnited StatesRecruiting
Community Medical Hospital
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MissoulaUnited StatesSuspended
Saint Joseph Mount Sterling
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Mount SterlingUnited StatesRecruiting
Saint Luke's Cancer Institute - Nampa
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NampaUnited StatesRecruiting
Saint Alphonsus Cancer Care Center-Nampa
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NampaUnited StatesRecruiting
Providence Queen of The Valley
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NapaUnited StatesRecruiting
Providence Newberg Medical Center
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NewbergUnited StatesRecruiting
Smilow Cancer Center/Yale-New Haven Hospital
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New HavenUnited StatesRecruiting
Yale University
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New HavenUnited StatesRecruiting
Louisiana State University Health Science Center
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New OrleansUnited StatesRecruiting
Yale-New Haven Hospital North Haven Medical Center
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North HavenUnited StatesRecruiting
University of Oklahoma Health Sciences Center
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Oklahoma CityUnited StatesRecruiting
Creighton University Medical Center
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OmahaUnited StatesRecruiting
Alegent Health Lakeside Hospital
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OmahaUnited StatesRecruiting
Alegent Health Immanuel Medical Center
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OmahaUnited StatesRecruiting
Alegent Health Bergan Mercy Medical Center
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OmahaUnited StatesRecruiting
Saint Alphonsus Medical Center-Ontario
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OntarioUnited StatesRecruiting
Providence Willamette Falls Medical Center
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Oregon CityUnited StatesRecruiting
Midlands Community Hospital
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PapillionUnited StatesRecruiting
Parker Adventist Hospital
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ParkerUnited StatesRecruiting
Cancer Center at Saint Joseph's
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PhoenixUnited StatesRecruiting
Providence Portland Medical Center
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PortlandUnited StatesRecruiting
Oregon Health and Science University
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PortlandUnited StatesRecruiting
Providence Saint Vincent Medical Center
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PortlandUnited StatesRecruiting
Kootenai Clinic Cancer Services - Post Falls
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Post FallsUnited StatesRecruiting
Saint Mary Corwin Medical Center
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PuebloUnited StatesRecruiting
Saint Charles Health System-Redmond
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RedmondUnited StatesRecruiting
Mercy Cancer Center - Rocklin
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RocklinUnited StatesRecruiting
Mercy Cancer Center - Sacramento
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SacramentoUnited StatesRecruiting
Kootenai Cancer Clinic
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SandpointUnited StatesRecruiting
Pacific Central Coast Health Center-San Luis Obispo
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San Luis ObispoUnited StatesRecruiting
Mission Hope Medical Oncology - Santa Maria
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Santa MariaUnited StatesRecruiting
Providence Medical Foundation - Santa Rosa
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Santa RosaUnited StatesRecruiting
Providence Santa Rosa Memorial Hospital
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Santa RosaUnited StatesRecruiting
Swedish Medical Center-First Hill
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SeattleUnited StatesRecruiting
Swedish Medical Center-Ballard Campus
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SeattleUnited StatesRecruiting
Swedish Medical Center-Cherry Hill
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SeattleUnited StatesRecruiting
FHCC South Lake Union
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SeattleUnited StatesRecruiting
Fred Hutchinson Cancer Research Center
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SeattleUnited StatesRecruiting
University of Washington Medical Center - Montlake
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SeattleUnited StatesRecruiting
PeaceHealth United General Medical Center
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Sedro-WoolleyUnited StatesRecruiting
Providence Regional Cancer System-Shelton
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SheltonUnited StatesRecruiting
Welch Cancer Center
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SheridanUnited StatesRecruiting
North Shore Medical Center
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SkokieUnited StatesRecruiting
Smilow Cancer Hospital Care Center at Long Ridge
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StamfordUnited StatesRecruiting
Smilow Cancer Hospital-Torrington Care Center
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TorringtonUnited StatesRecruiting
Smilow Cancer Hospital Care Center-Trumbull
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TrumbullUnited StatesRecruiting
Saint Luke's Cancer Institute - Twin Falls
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Twin FallsUnited StatesRecruiting
PeaceHealth Southwest Medical Center
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VancouverUnited StatesRecruiting
Providence Saint Mary Regional Cancer Center
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Walla WallaUnited StatesRecruiting
Smilow Cancer Hospital-Waterbury Care Center
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WaterburyUnited StatesRecruiting
Smilow Cancer Hospital Care Center - Waterford
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WaterfordUnited StatesRecruiting
Smilow Cancer Hospital Care Center - Westerly
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WesterlyUnited StatesRecruiting
Woodland Memorial Hospital
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WoodlandUnited StatesRecruiting
Providence Regional Cancer System-Yelm
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YelmUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.