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NCT07293247RecruitingPhase 2

A Study of Targeted Post-Surgery Radiation Therapy for Non-Small Cell Lung Cancer With Remaining Lymph Node Cancer After Treatment

Involved-Station, Intensity-Modulated Post-Operative Radiation Therapy (I²-PORT) for Resected Non-Small Cell Lung Cancer With Residual Mediastinal Adenopathy After Neoadjuvant Therapy (ypN2)

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

This phase II trial compares the effect of intensity-modulated post-operative radiation therapy (I²-PORT) followed by standard of care therapy (chemotherapy or immunotherapy) to standard of care therapy alone in treating patients with non-small cell lung cancer (NSCLC) who have remaining lymph node cancer after surgery. Radiation therapy uses high-energy X-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. 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. Chemotherapy drugs 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. Immunotherapy may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Adding I²-PORT radiation therapy to standard therapy may be more effective than standard therapy alone in reducing the risk of cancer returning in those who have undergone surgery for NSCLC.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
164 (estimated)
First submitted
17 Dec 2025
Start date
14 Oct 2026
Primary completion date
31 Dec 2032
Lead sponsor
Alliance for Clinical Trials in Oncology
Diseases
Lung cancer
NCT number
NCT07293247

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 164
  • From 14 Oct 2026 to the primary completion date, 31 Dec 2032
  • 125 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.

Criteria the registry did not label

  • Histopathologic diagnosis of NSCLC, may have mixed or multiple histologies but no small cell component
  • No known EGFR mutation or ALK rearrangement
  • No metastatic disease (M0) per most recent PET/CT and head CT/MRI imaging
  • No disease progression per CT chest (including upper abdomen as per standard practice) with intravenous (IV) contrast (unless IV contrast is contraindicated) or FDG-PET performed post-neoadjuvant therapy ≤ 90 days prior to registration, either before or after surgery
  • No metastatic disease (M0) per head CT/MRI imaging
  • Prior treatment with 2-4 cycles of neoadjuvant systemic therapy with any guideline (National Comprehensive Cancer Network \[NCCN\]) concordant regimen
  • Lobectomy or greater oncologic surgical resection within 8 weeks prior to registration
  • Complete (R0) resection showing ypN2 disease
  • No prior radiotherapy to the lungs or mediastinum
  • No treatment with a VEGF inhibitor ≤ 90 days prior to registration or plan to treat with adjuvant systemic therapy including a VEGF inhibitor
  • Age ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Absolute neutrophil count (ANC) ≥ 1,000/mm\^3
  • Platelet count ≥ 50,000/mm\^3
  • Calculated (Calc.) creatinine clearance ≥ 30 mL/min
  • Total bilirubin ≤ 3 x upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 5 x upper limit of normal (ULN)
  • Not pregnant, because this study involves radiation therapy, which has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative urine or serum pregnancy test done ≤ 7 days prior to registration is required
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  • Cardiac function: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
  • No idiopathic pulmonary fibrosis requiring anti-fibrotic medication: Patients with idiopathic pulmonary fibrosis or inflammatory/interstitial lung disease compromising pulmonary function or requiring ongoing treatment with nintedanib, pirfenidone, or other anti-fibrotic drug are excluded
  • HIV-infected patients on effective anti-retroviral therapy with an undetectable viral load within 6 months are eligible for this trial

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

Full criteria on ClinicalTrials.gov

Sites (125)

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

SiteCityCountrySite status
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
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Ann ArborUnited StatesRecruiting
Northwest Wisconsin Cancer Center
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AshlandUnited StatesRecruiting
Duluth Clinic Ashland
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AshlandUnited StatesRecruiting
Mount Sinai Comprehensive Cancer Center at Aventura
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AventuraUnited StatesRecruiting
Memorial Sloan Kettering Basking Ridge
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Basking RidgeUnited StatesRecruiting
MaineHealth Coastal Cancer Treatment Center
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BathUnited StatesRecruiting
UPMC-Heritage Valley Health System Beaver
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BeaverUnited StatesRecruiting
Sanford Joe Lueken Cancer Center
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BemidjiUnited StatesRecruiting
Sanford Bismarck Medical Center
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BismarckUnited StatesRecruiting
Illinois CancerCare-Bloomington
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BloomingtonUnited StatesRecruiting
OSF Saint Joseph Medical Center
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BloomingtonUnited StatesRecruiting
Essentia Health Saint Joseph's Medical Center
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BrainerdUnited StatesRecruiting
Trinity Health Medical Center - Brighton
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BrightonUnited StatesRecruiting
Trinity Health IHA Medical Group Hematology Oncology - Brighton
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BrightonUnited StatesRecruiting
MaineHealth Cancer Care and IV Therapy - Brunswick
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BrunswickUnited StatesRecruiting
Trinity Health Medical Center - Canton
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CantonUnited StatesRecruiting
Illinois CancerCare-Canton
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CantonUnited StatesRecruiting
Trinity Health IHA Medical Group Hematology Oncology - Canton
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CantonUnited StatesRecruiting
Saint Francis Medical Center
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Cape GirardeauUnited StatesRecruiting
Carlisle Regional Cancer Center
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CarlisleUnited StatesRecruiting
Illinois CancerCare-Carthage
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CarthageUnited StatesRecruiting
UNC Lineberger Comprehensive Cancer Center
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Chapel HillUnited 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
Rush MD Anderson Cancer Center
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ChicagoUnited StatesRecruiting
Clackamas Radiation Oncology Center
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ClackamasUnited StatesRecruiting
Baptist Memorial Hospital and Cancer Center-Collierville
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ColliervilleUnited StatesRecruiting
Ohio State University Comprehensive Cancer Center
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ColumbusUnited StatesRecruiting
Memorial Sloan Kettering Commack
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CommackUnited StatesRecruiting
Cancer Care Specialists of Illinois - Decatur
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DecaturUnited StatesRecruiting
Decatur Memorial Hospital
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DecaturUnited StatesRecruiting
Essentia Health - Deer River Clinic
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Deer RiverUnited StatesRecruiting
Miller-Dwan Hospital
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DuluthUnited StatesRecruiting
Essentia Health Saint Mary's Medical Center
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DuluthUnited StatesRecruiting
Essentia Health Cancer Center
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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
UPMC Hillman Cancer Center Erie
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ErieUnited StatesRecruiting
Illinois CancerCare-Eureka
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EurekaUnited StatesRecruiting
Sanford Broadway Medical Center
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FargoUnited StatesRecruiting
Sanford Roger Maris Cancer Center
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FargoUnited StatesRecruiting
Parkland Health Center - Farmington
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FarmingtonUnited StatesSuspended
UPMC Cancer Center at UPMC Horizon
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FarrellUnited StatesRecruiting
Illinois CancerCare-Galesburg
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GalesburgUnited StatesRecruiting
UPMC Cancer Centers - Arnold Palmer Pavilion
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GreensburgUnited StatesRecruiting
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
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HarrisburgUnited StatesRecruiting
Memorial Sloan Kettering Westchester
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HarrisonUnited StatesRecruiting
Essentia Health-Hayward Clinic
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HaywardUnited StatesRecruiting
Essentia Health Hibbing Clinic
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HibbingUnited StatesRecruiting
IRMC Cancer Center
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IndianaUnited StatesRecruiting
Baptist MD Anderson Cancer Center
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JacksonvilleUnited StatesRecruiting
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
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JonesboroUnited StatesRecruiting
Bronson Methodist Hospital
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KalamazooUnited StatesRecruiting
West Michigan Cancer Center
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KalamazooUnited StatesRecruiting
Beacon Kalamazoo
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KalamazooUnited StatesRecruiting
Illinois CancerCare-Kewanee Clinic
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KewaneeUnited StatesRecruiting
Trinity Health Saint Mary Mercy Livonia Hospital
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LivoniaUnited StatesRecruiting
USC / Norris Comprehensive Cancer Center
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Los AngelesUnited StatesRecruiting
Illinois CancerCare-Macomb
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MacombUnited StatesRecruiting
Marshfield Medical Center-Marshfield
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MarshfieldUnited StatesRecruiting
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
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MechanicsburgUnited StatesRecruiting
Baptist Memorial Hospital and Cancer Center-Memphis
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MemphisUnited StatesRecruiting
Mount Sinai Medical Center
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Miami BeachUnited StatesRecruiting
Memorial Sloan Kettering Monmouth
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MiddletownUnited StatesRecruiting
UPMC Hillman Cancer Center - Monroeville
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MonroevilleUnited StatesRecruiting
UPMC Cancer Center - Monroeville
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MonroevilleUnited StatesRecruiting
Memorial Sloan Kettering Bergen
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MontvaleUnited StatesRecruiting
Providence Newberg Medical Center
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NewbergUnited StatesRecruiting
UPMC Hillman Cancer Center - New Castle
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New CastleUnited StatesRecruiting
New York Proton Center
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New YorkUnited StatesRecruiting
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesRecruiting
Arnold Palmer Cancer Center Medical Oncology Norwin
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N. HuntingdonUnited StatesRecruiting
HSHS Saint Elizabeth's Hospital
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O'FallonUnited StatesRecruiting
Cancer Care Center of O'Fallon
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O'FallonUnited StatesRecruiting
Providence Willamette Falls Medical Center
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Oregon CityUnited StatesRecruiting
Upstate Cancer Center Radiation Oncology at Oswego
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OswegoUnited StatesRecruiting
Upstate Cancer Center at Oswego
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OswegoUnited StatesRecruiting
Illinois CancerCare-Ottawa Clinic
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OttawaUnited StatesRecruiting
Baptist Memorial Hospital and Cancer Center-Oxford
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OxfordUnited StatesRecruiting
AdventHealth Parker
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ParkerUnited StatesRecruiting
OSF Saint Francis Radiation Oncology at Pekin
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PekinUnited StatesRecruiting
Illinois CancerCare-Pekin
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PekinUnited StatesRecruiting
Illinois CancerCare-Peoria
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PeoriaUnited 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-Peru
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PeruUnited StatesRecruiting
UPMC-Saint Margaret
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PittsburghUnited StatesRecruiting
UPMC Hillman Cancer Center
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PittsburghUnited StatesRecruiting
UPMC-Saint Clair Hospital Cancer Center
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PittsburghUnited StatesRecruiting
UPMC-Shadyside Hospital
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PittsburghUnited StatesRecruiting
UPMC-Passavant Hospital
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PittsburghUnited StatesRecruiting
Providence Saint Vincent Medical Center
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PortlandUnited StatesRecruiting
Providence Portland Medical Center
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PortlandUnited StatesRecruiting
MaineHealth Maine Medical Center - Portland
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PortlandUnited StatesRecruiting
Illinois CancerCare-Princeton
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PrincetonUnited StatesRecruiting
Marshfield Medical Center-Rice Lake
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Rice LakeUnited StatesRecruiting
Sainte Genevieve County Memorial Hospital
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Sainte GenevieveUnited StatesSuspended
Essentia Health Sandstone
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SandstoneUnited StatesRecruiting
MaineHealth Cancer Care Center of York County
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SanfordUnited StatesRecruiting
MaineHealth Maine Medical Center- Scarborough
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ScarboroughUnited StatesRecruiting
UPMC Cancer Center at UPMC Northwest
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SenecaUnited 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
Baptist Memorial Hospital and Cancer Center-Desoto
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SouthhavenUnited StatesRecruiting
MaineHealth Cancer Care and IV Therapy - South Portland
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South PortlandUnited StatesRecruiting
Essentia Health-Spooner Clinic
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SpoonerUnited StatesRecruiting
Marshfield Medical Center-River Region at Stevens Point
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Stevens PointUnited StatesRecruiting
Missouri Baptist Medical Center
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St LouisUnited StatesSuspended
Missouri Baptist Sullivan Hospital
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SullivanUnited StatesSuspended
Essentia Health Saint Mary's Hospital - Superior
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SuperiorUnited StatesRecruiting
Upstate Cancer Center at Hill Radiation Oncology
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SyracuseUnited StatesRecruiting
State University of New York Upstate Medical University
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SyracuseUnited 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
Munson Medical Center
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Traverse CityUnited StatesRecruiting
Memorial Sloan Kettering Nassau
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UniondaleUnited StatesRecruiting
Upstate Cancer Center at Verona
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VeronaUnited StatesRecruiting
Essentia Health Virginia Clinic
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VirginiaUnited StatesRecruiting
UPMC Cancer Center-Washington
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WashingtonUnited StatesRecruiting
Illinois CancerCare - Washington
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WashingtonUnited StatesRecruiting
UPMC Washington Hospital Radiation Oncology
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WashingtonUnited StatesRecruiting
Marshfield Medical Center - Weston
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WestonUnited StatesRecruiting
Ascension Via Christi Hospitals Wichita
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WichitaUnited 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.