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NCT07441681RecruitingPhase 3

Comparing Radiation Plus Cetuximab to Radiation Plus Chemotherapy in People With Advanced Head and Neck Cancer Who Cannot Receive Cisplatin

Radiotherapy With Concurrent Cetuximab vs. Carboplatin and Paclitaxel in Patients With Locoregionally Advanced Head and Neck Cancer With a Contraindication to Cisplatin: A Pragmatic Phase III Randomized Trial (CONCISE)

Source: ClinicalTrials.gov · Last updated 27 Oct 2026

Brief summary (registry, in English)

This phase III trial compares cetuximab to chemotherapy, carboplatin and paclitaxel, with intensity modulated radiation therapy for the treatment of patients with head and neck cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) who are unable to receive cisplatin. Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of cancer cells. This may help keep cancer cells from growing. 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 cancer cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Intensity modulated radiation therapy is a type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. It is not yet know if cetuximab or chemotherapy, with intensity modulated radiation therapy works best for the treatment of patients with advanced head and neck cancer who are unable to receive cisplatin.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
454 (estimated)
First submitted
24 Feb 2026
Start date
31 Jul 2026
Primary completion date
30 Nov 2035
Lead sponsor
NRG Oncology
NCT number
NCT07441681

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 454
  • From 31 Jul 2026 to the primary completion date, 30 Nov 2035
  • 150 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.

Who the study is looking for

  • Patients must have pathologically confirmed, previously untreated, unresected squamous cell carcinoma of the larynx, hypopharynx, oropharynx, or oral cavity
  • Local evaluation of p16 status is required for all oropharynx patients prior to registration
  • Local evaluation of p16 status is recommended for non-oropharynx patients prior to registration
  • Locoregionally advanced head and neck squamous cell carcinoma (HNSCC) defined as:
    • Non-oropharynx and p16-negative oropharynx cancer: American Joint Commission on Cancer (AJCC) 9th edition stage III-IVB
    • Eligible Laryngeal, Hypopharyngeal, Oral Cavity, and p16-Negative Oropharyngeal Primaries:
    • AJCC 9th Edition TNM: T3 N0 or T1-3 N1 M0; AJCC 9th Edition Stage: III
    • AJCC 9th Edition TNM: T1-3 N2 or T4a N0-N2 M0; AJCC 9th Edition Stage: IVA
    • AJCC 9th Edition TNM: T4b N0-N2 or T1-4b N3 M0; AJCC 9th Edition Stage: IVB
    • p16-positive oropharynx cancer: AJCC 9th edition stage II-III
    • Eligible p16-Positive Oropharyngeal Primaries
    • AJCC 9th Edition TNM: T3 N0-2 or T1-2 N2 M0; AJCC 9th Edition Stage: II
    • AJCC 9th Edition TNM: T4 N0-3 or T1-3 N3 M0; AJCC 9th Edition Stage: III
  • The following are required prior to registration:
    • Imaging of the head and neck with a neck CT or MRI (with contrast, unless contraindicated) or PET/CT which includes diagnostic-quality CT of the neck (with contrast, unless contraindicated)
    • Chest imaging: Chest CT (with contrast, unless contraindicated) or PET/CT
  • Age ≥ 18
  • Complete the online tool at www.nrgoncology.org prior to registration and record the (modified) Charleston Comorbidity Index (CCI), Head and Neck Cancer Intergroup (HNCIG) omega, and G-8 scores on the registration form in Oncology Patient Enrollment Network (OPEN)
  • Patients must have a contraindication to cisplatin as defined in the following bullet points:
    • Absolute or relative contraindication to cisplatin, defined as ONE OR MORE of the following prior to registration:
    • Creatinine clearance (CrCl) \< 60 mL/min by the Cockroft-Gault formula
    • Pre-existing peripheral (sensory or motor) neuropathy grade ≥ 2 (per Common Terminology Criteria for Adverse Events \[CTCAE\] version \[v\] 5.0)
    • History of hearing loss, defined as either:
    • Existing need of a hearing aid OR
    • ≥ 25 decibel shift over 2 contiguous frequencies on a pretreatment hearing test as clinically indicated OR
    • age ≥ 70 with Head and Neck Cancer Intergroup (HNCIG) omega score \< 0.80 prior to registration OR
    • Age \< 70 with ALL of the following conditions prior to registration (see Appendix II for calculation instructions):
    • HNCIG omega score \< 0.80
    • (Modified) Charlson Comorbidity Index (CCI) ≥ 1
    • G-8 score ≤ 14
  • Not pregnant and not nursing
  • Participants must be able to safely receive the radiation and drug regimens per current Food and Drug Administration (FDA)-approved package insert(s), treating investigator's discretion, and institutional guidelines
  • No prior systemic therapy for the study cancer; note that prior systemic therapy for a different cancer is allowable
  • No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • No prior surgery for the study cancer

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

Full criteria on ClinicalTrials.gov

Sites (150)

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

SiteCityCountrySite status
University of New Mexico Cancer Center
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AlbuquerqueUnited StatesRecruiting
Mary Greeley Medical Center
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AmesUnited StatesRecruiting
McFarland Clinic - Ames
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AmesUnited StatesRecruiting
Kaiser Permanente-Anaheim
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AnaheimUnited StatesRecruiting
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
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Ann ArborUnited StatesRecruiting
Aspirus Cancer Care-Antigo-Volm Cancer Center
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AntigoUnited StatesRecruiting
Emory University Hospital Midtown
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AtlantaUnited StatesRecruiting
Emory Proton Therapy Center
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AtlantaUnited StatesRecruiting
Kaiser Permanente-Baldwin Park
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Baldwin ParkUnited StatesRecruiting
Bay Pines VA Healthcare System
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Bay PinesUnited StatesRecruiting
Kaiser Permanente-Bellflower
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BellflowerUnited StatesRecruiting
Sanford Joe Lueken Cancer Center
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BemidjiUnited StatesRecruiting
Saint Charles Health System
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BendUnited StatesRecruiting
Tower Cancer Research Foundation
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Beverly HillsUnited StatesRecruiting
University of Alabama at Birmingham Cancer Center
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BirminghamUnited StatesRecruiting
Sanford Bismarck Medical Center
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BismarckUnited StatesRecruiting
OSF Saint Joseph Medical Center
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BloomingtonUnited StatesRecruiting
Illinois CancerCare-Bloomington
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BloomingtonUnited StatesRecruiting
Lafayette Family Cancer Center-EMMC
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BrewerUnited StatesRecruiting
Trinity Health IHA Medical Group Hematology Oncology - Brighton
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BrightonUnited StatesRecruiting
Sands Cancer Center
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CanandaiguaUnited StatesRecruiting
Trinity Health IHA Medical Group Hematology Oncology - Canton
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CantonUnited StatesRecruiting
Trinity Health Medical Center - Canton
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CantonUnited StatesRecruiting
Illinois CancerCare-Canton
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CantonUnited StatesRecruiting
Saint Francis Medical Center
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Cape GirardeauUnited StatesRecruiting
Illinois CancerCare-Carthage
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CarthageUnited StatesRecruiting
Mercy Hospital
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Cedar RapidsUnited StatesRecruiting
Oncology Associates at Mercy Medical Center
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Cedar RapidsUnited StatesRecruiting
Christiana Care Health System-Concord Health Center
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Chadds FordUnited StatesRecruiting
Medical University of South Carolina
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CharlestonUnited StatesRecruiting
Chelsea Hospital
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ChelseaUnited StatesRecruiting
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
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ChelseaUnited StatesRecruiting
Northwestern University
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ChicagoUnited StatesRecruiting
University of Cincinnati Cancer Center-UC Medical Center
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CincinnatiUnited StatesRecruiting
Clackamas Radiation Oncology Center
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ClackamasUnited StatesRecruiting
Mercy Cancer Center-West Lakes
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CliveUnited StatesRecruiting
Noyes Memorial Hospital/Myers Cancer Center
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DansvilleUnited StatesRecruiting
Carle at The Riverfront
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DanvilleUnited StatesRecruiting
Geisinger Medical Center
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DanvilleUnited StatesRecruiting
Cancer Care Specialists of Illinois - Decatur
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DecaturUnited StatesRecruiting
Decatur Memorial Hospital
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DecaturUnited StatesRecruiting
Northwestern Medicine Cancer Center Kishwaukee
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DeKalbUnited StatesRecruiting
Mercy Medical Center - Des Moines
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Des MoinesUnited StatesRecruiting
Geisinger Cancer Center Dickson City
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Dickson CityUnited StatesRecruiting
Carle Physician Group-Effingham
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EffinghamUnited StatesRecruiting
Illinois CancerCare-Eureka
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EurekaUnited StatesRecruiting
Sanford Roger Maris Cancer Center
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FargoUnited StatesRecruiting
Sanford Broadway Medical Center
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FargoUnited StatesRecruiting
Kaiser Permanente-Fontana
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FontanaUnited StatesRecruiting
Illinois CancerCare-Galesburg
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GalesburgUnited StatesRecruiting
Northwestern Medicine Cancer Center Delnor
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GenevaUnited StatesRecruiting
Northwestern Medicine Glenview Outpatient Center
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GlenviewUnited StatesRecruiting
Northwestern Medicine Grayslake Outpatient Center
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GrayslakeUnited StatesRecruiting
Kaiser Permanente South Bay
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Harbor CityUnited StatesRecruiting
Penn State Milton S. Hershey Medical Center
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HersheyUnited StatesRecruiting
Methodist Willowbrook Hospital
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HoustonUnited StatesRecruiting
Kaiser Permanente-Irvine
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IrvineUnited StatesRecruiting
University of Wisconsin Carbone Cancer Center - Johnson Creek
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Johnson CreekUnited StatesRecruiting
University of Kansas Cancer Center
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Kansas CityUnited StatesRecruiting
University of Kansas Cancer Center - North
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Kansas CityUnited StatesRecruiting
University of Kansas Cancer Center - Briarcliff
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Kansas CityUnited StatesRecruiting
Illinois CancerCare-Kewanee Clinic
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KewaneeUnited StatesRecruiting
Northwestern Medicine Lake Forest Hospital
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Lake ForestUnited StatesRecruiting
University of Michigan Health - Sparrow Lansing
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LansingUnited StatesRecruiting
Lawrence Memorial Hospital
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LawrenceUnited StatesRecruiting
University of Kansas Cancer Center - Lee's Summit
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Lee's SummitUnited StatesRecruiting
Geisinger Medical Oncology-Lewisburg
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LewisburgUnited StatesRecruiting
University of Kentucky/Markey Cancer Center
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LexingtonUnited StatesRecruiting
Trinity Health Saint Mary Mercy Livonia Hospital
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LivoniaUnited StatesRecruiting
Kaiser Permanente Los Angeles Medical Center
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Los AngelesUnited StatesRecruiting
USC / Norris Comprehensive Cancer Center
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Los AngelesUnited StatesRecruiting
Cedars-Sinai Medical Center
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Los AngelesUnited StatesRecruiting
Kaiser Permanente West Los Angeles
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Los AngelesUnited StatesRecruiting
The Angeles Clinic and Research Institute - West Los Angeles Office
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Los AngelesUnited StatesRecruiting
UofL Health Medical Center Northeast
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LouisvilleUnited StatesRecruiting
The James Graham Brown Cancer Center at University of Louisville
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LouisvilleUnited StatesRecruiting
Illinois CancerCare-Macomb
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MacombUnited StatesRecruiting
University of Wisconsin Carbone Cancer Center - University Hospital
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MadisonUnited StatesRecruiting
William S Middleton VA Medical Center
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MadisonUnited StatesRecruiting
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
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MadisonUnited StatesRecruiting
Carle Physician Group-Mattoon/Charleston
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MattoonUnited StatesRecruiting
Froedtert Menomonee Falls Hospital
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Menomonee FallsUnited StatesRecruiting
Medical College of Wisconsin
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MilwaukeeUnited StatesRecruiting
Zablocki Veterans Administration Medical Center
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MilwaukeeUnited StatesRecruiting
West Virginia University Healthcare
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MorgantownUnited StatesRecruiting
Vanderbilt University/Ingram Cancer Center
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NashvilleUnited StatesRecruiting
Vanderbilt Breast Center at One Hundred Oaks
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NashvilleUnited StatesRecruiting
Christiana Care Health System-Christiana Hospital
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NewarkUnited StatesRecruiting
Medical Oncology Hematology Consultants PA
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NewarkUnited StatesRecruiting
Helen F Graham Cancer Center
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NewarkUnited StatesRecruiting
Providence Newberg Medical Center
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NewbergUnited StatesRecruiting
Froedtert and MCW Moorland Reserve Health Center
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New BerlinUnited StatesRecruiting
Northwestern Medicine Oak Brook
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Oak BrookUnited StatesRecruiting
Drexel Town Square Health Center
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Oak CreekUnited StatesRecruiting
Cancer Care Center of O'Fallon
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O'FallonUnited StatesRecruiting
HSHS Saint Elizabeth's Hospital
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O'FallonUnited StatesRecruiting
University of Oklahoma Health Sciences Center
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Oklahoma CityUnited StatesRecruiting
Kaiser Permanente-Ontario
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OntarioUnited StatesRecruiting
Providence Willamette Falls Medical Center
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Oregon CityUnited StatesRecruiting
Northwestern Medicine Orland Park
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Orland ParkUnited StatesRecruiting
Illinois CancerCare-Ottawa Clinic
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OttawaUnited StatesRecruiting
University of Kansas Hospital-Indian Creek Campus
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Overland ParkUnited StatesRecruiting
University of Kansas Cancer Center-Overland Park
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Overland ParkUnited StatesRecruiting
Stanford Cancer Institute Palo Alto
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Palo AltoUnited StatesRecruiting
Kaiser Permanente - Panorama City
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Panorama CityUnited StatesRecruiting
Illinois CancerCare-Pekin
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PekinUnited StatesRecruiting
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
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PeoriaUnited StatesRecruiting
OSF Saint Francis Medical Center
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PeoriaUnited StatesRecruiting
Illinois CancerCare-Peoria
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PeoriaUnited StatesRecruiting
Illinois CancerCare-Peru
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PeruUnited StatesRecruiting
Fox Chase Cancer Center
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PhiladelphiaUnited StatesRecruiting
Temple University Hospital
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PhiladelphiaUnited StatesRecruiting
Providence Saint Vincent Medical Center
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PortlandUnited StatesRecruiting
Providence Portland Medical Center
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PortlandUnited StatesRecruiting
Illinois CancerCare-Princeton
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PrincetonUnited StatesRecruiting
Aspirus Cancer Care-Rhinelander-James Beck Cancer Center
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RhinelanderUnited StatesRecruiting
VCU Massey Comprehensive Cancer Center
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RichmondUnited StatesRecruiting
VCU Massey Cancer Center at Stony Point
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RichmondUnited StatesRecruiting
Kaiser Permanente-Riverside
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RiversideUnited StatesRecruiting
University of Rochester
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RochesterUnited StatesRecruiting
Wilmot Cancer Institute Radiation Oncology at Greece
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RochesterUnited StatesRecruiting
Highland Hospital
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RochesterUnited StatesRecruiting
UW Health Carbone Cancer Center Rockford
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RockfordUnited StatesRecruiting
Salina Regional Health Center
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SalinaUnited StatesRecruiting
Kaiser Permanente-San Diego Zion
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San DiegoUnited StatesRecruiting
Stanford Cancer Center South Bay
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San JoseUnited StatesRecruiting
Kaiser Permanente-San Marcos
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San MarcosUnited StatesRecruiting
Sanford Cancer Center Oncology Clinic
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Sioux FallsUnited StatesRecruiting
Sanford USD Medical Center - Sioux Falls
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Sioux FallsUnited StatesRecruiting
Aspirus Cancer Care - Stevens Point
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Stevens PointUnited StatesRecruiting
Stony Brook University Medical Center
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Stony BrookUnited StatesRecruiting
ProMedica Flower Hospital
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SylvaniaUnited StatesRecruiting
Montefiore Medical Center - Moses Campus
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The BronxUnited StatesRecruiting
Montefiore Medical Center-Einstein Campus
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The BronxUnited StatesRecruiting
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
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ToledoUnited StatesRecruiting
University of Kansas Health System Saint Francis Campus
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TopekaUnited StatesRecruiting
Carle Cancer Center
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UrbanaUnited StatesRecruiting
Northwestern Medicine Cancer Center Warrenville
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WarrenvilleUnited StatesRecruiting
Illinois CancerCare - Washington
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WashingtonUnited StatesRecruiting
Aspirus Cancer Care-Wausau
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WausauUnited StatesRecruiting
Wilmot Cancer Institute at Webster
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WebsterUnited StatesRecruiting
Froedtert West Bend Hospital/Kraemer Cancer Center
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West BendUnited StatesRecruiting
University of Cincinnati Cancer Center-West Chester
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West ChesterUnited StatesRecruiting
Mercy Medical Center-West Lakes
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West Des MoinesUnited StatesRecruiting
University of Kansas Hospital-Westwood Cancer Center
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WestwoodUnited StatesRecruiting
Geisinger Wyoming Valley/Henry Cancer Center
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Wilkes-BarreUnited StatesRecruiting
Christiana Care Health System-Wilmington Hospital
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WilmingtonUnited StatesRecruiting
Aspirus Cancer Care - Wisconsin Rapids
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Wisconsin RapidsUnited StatesRecruiting
Kaiser Permanente-Woodland Hills
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Woodland HillsUnited StatesRecruiting
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
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YpsilantiUnited StatesRecruiting

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