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NCT07166406RecruitingPhase 3

Testing Immunotherapy With or Without Stereotactic Body Radiation Therapy in Patients With Advanced Liver Cancer, HELIO-RT Trial

Phase III Randomized Trial of IO-Based Systemic Treatment +/- Liver SBRT in Hepatocellular Cancer With Macrovascular Invasion (HELIO-RT)

Source: ClinicalTrials.gov · Last updated 17 Aug 2026

Brief summary (registry, in English)

This phase III trial compares the effect of immunotherapy (IO) with stereotactic body radiation therapy (SBRT) to IO alone in treating patients with liver cancer (hepatocellular cancer) that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). The usual approach is treatment with IO-based drug combinations, such as atezolizumab and bevacizumab, durvalumab and tremelimumab, or ipilimumab and nivolumab. IO with monoclonal antibodies, such as durvalumab, tremelimumab, atezolizumab, nivolumab and ipilimumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor cells. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Giving IO with SBRT may be more effective than IO alone in helping patients with advanced hepatocellular cancer live longer.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
226 (estimated)
First submitted
3 Sept 2025
Start date
26 Feb 2026
Primary completion date
10 Mar 2029
Lead sponsor
NRG Oncology
NCT number
NCT07166406

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 226
  • From 26 Feb 2026 to the primary completion date, 10 Mar 2029
  • 139 sites in 2 countries
  • 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

  • PRIOR TO STEP 1 REGISTRATION:
  • Diagnosis of hepatocellular carcinoma (HCC) by at least 1 criterion listed below:
    • Pathologically (histologically or cytologically) proven diagnosis of HCC (strongly recommended)
    • Radiographically proven (American Association for the Study of Liver Diseases \[AASLD\] criteria) diagnosis of HCC by multiphasic MRI and/or CT scan is allowed.
    • For patients with a prior or concurrent malignancy, pathologic confirmation of hepatocellular cancer is required.
  • HCC macrovascular invasion, defined as enhancing vascular thrombosis demonstrating arterial enhancement and venous or delayed venous washout on multiphasic MRI and/or CT is required.
  • Presence of extrahepatic metastatic disease on CT chest and CT or MRI pelvis, or PET/CT chest/abdomen/pelvis is permitted.
  • 5 or fewer discrete intrahepatic parenchymal foci of HCC.
  • Total maximal sum of hepatocellular carcinoma tumors, as a single conglomerate, multiple lesions, or infiltrative HCC \< 20 cm in total summed diameter.
  • No direct primary tumor extension into the stomach, duodenum, small bowel, or large bowel.
  • No known fibrolamellar HCC, sarcomatoid HCC, or biphenotypic HCC.
  • Child-Pugh class A or B7 liver function.
  • Age ≥ 18.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • Not pregnant and not nursing
    • Negative urine or serum pregnancy test (in persons of childbearing potential) within 30 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal.
  • Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\^3.
  • Platelets ≥ 60,000 cells/mm\^3.
  • Hemoglobin ≥ 8g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin \[Hgb\] ≥ 8g/dl is acceptable).
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 6 x institutional upper limit of normal (ULN).
  • Total bilirubin \< 4 x institutional ULN.
  • Creatinine clearance (CrCL) ≥ 30 mL/min/1.73 m\^2 by the Cockcroft-Gault formula.
  • For treatment of HCC:
    • Prior surgical resection, transarterial chemoembolization (TACE), and ablation are permitted.
    • No prior systemic therapy or transarterial radioembolization (TARE) for HCC.
    • No history of liver transplantation.
  • For prior treatment for any malignancy:
    • Prior systemic therapy for a different cancer is allowable, except for prior immunotherapy.
    • No prior radiotherapy to the region of the study cancer that would result in significant overlap of radiation therapy fields that would lead to excessive cumulative toxicity at the discretion of the investigator.
  • No medical contraindication to the standard of care immunotherapy.
  • For patients to be treated with atezolizumab/bevacizumab:
    • No history of a gastrointestinal (GI) bleed or other clinically significant bleeding event within 6 months prior to study registration.
  • Systemic immunostimulatory agents (including, but not limited to, interferons and interleukin-2 \[IL-2\]) are prohibited within 4 weeks or five drug elimination half-lives (whichever is longer) prior to registration and during the study period.
  • No history of allergic reaction to the systemic therapy agent(s), compounds of similar chemical or biologic composition to the systemic therapy agent(s) (or any of its excipients).
  • PRIOR TO STEP 2 RANDOMIZATION:
  • Obtain confirmation of payment coverage (insurance or other) for both possible treatment arms.

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

Full criteria on ClinicalTrials.gov

Sites (139)

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

SiteCityCountrySite status
University Health Network, Princess Margaret Hospital
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TorontoCanadaRecruiting
University of New Mexico Cancer Center
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AlbuquerqueUnited StatesRecruiting
Inova Alexandria Hospital
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AlexandriaUnited StatesRecruiting
UI Health Care Mission Cancer and Blood - Ankeny Clinic
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AnkenyUnited StatesRecruiting
Duluth Clinic Ashland
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AshlandUnited StatesRecruiting
Northwest Wisconsin Cancer Center
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AshlandUnited StatesRecruiting
Emory Saint Joseph's Hospital
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AtlantaUnited StatesRecruiting
Emory University Hospital Midtown
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AtlantaUnited StatesRecruiting
Emory Proton Therapy Center
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AtlantaUnited StatesRecruiting
Grady Health System
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AtlantaUnited StatesRecruiting
Emory University Hospital/Winship Cancer Institute
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AtlantaUnited StatesRecruiting
UH Seidman Cancer Center at UH Avon Health Center
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AvonUnited StatesRecruiting
UHHS-Chagrin Highlands Medical Center
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BeachwoodUnited StatesRecruiting
Nebraska Medicine-Bellevue
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BellevueUnited StatesRecruiting
Alta Bates Summit Medical Center-Herrick Campus
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BerkeleyUnited StatesRecruiting
Massachusetts General Hospital Cancer Center
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BostonUnited StatesRecruiting
Essentia Health Saint Joseph's Medical Center
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BrainerdUnited StatesRecruiting
Henry Ford Cancer Institute-Downriver
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BrownstownUnited StatesRecruiting
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
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Cameron ParkUnited StatesRecruiting
Christiana Care Health System-Concord Health Center
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Chadds FordUnited StatesRecruiting
University of Illinois
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ChicagoUnited StatesRecruiting
University of Chicago Comprehensive Cancer Center
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ChicagoUnited StatesRecruiting
Siteman Cancer Center at Saint Peters Hospital
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City of Saint PetersUnited StatesRecruiting
Clackamas Radiation Oncology Center
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ClackamasUnited StatesRecruiting
Case Western Reserve University
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ClevelandUnited StatesRecruiting
Mercy Cancer Center-West Lakes
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CliveUnited StatesRecruiting
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
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CliveUnited StatesRecruiting
Rocky Mountain Cancer Centers-Penrose
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Colorado SpringsUnited StatesRecruiting
Memorial Hospital North
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Colorado SpringsUnited StatesRecruiting
UCHealth Memorial Hospital Central
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Colorado SpringsUnited StatesRecruiting
Ohio State University Comprehensive Cancer Center
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ColumbusUnited StatesRecruiting
Greater Regional Medical Center
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CrestonUnited StatesRecruiting
Siteman Cancer Center at West County Hospital
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Creve CoeurUnited StatesRecruiting
UChicago Medicine Northwest Indiana
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Crown PointUnited StatesRecruiting
Carle at The Riverfront
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DanvilleUnited StatesRecruiting
Geisinger Medical Center
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DanvilleUnited StatesRecruiting
Henry Ford Medical Center-Fairlane
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DearbornUnited StatesRecruiting
Essentia Health - Deer River Clinic
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Deer RiverUnited StatesRecruiting
Smilow Cancer Hospital-Derby Care Center
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DerbyUnited StatesRecruiting
Mercy Medical Center - Des Moines
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Des MoinesUnited StatesRecruiting
UI Health Care Mission Cancer and Blood - Des Moines Clinic
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Des MoinesUnited StatesRecruiting
Iowa Methodist Medical Center
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Des MoinesUnited StatesRecruiting
UI Health Care Mission Cancer and Blood - Laurel Clinic
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Des MoinesUnited StatesRecruiting
Henry Ford Hospital
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DetroitUnited StatesRecruiting
Geisinger Cancer Center Dickson City
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Dickson CityUnited StatesRecruiting
Essentia Health Cancer Center
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DuluthUnited StatesRecruiting
Essentia Health Saint Mary's Medical Center
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DuluthUnited StatesRecruiting
Miller-Dwan Hospital
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DuluthUnited StatesRecruiting
Duke University Medical Center
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DurhamUnited StatesRecruiting
Marshfield Medical Center-EC Cancer Center
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Eau ClaireUnited StatesRecruiting
Carle Physician Group-Effingham
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EffinghamUnited StatesRecruiting
Inova Fair Oaks Hospital
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FairfaxUnited StatesRecruiting
Inova Schar Cancer Institute
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FairfaxUnited StatesRecruiting
Smilow Cancer Hospital Care Center-Fairfield
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FairfieldUnited StatesRecruiting
Inova Fairfax Hospital
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Falls ChurchUnited StatesRecruiting
Cancer Care and Hematology-Fort Collins
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Fort CollinsUnited StatesRecruiting
Poudre Valley Hospital
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Fort CollinsUnited StatesRecruiting
Palo Alto Medical Foundation-Fremont
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FremontUnited StatesRecruiting
Smilow Cancer Hospital Care Center at Glastonbury
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GlastonburyUnited StatesRecruiting
Saint Mary's Hospital and Regional Medical Center
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Grand JunctionUnited StatesRecruiting
UCHealth Greeley Hospital
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GreeleyUnited 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-Hamden Care Center
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HamdenUnited StatesRecruiting
Smilow Cancer Hospital Care Center at Saint Francis
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HartfordUnited StatesRecruiting
Essentia Health-Hayward Clinic
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HaywardUnited StatesRecruiting
Essentia Health Hibbing Clinic
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HibbingUnited StatesRecruiting
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
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IrvineUnited StatesRecruiting
Allegiance Health
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JacksonUnited StatesRecruiting
Northwell Health/Center for Advanced Medicine
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Lake SuccessUnited StatesRecruiting
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
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LebanonUnited StatesRecruiting
Inova Loudoun Hospital
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LeesburgUnited StatesRecruiting
Geisinger Medical Oncology-Lewisburg
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LewisburgUnited StatesRecruiting
University of Kentucky/Markey Cancer Center
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LexingtonUnited StatesRecruiting
Medical Center of the Rockies
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LovelandUnited StatesRecruiting
Marshfield Medical Center-Marshfield
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MarshfieldUnited StatesRecruiting
Carle Physician Group-Mattoon/Charleston
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MattoonUnited StatesRecruiting
Froedtert Menomonee Falls Hospital
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Menomonee FallsUnited StatesRecruiting
UH Seidman Cancer Center at Lake Health Mentor Campus
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MentorUnited StatesRecruiting
Medical College of Wisconsin
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MilwaukeeUnited StatesRecruiting
Palo Alto Medical Foundation-Camino Division
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Mountain ViewUnited StatesRecruiting
ProHealth D N Greenwald Center
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MukwonagoUnited StatesRecruiting
Medical Oncology Hematology Consultants PA
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NewarkUnited StatesRecruiting
Christiana Care Health System-Christiana Hospital
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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
Yale University
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New HavenUnited StatesRecruiting
Smilow Cancer Center/Yale-New Haven Hospital
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New HavenUnited StatesRecruiting
UC Comprehensive Cancer Center at Silver Cross
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New LenoxUnited StatesRecruiting
Mount Sinai Hospital
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New YorkUnited StatesRecruiting
Yale-New Haven Hospital North Haven Medical Center
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North HavenUnited StatesRecruiting
Henry Ford Medical Center-Columbus
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NoviUnited StatesRecruiting
Drexel Town Square Health Center
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Oak CreekUnited StatesRecruiting
ProHealth Oconomowoc Memorial Hospital
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OconomowocUnited StatesRecruiting
University of Nebraska Medical Center
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OmahaUnited StatesRecruiting
Nebraska Medicine-Village Pointe
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OmahaUnited StatesRecruiting
UC Irvine Health- Chao Family Comprehensive Cancer Center
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OrangeUnited StatesRecruiting
Providence Willamette Falls Medical Center
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Oregon CityUnited StatesRecruiting
University of Chicago Medicine-Orland Park
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Orland ParkUnited StatesRecruiting
Palo Alto Medical Foundation Health Care
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Palo AltoUnited StatesRecruiting
Providence Saint Vincent Medical Center
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PortlandUnited StatesRecruiting
Providence Portland Medical Center
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PortlandUnited StatesRecruiting
Duke Cancer Center Raleigh
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RaleighUnited StatesRecruiting
Marshfield Medical Center-Rice Lake
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Rice LakeUnited StatesRecruiting
Sutter Cancer Centers Radiation Oncology Services-Roseville
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RosevilleUnited StatesRecruiting
Sutter Roseville Medical Center
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RosevilleUnited StatesRecruiting
Sutter Medical Center Sacramento
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SacramentoUnited StatesRecruiting
University of California Davis Comprehensive Cancer Center
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SacramentoUnited StatesRecruiting
Essentia Health Sandstone
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SandstoneUnited StatesRecruiting
California Pacific Medical Center-Pacific Campus
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San FranciscoUnited StatesRecruiting
Sutter Pacific Medical Foundation
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Santa RosaUnited StatesRecruiting
Memorial Hospital East
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ShilohUnited StatesRecruiting
Essentia Health-Spooner Clinic
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SpoonerUnited StatesRecruiting
Smilow Cancer Hospital Care Center at Long Ridge
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StamfordUnited StatesRecruiting
Marshfield Medical Center-River Region at Stevens Point
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Stevens PointUnited StatesRecruiting
Siteman Cancer Center at Christian Hospital
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St LouisUnited StatesRecruiting
Washington University School of Medicine
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St LouisUnited StatesRecruiting
Siteman Cancer Center-South County
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St LouisUnited StatesRecruiting
Palo Alto Medical Foundation-Sunnyvale
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SunnyvaleUnited StatesRecruiting
Essentia Health Saint Mary's Hospital - Superior
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SuperiorUnited 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
Smilow Cancer Hospital-Torrington Care Center
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TorringtonUnited StatesRecruiting
Smilow Cancer Hospital Care Center-Trumbull
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TrumbullUnited StatesRecruiting
Carle Cancer Center
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UrbanaUnited StatesRecruiting
Essentia Health Virginia Clinic
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VirginiaUnited 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
UI Health Care Mission Cancer and Blood - Waukee Clinic
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WaukeeUnited StatesRecruiting
UW Cancer Center at ProHealth Care
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WaukeshaUnited StatesRecruiting
Froedtert West Bend Hospital/Kraemer Cancer Center
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West BendUnited StatesRecruiting
Henry Ford West Bloomfield Hospital
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West BloomfieldUnited StatesRecruiting
The Iowa Clinic PC
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West Des MoinesUnited StatesRecruiting
Mercy Medical Center-West Lakes
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West Des MoinesUnited StatesRecruiting
Marshfield Medical Center - Weston
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WestonUnited 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
Henry Ford Wyandotte Hospital
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WyandotteUnited StatesRecruiting

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