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NCT05235165RecruitingPhase 3

Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma

A Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma

Source: ClinicalTrials.gov · Last updated 25 Aug 2026

Brief summary (registry, in English)

This phase III trial compares the effect of open thoracic surgery (thoracotomy) to thoracoscopic surgery (video-assisted thoracoscopic surgery or VATS) in treating patients with osteosarcoma that has spread to the lung (pulmonary metastases). Open thoracic surgery is a type of surgery done through a single larger incision (like a large cut) that goes between the ribs, opens up the chest, and removes the cancer. Thoracoscopy is a type of chest surgery where the doctor makes several small incisions and uses a small camera to help with removing the cancer. This trial is being done evaluate the two different surgery methods for patients with osteosarcoma that has spread to the lung to find out which is better.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
62 (estimated)
First submitted
19 Jan 2022
Start date
1 Apr 2022
Primary completion date
31 Mar 2031
Lead sponsor
Children's Oncology Group
NCT number
NCT05235165

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 62
  • From 1 Apr 2022 to the primary completion date, 31 Mar 2031
  • 233 sites in 6 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.

Prior treatment

  • Patients with pulmonary metastatic lesions that would require anatomic resection (lobectomy or pneumonectomy) or lesions that are defined as "central" (i.e., central lesion involves or is proximal to segmental bronchi and peripheral is lesion distal to segmental bronchi).
  • Patients with disease progression at either the primary or pulmonary metastatic site while on initial therapy. Note: Once the patient has been enrolled on the study, additional computed tomography (CT) scans are not anticipated prior to thoracic surgery. Note: Some variation in nodule size measurements over the course of pre-operative therapy is anticipated and does not qualify for exclusion unless deemed true disease progression by the primary treatment team.
  • Patients who received therapeutic pulmonary surgery for lung metastasis prior to enrollment.

Other illness

  • Patients with evidence of extrapulmonary metastatic disease.
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.

Other

  • Patients with unresectable primary tumor.
  • Patients with chest wall or mediastinal based metastatic lesions, or with significant pleural effusion.
  • All patients and/or their parents or legal guardians must sign a written informed consent.

Who the study is looking for

  • Patients must be \< 50 years at the time of enrollment.
  • Patients must have =\< 4 nodules per lung consistent with or suspicious for metastases, with at least one of which being \>= 3 mm and all of which must be =\< 3 cm size.
    • Note: Patient must have eligibility confirmed by rapid central imaging review.
  • Lung nodules must be considered resectable by either open thoracotomy or thoracoscopic surgery. Determination of resectability is made by the institutional surgeon.
  • Patients must have a histological diagnosis of osteosarcoma.
  • Patients must have evidence of metastatic lung disease at the time of initial diagnosis, or at time of 1st recurrence following completion of therapy for initially localized disease.
  • Patients with newly diagnosed disease must have completed successful gross tumor resection for their primary tumor or surgical local control of primary tumor must be planned to be performed simultaneously with thoracic surgery.
  • Newly diagnosed patients must be receiving or recently completed (within 60 days) systemic therapy considered by the treating physician to be standard treatment for newly diagnosed osteosarcoma (eg, cisplatin-doxorubicin or ifosfamide-based drug regimens) at the time of enrollment on this study. Dose and drug modifications for toxicity do not exclude patients from participation.
  • Patients at time of 1st recurrence must have completed systemic therapy for their initial primary tumor, considered by the treating physician to be standard treatment for newly diagnosed osteosarcoma (eg, cisplatin-doxorubicin or ifosfamide-based drug regimens) at the time of enrollment on this study. Dose and drug modifications for toxicity do not exclude patients from participation.

Age in the registry: - to 50 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (233)

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

SiteCityCountrySite status
Royal Children's Hospital
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ParkvilleAustraliaSuspended
Perth Children's Hospital
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PerthAustraliaSuspended
The Children's Hospital at Westmead
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WestmeadAustraliaSuspended
Alberta Children's Hospital
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CalgaryCanadaRecruiting
University of Alberta Hospital
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EdmontonCanadaRecruiting
IWK Health Centre
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HalifaxCanadaRecruiting
The Montreal Children's Hospital of the MUHC
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MontrealCanadaRecruiting
Centre Hospitalier Universitaire Sainte-Justine
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MontrealCanadaRecruiting
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
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SherbrookeCanadaRecruiting
Christchurch Hospital
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ChristchurchNew ZealandRecruiting
Starship Children's Hospital
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GraftonNew ZealandRecruiting
HIMA San Pablo Oncologic Hospital
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CaguasPuerto RicoActive, not recruiting
King Faisal Specialist Hospital and Research Centre
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RiyadhSaudi ArabiaSuspended
Children's Hospital Medical Center of Akron
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AkronUnited StatesRecruiting
Albany Medical Center
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AlbanyUnited StatesRecruiting
Presbyterian Hospital
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AlbuquerqueUnited StatesRecruiting
Lehigh Valley Hospital-Cedar Crest
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AllentownUnited StatesRecruiting
Texas Tech University Health Sciences Center-Amarillo
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AmarilloUnited StatesActive, not recruiting
Kaiser Permanente-Anaheim
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AnaheimUnited StatesRecruiting
Providence Alaska Medical Center
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AnchorageUnited StatesRecruiting
C S Mott Children's Hospital
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Ann ArborUnited StatesRecruiting
University of Michigan Rogel Cancer Center
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Ann ArborUnited StatesRecruiting
PCR Oncology
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Arroyo GrandeUnited StatesRecruiting
Mission Hospital
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AshevilleUnited StatesRecruiting
Children's Healthcare of Atlanta - Arthur M Blank Hospital
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AtlantaUnited StatesRecruiting
Children's Hospital Colorado
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AuroraUnited StatesRecruiting
Dell Children's Medical Center of Central Texas
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AustinUnited StatesRecruiting
Johns Hopkins University/Sidney Kimmel Cancer Center
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BaltimoreUnited StatesRecruiting
Sinai Hospital of Baltimore
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BaltimoreUnited StatesRecruiting
University of Maryland/Greenebaum Cancer Center
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BaltimoreUnited StatesRecruiting
Eastern Maine Medical Center
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BangorUnited StatesRecruiting
Bronson Battle Creek
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Battle CreekUnited StatesRecruiting
Overlake Medical Center
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BellevueUnited StatesSuspended
Kaiser Permanente-Bellflower
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BellflowerUnited StatesRecruiting
Walter Reed National Military Medical Center
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BethesdaUnited StatesRecruiting
Children's Hospital of Alabama
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BirminghamUnited StatesRecruiting
Saint Luke's Cancer Institute - Boise
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BoiseUnited StatesRecruiting
Dana-Farber Cancer Institute
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BostonUnited StatesRecruiting
Massachusetts General Hospital Cancer Center
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BostonUnited StatesRecruiting
Maimonides Medical Center
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BrooklynUnited StatesRecruiting
University of Vermont and State Agricultural College
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BurlingtonUnited StatesActive, not recruiting
Carson Tahoe Regional Medical Center
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Carson CityUnited StatesRecruiting
UNC Lineberger Comprehensive Cancer Center
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Chapel HillUnited StatesRecruiting
Medical University of South Carolina
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CharlestonUnited StatesRecruiting
University of Virginia Cancer Center
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CharlottesvilleUnited StatesRecruiting
Lurie Children's Hospital-Chicago
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ChicagoUnited StatesRecruiting
University of Chicago Comprehensive Cancer Center
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ChicagoUnited StatesRecruiting
University of Illinois
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ChicagoUnited StatesRecruiting
Cincinnati Children's Hospital Medical Center
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CincinnatiUnited StatesRecruiting
Cleveland Clinic Foundation
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ClevelandUnited StatesRecruiting
Rainbow Babies and Childrens Hospital
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ClevelandUnited StatesRecruiting
Prisma Health Richland Hospital
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ColumbiaUnited StatesRecruiting
University of Missouri Children's Hospital
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ColumbiaUnited StatesRecruiting
Nationwide Children's Hospital
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ColumbusUnited StatesRecruiting
Driscoll Children's Hospital
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Corpus ChristiUnited StatesRecruiting
UT Southwestern/Simmons Cancer Center-Dallas
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DallasUnited StatesRecruiting
Medical City Dallas Hospital
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DallasUnited StatesRecruiting
Geisinger Medical Center
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DanvilleUnited StatesRecruiting
Dayton Children's Hospital
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DaytonUnited StatesRecruiting
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
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DenverUnited StatesRecruiting
Blank Children's Hospital
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Des MoinesUnited StatesRecruiting
Children's Hospital of Michigan
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DetroitUnited StatesRecruiting
Kaiser Permanente Downey Medical Center
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DowneyUnited StatesRecruiting
Duke University Medical Center
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DurhamUnited StatesRecruiting
Michigan State University
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East LansingUnited StatesSuspended
El Paso Children's Hospital
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El PasoUnited StatesRecruiting
Inova Fairfax Hospital
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Falls ChurchUnited StatesRecruiting
Sanford Broadway Medical Center
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FargoUnited StatesRecruiting
Kaiser Permanente-Fontana
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FontanaUnited StatesRecruiting
Golisano Children's Hospital of Southwest Florida
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Fort MyersUnited StatesRecruiting
Cook Children's Medical Center
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Fort WorthUnited StatesRecruiting
UF Health Cancer Institute - Gainesville
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GainesvilleUnited StatesActive, not recruiting
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
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Grand RapidsUnited StatesRecruiting
Trinity Health Grand Rapids Hospital
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Grand RapidsUnited StatesRecruiting
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
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Grand RapidsUnited StatesRecruiting
BI-LO Charities Children's Cancer Center
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GreenvilleUnited StatesRecruiting
East Carolina University
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GreenvilleUnited StatesRecruiting
Hackensack University Medical Center
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HackensackUnited StatesRecruiting
Connecticut Children's Medical Center
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HartfordUnited StatesRecruiting
Oncology Las Vegas - Henderson
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HendersonUnited StatesRecruiting
Comprehensive Cancer Centers of Nevada-Southeast Henderson
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HendersonUnited StatesRecruiting
Las Vegas Urology - Pebble
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HendersonUnited StatesSuspended
Las Vegas Urology - Green Valley
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HendersonUnited StatesSuspended
Comprehensive Cancer Centers of Nevada - Henderson
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HendersonUnited StatesRecruiting
Las Vegas Cancer Center-Henderson
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HendersonUnited StatesSuspended
Comprehensive Cancer Centers of Nevada-Horizon Ridge
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HendersonUnited StatesRecruiting
Urology Specialists of Nevada - Green Valley
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HendersonUnited StatesRecruiting
Penn State Children's Hospital
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HersheyUnited StatesRecruiting
Kapiolani Medical Center for Women and Children
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HonoluluUnited StatesRecruiting
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
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HoustonUnited StatesRecruiting
UT MD Anderson Cancer Center
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HoustonUnited StatesRecruiting
Riley Hospital for Children
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IndianapolisUnited StatesRecruiting
University of Iowa/Holden Comprehensive Cancer Center
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Iowa CityUnited StatesRecruiting
University of Mississippi Medical Center
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JacksonUnited StatesRecruiting
Nemours Children's Clinic-Jacksonville
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JacksonvilleUnited StatesRecruiting
Beacon Kalamazoo Cancer Center
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KalamazooUnited StatesRecruiting
Beacon Kalamazoo
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KalamazooUnited StatesRecruiting
Bronson Methodist Hospital
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KalamazooUnited StatesRecruiting
West Michigan Cancer Center
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KalamazooUnited StatesRecruiting
Children's Mercy Hospitals and Clinics
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Kansas CityUnited StatesRecruiting
Kingman Regional Medical Center
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KingmanUnited StatesRecruiting
East Tennessee Childrens Hospital
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KnoxvilleUnited StatesRecruiting
Las Vegas Urology - Smoke Ranch
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Las VegasUnited StatesSuspended
Radiation Oncology Centers of Nevada Central
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Las VegasUnited StatesRecruiting
Comprehensive Cancer Centers of Nevada-Summerlin
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Las VegasUnited StatesRecruiting
Comprehensive Cancer Centers of Nevada - Central Valley
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Las VegasUnited StatesRecruiting
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
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Las VegasUnited StatesRecruiting
Las Vegas Urology - Sunset
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Las VegasUnited StatesSuspended
Urology Specialists of Nevada - Southwest
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Las VegasUnited StatesRecruiting
OptumCare Cancer Care at Charleston
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Las VegasUnited StatesRecruiting
Urology Specialists of Nevada - Northwest
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Las VegasUnited StatesRecruiting
OptumCare Cancer Care at MountainView
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Las VegasUnited StatesRecruiting
Comprehensive Cancer Centers of Nevada - Town Center
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Las VegasUnited StatesRecruiting
Las Vegas Cancer Center-Medical Center
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Las VegasUnited StatesSuspended
Comprehensive Cancer Centers of Nevada - Northwest
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Las VegasUnited StatesRecruiting
Hope Cancer Care of Nevada
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Las VegasUnited StatesRecruiting
Ann M Wierman MD LTD
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Las VegasUnited StatesSuspended
University Medical Center of Southern Nevada
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Las VegasUnited StatesRecruiting
Comprehensive Cancer Centers of Nevada
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Las VegasUnited StatesRecruiting
Radiation Oncology Centers of Nevada Southeast
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Las VegasUnited StatesRecruiting
Urology Specialists of Nevada - Central
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Las VegasUnited StatesRecruiting
Sunrise Hospital and Medical Center
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Las VegasUnited StatesRecruiting
OptumCare Cancer Care at Fort Apache
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Las VegasUnited StatesRecruiting
Las Vegas Urology - Cathedral Rock
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Las VegasUnited StatesSuspended
Oncology Las Vegas - Tenaya
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Las VegasUnited StatesRecruiting
Summerlin Hospital Medical Center
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Las VegasUnited StatesRecruiting
Las Vegas Urology - Pecos
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Las VegasUnited StatesSuspended
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
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LebanonUnited StatesRecruiting
University of Kentucky/Markey Cancer Center
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LexingtonUnited StatesRecruiting
Arkansas Children's Hospital
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Little RockUnited StatesRecruiting
Loma Linda University Medical Center
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Loma LindaUnited StatesRecruiting
Miller Children's and Women's Hospital Long Beach
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Long BeachUnited StatesRecruiting
Children's Hospital Los Angeles
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Los AngelesUnited StatesRecruiting
Cedars-Sinai Medical Center
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Los AngelesUnited StatesRecruiting
Kaiser Permanente Los Angeles Medical Center
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Los AngelesUnited StatesRecruiting
Norton Children's Hospital
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LouisvilleUnited StatesRecruiting
Valley Children's Hospital
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MaderaUnited StatesRecruiting
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
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MadisonUnited StatesRecruiting
University of Wisconsin Carbone Cancer Center - University Hospital
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MadisonUnited StatesRecruiting
Marshfield Medical Center-Marshfield
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MarshfieldUnited StatesRecruiting
Loyola University Medical Center
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MaywoodUnited StatesRecruiting
Saint Jude Children's Research Hospital
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MemphisUnited StatesRecruiting
Banner Children's at Desert
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MesaUnited StatesRecruiting
Nicklaus Children's Hospital
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MiamiUnited StatesRecruiting
Children's Hospital of Wisconsin
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MilwaukeeUnited StatesRecruiting
University of Minnesota/Masonic Cancer Center
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MinneapolisUnited StatesRecruiting
Children's Hospitals and Clinics of Minnesota - Minneapolis
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MinneapolisUnited StatesRecruiting
West Virginia University Healthcare
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MorgantownUnited StatesRecruiting
Morristown Medical Center
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MorristownUnited StatesRecruiting
Trinity Health Muskegon Hospital
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MuskegonUnited StatesRecruiting
Vanderbilt University/Ingram Cancer Center
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NashvilleUnited StatesRecruiting
The Children's Hospital at TriStar Centennial
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NashvilleUnited StatesRecruiting
Saint Peter's University Hospital
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New BrunswickUnited StatesRecruiting
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
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New BrunswickUnited StatesRecruiting
Yale University
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New HavenUnited StatesRecruiting
Smilow Cancer Center/Yale-New Haven Hospital
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New HavenUnited StatesRecruiting
The Steven and Alexandra Cohen Children's Medical Center of New York
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New Hyde ParkUnited StatesRecruiting
Ochsner Medical Center Jefferson
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New OrleansUnited StatesRecruiting
Children's Hospital New Orleans
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New OrleansUnited StatesRecruiting
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
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New YorkUnited StatesRecruiting
Mount Sinai Hospital
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New YorkUnited StatesRecruiting
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesRecruiting
Laura and Isaac Perlmutter Cancer Center at NYU Langone
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New YorkUnited StatesRecruiting
Corewell Health Lakeland Hospitals - Niles Hospital
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NilesUnited StatesRecruiting
Children's Hospital of The King's Daughters
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NorfolkUnited StatesRecruiting
Cancer and Hematology Centers of Western Michigan - Norton Shores
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Norton ShoresUnited StatesSuspended
Kaiser Permanente-Oakland
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OaklandUnited StatesRecruiting
University of Oklahoma Health Sciences Center
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Oklahoma CityUnited StatesRecruiting
University of Nebraska Medical Center
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OmahaUnited StatesRecruiting
Children's Hospital and Medical Center of Omaha
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OmahaUnited StatesRecruiting
Children's Hospital of Orange County
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OrangeUnited StatesRecruiting
Nemours Children's Hospital
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OrlandoUnited StatesRecruiting
Arnold Palmer Hospital for Children
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OrlandoUnited StatesRecruiting
Hope Cancer Care of Nevada-Pahrump
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PahrumpUnited StatesRecruiting
Lucile Packard Children's Hospital Stanford University
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Palo AltoUnited StatesRecruiting
Saint Joseph's Regional Medical Center
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PatersonUnited StatesRecruiting
OSF Children's Hospital of Illinois
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PeoriaUnited StatesRecruiting
Saint Christopher's Hospital for Children
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PhiladelphiaUnited StatesRecruiting
Phoenix Childrens Hospital
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PhoenixUnited StatesRecruiting
Children's Hospital of Pittsburgh of UPMC
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PittsburghUnited StatesRecruiting
Oregon Health and Science University
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PortlandUnited StatesRecruiting
Legacy Emanuel Children's Hospital
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PortlandUnited StatesRecruiting
Rhode Island Hospital
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ProvidenceUnited StatesRecruiting
Corewell Health Reed City Hospital
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Reed CityUnited StatesRecruiting
Northern Nevada Radiation Oncology
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RenoUnited StatesSuspended
Radiation Oncology Associates
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RenoUnited StatesSuspended
Renown Regional Medical Center
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RenoUnited StatesRecruiting
Saint Mary's Regional Medical Center
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RenoUnited StatesRecruiting
Valley Medical Center
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RentonUnited 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
Carilion Children's
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RoanokeUnited StatesRecruiting
Mayo Clinic in Rochester
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RochesterUnited StatesRecruiting
Corewell Health Children's
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Royal OakUnited StatesRecruiting
University of California Davis Comprehensive Cancer Center
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SacramentoUnited StatesRecruiting
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
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Saint JosephUnited StatesRecruiting
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
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Saint JosephUnited StatesRecruiting
Primary Children's Hospital
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Salt Lake CityUnited StatesRecruiting
University of Texas Health Science Center at San Antonio
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San AntonioUnited StatesRecruiting
Children's Hospital of San Antonio
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San AntonioUnited StatesRecruiting
Methodist Children's Hospital of South Texas
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San AntonioUnited StatesRecruiting
Kaiser Permanente-San Diego Zion
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San DiegoUnited StatesRecruiting
Rady Children's Hospital - San Diego
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San DiegoUnited StatesRecruiting
UCSF Medical Center-Mission Bay
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San FranciscoUnited StatesRecruiting
Maine Children's Cancer Program
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ScarboroughUnited StatesRecruiting
Seattle Children's Hospital
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SeattleUnited StatesRecruiting
Sanford USD Medical Center - Sioux Falls
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Sioux FallsUnited StatesRecruiting
Providence Sacred Heart Medical Center and Children's Hospital
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SpokaneUnited StatesRecruiting
Cardinal Glennon Children's Medical Center
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St LouisUnited StatesRecruiting
Washington University School of Medicine
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St LouisUnited StatesRecruiting
Mercy Hospital Saint Louis
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St LouisUnited StatesRecruiting
Stony Brook University Medical Center
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Stony BrookUnited StatesRecruiting
Johns Hopkins All Children's Hospital
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St. PetersburgUnited StatesRecruiting
State University of New York Upstate Medical University
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SyracuseUnited StatesRecruiting
Madigan Army Medical Center
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TacomaUnited StatesRecruiting
Mary Bridge Children's Hospital and Health Center
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TacomaUnited StatesRecruiting
Saint Joseph's Hospital/Children's Hospital-Tampa
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TampaUnited StatesRecruiting
Tampa General Hospital
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TampaUnited StatesRecruiting
Montefiore Medical Center-Weiler Hospital
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The BronxUnited StatesRecruiting
Montefiore Medical Center - Moses Campus
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The BronxUnited StatesRecruiting
Children's Hospital at Montefiore
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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
Munson Medical Center
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Traverse CityUnited StatesRecruiting
Banner University Medical Center - Tucson
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TucsonUnited StatesRecruiting
New York Medical College
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ValhallaUnited StatesRecruiting
Westchester Medical Center
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ValhallaUnited StatesSuspended
Children's National Medical Center
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Washington D.C.United StatesRecruiting
Alfred I duPont Hospital for Children
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WilmingtonUnited StatesRecruiting
Northwestern Medicine Central DuPage Hospital
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WinfieldUnited StatesRecruiting
Wake Forest University Health Sciences
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Winston-SalemUnited StatesRecruiting
University of Michigan Health - West
Coordinator of this site? Confirm its status
WyomingUnited StatesRecruiting
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
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YakimaUnited StatesRecruiting

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