Metastatic Malignant Neoplasm in the LungPhase 3NCT05235165
Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma
A Phase 3 study testing Biospecimen Collection, Computed Tomography and Questionnaire Administration in people with Metastatic Malignant Neoplasm in the Lung and Metastatic Osteosarcoma, run by Children's Oncology Group at 233 sites in 6 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages Up to 50 years
- Conditions the study is for
- Metastatic Malignant Neoplasm in the Lung, Metastatic Osteosarcoma, Osteosarcoma
- What is being tested?
- Biospecimen Collection, Computed Tomography and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 233 sitesin 6 countries
- Study dates
- 1 Apr 2022to 31 Mar 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- Patients with unresectable primary tumor.
- 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 chest wall or mediastinal based metastatic lesions, or with significant pleural effusion.
- 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 with evidence of extrapulmonary metastatic disease.
- Patients who received therapeutic pulmonary surgery for lung metastasis prior to enrollment.
- All patients and/or their parents or legal guardians must sign a written informed consent.
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.
Trial locations and contacts
233 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
233 sites in 6 countries
United States220 sites, 202 recruiting
- Recruiting
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308
Site Public Contact, 330-543-3193
Erin Wright
- Recruiting
Albany Medical Center
Albany, New York, 12208
Site Public Contact, 518-262-5513
Lauren R. Weintraub
- Recruiting
Presbyterian Hospital
Albuquerque, New Mexico, 87106
Site Public Contact, 505-559-6113, wburman@phs.org
Beeling Armijo
- Recruiting
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Jacob A. Troutman
- Active, not recruiting
Texas Tech University Health Sciences Center-Amarillo
Amarillo, Texas, 79106
- Recruiting
Kaiser Permanente-Anaheim
Anaheim, California, 92806
Site Public Contact, 800-398-3996, clinical.trials@kp.org
Robert M. Cooper
- Recruiting
Providence Alaska Medical Center
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Brenda J. Wittman
- Recruiting
C S Mott Children's Hospital
Ann Arbor, Michigan, 48109
Site Public Contact, 800-865-1125
Rama Jasty
- Recruiting
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
Site Public Contact, 800-865-1125, CancerAnswerLine@med.umich.edu
Rama Jasty
- Recruiting
PCR Oncology
Arroyo Grande, California, 93420
Site Public Contact, 702-384-0013, research@sncrf.org
Alan K. Ikeda
- Recruiting
Mission Hospital
Asheville, North Carolina, 28801
Site Public Contact, 828-213-7055, NCDV.ResearchRegulatory@HCAHealthcare.com
Douglas J. Scothorn
- Recruiting
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia, 30329
Site Public Contact, 404-785-0232, Olivia.Floyd@choa.org
William T. Cash
- Recruiting
Children's Hospital Colorado
Aurora, Colorado, 80045
Site Public Contact, 303-764-5056, josh.b.gordon@nsmtp.kp.org
Jonathan P. Roach
- Recruiting
Dell Children's Medical Center of Central Texas
Austin, Texas, 78723
Site Public Contact, 512-628-1902, TXAUS-DL-SFCHemonc.research@ascension.org
Shannon M. Cohn
- Recruiting
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201
Site Public Contact, 800-888-8823
Teresa A. York
- Recruiting
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Site Public Contact, 410-601-9083
Jason M. Fixler
- Recruiting
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
Site Public Contact, 410-955-8804, jhcccro@jhmi.edu
Brian H. Ladle
- Recruiting
Eastern Maine Medical Center
Bangor, Maine, 04401
Site Public Contact, 207-973-4274
Daniel L. Callaway
- Recruiting
Bronson Battle Creek
Battle Creek, Michigan, 49017
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Suspended
Overlake Medical Center
Bellevue, Washington, 98004
- Recruiting
Kaiser Permanente-Bellflower
Bellflower, California, 90706
Site Public Contact, 800-398-3996, clinical.trials@kp.org
Robert M. Cooper
- Recruiting
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600
Site Public Contact, 301-319-2100
Allen I. Stering
- Recruiting
Children's Hospital of Alabama
Birmingham, Alabama, 35233
Site Public Contact, 205-638-9285, oncologyresearch@peds.uab.edu
Jamie M. Aye
- Recruiting
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
Site Public Contact, 208-381-2774, eslinget@slhs.org
Martha M. Pacheco
- Recruiting
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Site Public Contact, 877-726-5130
Danielle B. Cameron
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Site Public Contact, 877-442-3324
Katherine A. Janeway
- Recruiting
Maimonides Medical Center
Brooklyn, New York, 11219
Site Public Contact, 718-765-2500
Mahmut Y. Celiker
- Active, not recruiting
University of Vermont and State Agricultural College
Burlington, Vermont, 05405
- Recruiting
Carson Tahoe Regional Medical Center
Carson City, Nevada, 89703
Site Public Contact, 702-384-0013, research@sncrf.org
Alan K. Ikeda
- Recruiting
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Site Public Contact, 877-668-0683, cancerclinicaltrials@med.unc.edu
Thomas B. Alexander
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Site Public Contact, 843-792-9321, hcc-clinical-trials@musc.edu
Aaron J. Cunningham
- Recruiting
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
Site Public Contact, 434-243-6303, uvacancertrials@hscmail.mcc.virginia.edu
Brian C. Belyea
- Recruiting
Lurie Children's Hospital-Chicago
Chicago, Illinois, 60611
Site Public Contact, 773-880-4562
Jennifer L. Reichek
- Recruiting
University of Illinois
Chicago, Illinois, 60612
Site Public Contact, 312-355-3046
Dipti S. Dighe
- Recruiting
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Site Public Contact, 773-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Ami V. Desai
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Site Public Contact, 513-636-2799, cancer@cchmc.org
Joseph G. Pressey
- Recruiting
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, 44106
Site Public Contact, 216-844-5437
Duncan S. Stearns
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Site Public Contact, 866-223-8100, TaussigResearch@ccf.org
Matteo M. Trucco
- Recruiting
University of Missouri Children's Hospital
Columbia, Missouri, 65212
Site Public Contact, 573-882-1960, snwq62@health.missouri.edu
Barbara A. Gruner
- Recruiting
Prisma Health Richland Hospital
Columbia, South Carolina, 29203
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Stuart L. Cramer
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Site Public Contact, 614-722-6039, Melinda.Triplet@nationwidechildrens.org
Mark A. Ranalli
- Recruiting
Driscoll Children's Hospital
Corpus Christi, Texas, 78411
Site Public Contact, 361-694-5311, Crystal.DeLosSantos@dchstx.org
Nkechi I. Mba
- Recruiting
Medical City Dallas Hospital
Dallas, Texas, 75230
Site Public Contact, 972-566-5588
Maurizio L. Ghisoli
- Recruiting
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu
Avanthi T. Shah
- Recruiting
Geisinger Medical Center
Danville, Pennsylvania, 17822
Site Public Contact, 570-271-5251, cancerresearch@geisinger.edu
Jagadeesh Ramdas
- Recruiting
Dayton Children's Hospital
Dayton, Ohio, 45404
Site Public Contact, 800-228-4055
Jordan M. Wright
- Recruiting
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver, Colorado, 80218
Site Public Contact, 303-832-2344, PSGResearchSharedMailbox@HCAHealthcare.com
Florence Choo
- Recruiting
Blank Children's Hospital
Des Moines, Iowa, 50309
Site Public Contact, 515-241-8912, samantha.mallory@unitypoint.org
Samantha L. Mallory
- Recruiting
Children's Hospital of Michigan
Detroit, Michigan, 48201
Site Public Contact, helpdesk@childrensoncologygroup.org
Danielle E. Bell
- Recruiting
Kaiser Permanente Downey Medical Center
Downey, California, 90242
Site Public Contact, 626-564-3455
Robert M. Cooper
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Site Public Contact, 888-275-3853
Jessica M. Sun
- Suspended
Michigan State University
East Lansing, Michigan, 48823
- Recruiting
El Paso Children's Hospital
El Paso, Texas, 79905
Site Public Contact, 915-298-5444, ranjan.bista@ttuhsc.edu
Benjamin Carcamo
- Recruiting
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Site Public Contact, 703-208-6650, Stephanie.VanBebber@inova.org
Robin Y. Dulman
- Recruiting
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org
Samuel J. Milanovich
- Recruiting
Kaiser Permanente-Fontana
Fontana, California, 92335
Site Public Contact, 800-398-3996, clinical.trials@kp.org
Robert M. Cooper
- Recruiting
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, 33908
Site Public Contact, 239-343-5333, molly.arnstrom@leehealth.org
Emad K. Salman
- Recruiting
Cook Children's Medical Center
Fort Worth, Texas, 76104
Site Public Contact, 682-885-2103, CookChildrensResearch@cookchildrens.org
Karen H. Albritton
- Active, not recruiting
UF Health Cancer Institute - Gainesville
Gainesville, Florida, 32610
- Recruiting
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
East Carolina University
Greenville, North Carolina, 27834
Site Public Contact, 252-744-1015, eubankss@ecu.edu
Andrea R. Whitfield
- Recruiting
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, 29605
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Aniket Saha
- Recruiting
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Site Public Contact, 551-996-2897
Katharine Offer
- Recruiting
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Site Public Contact, 860-545-9981
Michael S. Isakoff
- Recruiting
Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada, 89052
Site Public Contact, 702-384-0013, research@sncrf.org
Alan K. Ikeda
- Recruiting
Comprehensive Cancer Centers of Nevada-Horizon Ridge
Henderson, Nevada, 89052
Site Public Contact, 702-384-0013, research@sncrf.org
Alan K. Ikeda
- Suspended
Las Vegas Cancer Center-Henderson
Henderson, Nevada, 89052
- Recruiting
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson, Nevada, 89074
Site Public Contact, 702-384-0013, research@sncrf.org
Alan K. Ikeda
- Suspended
Las Vegas Urology - Green Valley
Henderson, Nevada, 89074
- Suspended
Las Vegas Urology - Pebble
Henderson, Nevada, 89074
- Recruiting
Oncology Las Vegas - Henderson
Henderson, Nevada, 89074
Site Public Contact, 702-384-0013, research@sncrf.org
Alan K. Ikeda
- Recruiting
Urology Specialists of Nevada - Green Valley
Henderson, Nevada, 89074
Site Public Contact, research@sncrf.org
Alan K. Ikeda
- Recruiting
Penn State Children's Hospital
Hershey, Pennsylvania, 17033
Site Public Contact, 717-531-6012
Lisa M. McGregor
- Recruiting
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
Site Public Contact, 808-983-6090
Wade T. Kyono
- Recruiting
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77030
Site Public Contact, 713-798-1354, burton@bcm.edu
Lisa L. Wang
- Recruiting
UT MD Anderson Cancer Center
Houston, Texas, 77030
Site Public Contact, 866-632-6789, askmdanderson@mdanderson.org
Najat C. Daw
- Recruiting
Riley Hospital for Children
Indianapolis, Indiana, 46202
Site Public Contact, 800-248-1199
Sandeep Batra
- Recruiting
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
Site Public Contact, 800-237-1225
Andrew P. Groves
- Recruiting
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Site Public Contact, 601-815-6700
Amanda Strobel
- Recruiting
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, 32207
Site Public Contact, 302-651-5572, Allison.bruce@nemours.org
Sridhi Patel
- Recruiting
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Beacon Kalamazoo Cancer Center
Kalamazoo, Michigan, 49009
Site Public Contact, 574-647-7370
Kathleen Y. Butler
- Recruiting
Beacon Kalamazoo
Kalamazoo, Michigan, 49048
Site Public Contact, 574-647-7370
Kathleen Y. Butler
- Recruiting
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
Site Public Contact, 816-302-6808, COGResearchGroup@cmh.edu
Keith J. August
- Recruiting
Kingman Regional Medical Center
Kingman, Arizona, 86401
Site Public Contact, 702-384-0013, research@sncrf.org
Alan K. Ikeda
- Recruiting
East Tennessee Childrens Hospital
Knoxville, Tennessee, 37916
Site Public Contact, 865-541-8266
Susan E. Spiller
- Suspended
Las Vegas Urology - Pecos
Las Vegas, Nevada, 89074
- Recruiting
OptumCare Cancer Care at Charleston
Las Vegas, Nevada, 89102
Site Public Contact, 702-384-0013, research@sncrf.org
Alan K. Ikeda
- Recruiting
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102
Site Public Contact, 702-384-0013, research@sncrf.org
Alan K. Ikeda
- Recruiting
Hope Cancer Care of Nevada
Las Vegas, Nevada, 89103
Site Public Contact, 702-384-0013, research@sncrf.org
Alan K. Ikeda
- Recruiting
Radiation Oncology Centers of Nevada Central
Las Vegas, Nevada, 89106
Site Public Contact, 702-384-0013, research@sncrf.org
Alan K. Ikeda
- Recruiting
Urology Specialists of Nevada - Central
Las Vegas, Nevada, 89106
Site Public Contact, research@sncrf.org
Alan K. Ikeda
- Recruiting
Sunrise Hospital and Medical Center
Las Vegas, Nevada, 89109
Site Public Contact, 702-384-0013, research@sncrf.org
Alan K. Ikeda
- Suspended
Las Vegas Urology - Sunset
Las Vegas, Nevada, 89113
- Recruiting
Urology Specialists of Nevada - Southwest
Las Vegas, Nevada, 89113
Site Public Contact, research@sncrf.org
Alan K. Ikeda
- Recruiting
Radiation Oncology Centers of Nevada Southeast
Las Vegas, Nevada, 89119
Site Public Contact, 702-384-0013, research@sncrf.org
Alan K. Ikeda
- Suspended
Ann M Wierman MD LTD
Las Vegas, Nevada, 89128
- Recruiting
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada, 89128
Site Public Contact, 702-384-0013, research@sncrf.org
Alan K. Ikeda
- Suspended
Las Vegas Urology - Cathedral Rock
Las Vegas, Nevada, 89128
- Suspended
Las Vegas Urology - Smoke Ranch
Las Vegas, Nevada, 89128
- Recruiting
Oncology Las Vegas - Tenaya
Las Vegas, Nevada, 89128
Site Public Contact, 702-384-0013, research@sncrf.org
Alan K. Ikeda
- Recruiting
OptumCare Cancer Care at MountainView
Las Vegas, Nevada, 89128
Site Public Contact, 702-384-0013, research@sncrf.org
Alan K. Ikeda
- Recruiting
Urology Specialists of Nevada - Northwest
Las Vegas, Nevada, 89128
Site Public Contact, research@sncrf.org
Alan K. Ikeda
- Recruiting
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, 89135
Site Public Contact, 702-384-0013, research@sncrf.org
Alan K. Ikeda
- Recruiting
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas, Nevada, 89144
Site Public Contact, 702-384-0013, research@sncrf.org
Alan K. Ikeda
- Recruiting
Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas, Nevada, 89144
Site Public Contact, 702-384-0013, research@sncrf.org
Alan K. Ikeda
- Recruiting
Summerlin Hospital Medical Center
Las Vegas, Nevada, 89144
Site Public Contact, 702-384-0013, research@sncrf.org
Alan K. Ikeda
- Suspended
Las Vegas Cancer Center-Medical Center
Las Vegas, Nevada, 89148-2405
- Recruiting
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89148
Site Public Contact, 702-384-0013, research@sncrf.org
Alan K. Ikeda
- Recruiting
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada, 89169
Site Public Contact, 702-384-0013, research@sncrf.org
Alan K. Ikeda
- Recruiting
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, 89183
Site Public Contact, 702-384-0013, research@sncrf.org
Alan K. Ikeda
- Recruiting
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756
Site Public Contact, 800-639-6918, cancer.research.nurse@dartmouth.edu
Angela Ricci
- Recruiting
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536
Site Public Contact, 859-257-3379
James T. Badgett
- Recruiting
Arkansas Children's Hospital
Little Rock, Arkansas, 72202-3591
Site Public Contact, 501-364-7373
Michael W. Bishop
- Recruiting
Loma Linda University Medical Center
Loma Linda, California, 92354
Site Public Contact, 909-558-4050
Albert Kheradpour
- Recruiting
Miller Children's and Women's Hospital Long Beach
Long Beach, California, 90806
Site Public Contact, 562-933-5600
Jacqueline N. Casillas
- Recruiting
Children's Hospital Los Angeles
Los Angeles, California, 90027
Site Public Contact, 323-361-4110
Fariba Navid
- Recruiting
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
Site Public Contact, 800-398-3996, clinical.trials@kp.org
Robert M. Cooper
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Site Public Contact, 310-423-2133, Cancer.trial.info@cshs.org
Leo Mascarenhas
- Recruiting
Norton Children's Hospital
Louisville, Kentucky, 40202
Site Public Contact, 502-629-5500, CancerResource@nortonhealthcare.org
Michael J. Ferguson
- Recruiting
Valley Children's Hospital
Madera, California, 93636
Site Public Contact, 559-353-3000, Research@valleychildrens.org
Ruetima Titapiwatanakun
- Recruiting
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, 53718
Site Public Contact, 800-622-8922, clinicaltrials@cancer.wisc.edu
Margo L. Hoover-Regan
- Recruiting
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792
Site Public Contact, 800-622-8922, clinicaltrials@cancer.wisc.edu
Margo L. Hoover-Regan
- Recruiting
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Michelle A. Manalang
- Recruiting
Loyola University Medical Center
Maywood, Illinois, 60153
Site Public Contact, 708-226-4357
Eugene Suh
- Recruiting
Saint Jude Children's Research Hospital
Memphis, Tennessee, 38105
Site Public Contact, 888-226-4343, referralinfo@stjude.org
Lindsay J. Talbot
- Recruiting
Banner Children's at Desert
Mesa, Arizona, 85202
Site Public Contact, 480-412-3100
Joseph C. Torkildson
- Recruiting
Nicklaus Children's Hospital
Miami, Florida, 33155
Site Public Contact, 888-624-2778
Maggie E. Fader
- Recruiting
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
Site Public Contact, 414-955-4727, MACCCTO@mcw.edu
Nathan J. Schloemer
- Recruiting
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, 55404
Site Public Contact, 612-813-5913, pauline.mitby@childrensmn.org
Michael K. Richards
- Recruiting
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455
Site Public Contact, 612-624-2620
Robin L. Williams
- Recruiting
West Virginia University Healthcare
Morgantown, West Virginia, 26506
Site Public Contact, 304-293-7374, cancertrialsinfo@hsc.wvu.edu
Ashley E. Meyer
- Recruiting
Morristown Medical Center
Morristown, New Jersey, 07960
Site Public Contact, 973-971-5900
Kathryn L. Laurie
- Recruiting
Trinity Health Muskegon Hospital
Muskegon, Michigan, 49444
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
The Children's Hospital at TriStar Centennial
Nashville, Tennessee, 37203
Site Public Contact, 615-342-1919
Clinton M. Carroll
- Recruiting
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
Site Public Contact, 800-811-8480
Scott C. Borinstein
- Recruiting
Saint Peter's University Hospital
New Brunswick, New Jersey, 08901
Site Public Contact, 732-745-8600 ext. 6163, kcovert@saintpetersuh.com
Nibal A. Zaghloul
- Recruiting
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903
Site Public Contact, 732-235-8675
Scott Moerdler
- Recruiting
Smilow Cancer Center/Yale-New Haven Hospital
New Haven, Connecticut, 06510
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Farzana Pashankar
- Recruiting
Yale University
New Haven, Connecticut, 06520
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Farzana Pashankar
- Recruiting
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, 11040
Site Public Contact, 718-470-3460
Carolyn F. Levy
- Recruiting
Children's Hospital New Orleans
New Orleans, Louisiana, 70118
Site Public Contact, 504-894-5377
Maria C. Velez-Yanguas
- Recruiting
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121
Site Public Contact, 504-842-8084, Elisemarie.curry@ochsner.org
Craig Lotterman
- Recruiting
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016
Site Public Contact, CancerTrials@nyulangone.org
Elizabeth A. Raetz
- Recruiting
Mount Sinai Hospital
New York, New York, 10029
Site Public Contact, 212-824-7309, CCTO@mssm.edu
Pamela R. Merola
- Recruiting
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
Site Public Contact, 212-342-5162, cancerclinicaltrials@cumc.columbia.edu
Nobuko Hijiya
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Site Public Contact, 212-639-7592
Damon R. Reed
- Recruiting
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan, 49120
Site Public Contact, 616-391-1230
Kathleen Y. Butler
- Recruiting
Children's Hospital of The King's Daughters
Norfolk, Virginia, 23507
Site Public Contact, 757-668-7243, CCBDCresearch@chkd.org
Melissa S. Mark
- Suspended
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan, 49444
- Recruiting
Kaiser Permanente-Oakland
Oakland, California, 94611
Site Public Contact, 877-642-4691, Kpoct@kp.org
Aarati V. Rao
- Recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Site Public Contact, 405-271-8777, ou-clinical-trials@ouhsc.edu
Rene Y. McNall-Knapp
- Recruiting
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, 68114
Site Public Contact, 402-955-3949
Jill C. Beck
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Site Public Contact, 402-559-6941, unmcrsa@unmc.edu
Jill C. Beck
- Recruiting
Children's Hospital of Orange County
Orange, California, 92868
Site Public Contact, 714-509-8646, oncresearch@choc.org
Elyssa M. Rubin
- Recruiting
Arnold Palmer Hospital for Children
Orlando, Florida, 32806
Site Public Contact, 321-841-5357, Jennifer.spinelli@orlandohealth.com
Zhongbo Hu
- Recruiting
Nemours Children's Hospital
Orlando, Florida, 32827
Site Public Contact, 302-651-5572, Allison.bruce@nemours.org
Sridhi Patel
- Recruiting
Hope Cancer Care of Nevada-Pahrump
Pahrump, Nevada, 89048
Site Public Contact, 702-384-0013, research@sncrf.org
Alan K. Ikeda
- Recruiting
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, 94304
Site Public Contact, 800-694-0012, ccto-office@stanford.edu
Jay Michael S. Balagtas
- Recruiting
Saint Joseph's Regional Medical Center
Paterson, New Jersey, 07503
Site Public Contact, 973-754-2207, HallL@sjhmc.org
Alissa Kahn
- Recruiting
OSF Children's Hospital of Illinois
Peoria, Illinois, 61637
Site Public Contact, 309-624-4945, ChildrensHospitalofIllinois@osfhealthcare.org
Prerna Kumar
- Recruiting
Saint Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134
Site Public Contact, 215-427-8991
Gregory E. Halligan
- Recruiting
Phoenix Childrens Hospital
Phoenix, Arizona, 85016
Site Public Contact, 602-546-0920
Alok K. Kothari
- Recruiting
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
Site Public Contact, 412-692-8570, jean.tersak@chp.edu
Jean M. Tersak
- Recruiting
Legacy Emanuel Children's Hospital
Portland, Oregon, 97227
Site Public Contact, 503-413-2560
Jason M. Glover
- Recruiting
Oregon Health and Science University
Portland, Oregon, 97239
Site Public Contact, 503-494-1080, trials@ohsu.edu
Katrina Winsnes
- Recruiting
Rhode Island Hospital
Providence, Rhode Island, 02903
Site Public Contact, 401-444-1488
Bradley DeNardo
- Recruiting
Corewell Health Reed City Hospital
Reed City, Michigan, 49677
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Renown Regional Medical Center
Reno, Nevada, 89502
Site Public Contact, 775-982-5050, Renown-CRD@renown.org
Alan K. Ikeda
- Recruiting
Saint Mary's Regional Medical Center
Reno, Nevada, 89503
Site Public Contact, 702-384-0013, research@sncrf.org
Alan K. Ikeda
- Suspended
Radiation Oncology Associates
Reno, Nevada, 89509
- Suspended
Northern Nevada Radiation Oncology
Reno, Nevada, 89521
- Recruiting
Valley Medical Center
Renton, Washington, 98055
Site Public Contact, 425-228-3440, research@valleymed.org
Alan K. Ikeda
- Recruiting
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, 23235
Site Public Contact, ctoclinops@vcu.edu
Laura Boomer
- Recruiting
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298
Site Public Contact, 804-628-6430, CTOclinops@vcu.edu
Laura Boomer
- Recruiting
Carilion Children's
Roanoke, Virginia, 24014
Site Public Contact, 540-266-6238, wpmccarty@carilionclinic.org
Erwood G. Edwards
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Site Public Contact, 855-776-0015
Stephanie F. Polites
- Recruiting
Corewell Health Children's
Royal Oak, Michigan, 48073
Site Public Contact, 248-551-7695
Marie V. Nelson
- Recruiting
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
Site Public Contact, 916-734-3089
Marcio H. Malogolowkin
- Recruiting
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan, 49085
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Primary Children's Hospital
Salt Lake City, Utah, 84113
Site Public Contact, 801-585-5270
Matthew Dietz
- Recruiting
Children's Hospital of San Antonio
San Antonio, Texas, 78207
Site Public Contact, 210-704-2894, bridget.medina@christushealth.org
Julie Voeller
- Recruiting
Methodist Children's Hospital of South Texas
San Antonio, Texas, 78229
Site Public Contact, 210-575-6240, Vinod.GidvaniDiaz@hcahealthcare.com
Jose M. Esquilin
- Recruiting
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Site Public Contact, 210-450-3800, phoresearchoffice@uthscsa.edu
Aaron J. Sugalski
- Recruiting
Kaiser Permanente-San Diego Zion
San Diego, California, 92120
Site Public Contact, 800-398-3996, clinical.trials@kp.org
Robert M. Cooper
- Recruiting
Rady Children's Hospital - San Diego
San Diego, California, 92123
Site Public Contact, 858-966-5934
William D. Roberts
- Recruiting
UCSF Medical Center-Mission Bay
San Francisco, California, 94158
Site Public Contact, 877-827-3222, cancertrials@ucsf.edu
Arun A. Rangaswami
- Recruiting
Maine Children's Cancer Program
Scarborough, Maine, 04074
Site Public Contact, 207-396-8670, clinicalresearch@mainehealth.org
Aaron R. Weiss
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Site Public Contact, 866-987-2000
Sarah E. Leary
- Recruiting
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134
Site Public Contact, 605-312-3320, OncologyClinicalTrialsSF@SanfordHealth.org
Jordan Fritch-Hanson
- Recruiting
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, 99204
Site Public Contact, 800-228-6618, HopeBeginsHere@providence.org
Judy L. Felgenhauer
- Recruiting
Cardinal Glennon Children's Medical Center
St Louis, Missouri, 63104
Site Public Contact, 314-268-4000
William S. Ferguson
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Amy Armstrong
- Recruiting
Mercy Hospital Saint Louis
St Louis, Missouri, 63141
Site Public Contact, 314-251-7066
Robin D. Hanson
- Recruiting
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701
Site Public Contact, 727-767-4784, Ashley.Repp@jhmi.edu
Jennifer B. Dean
- Recruiting
Stony Brook University Medical Center
Stony Brook, New York, 11794
Site Public Contact, 800-862-2215
Laura E. Hogan
- Recruiting
State University of New York Upstate Medical University
Syracuse, New York, 13210
Site Public Contact, 315-464-5476
Melanie A. Comito
- Recruiting
Mary Bridge Children's Hospital and Health Center
Tacoma, Washington, 98405
Site Public Contact, 253-403-1461, research@multicare.org
Robert G. Irwin
- Recruiting
Madigan Army Medical Center
Tacoma, Washington, 98431
Site Public Contact, 253-968-6144, melissa.a.forouhar.mil@health.mil
Melissa A. Forouhar
- Recruiting
Tampa General Hospital
Tampa, Florida, 33606
Site Public Contact, 813-844-7829, syapchanyk@tgh.org
Andrew J. Galligan
- Recruiting
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, 33607
Site Public Contact, 813-357-0849, jennifer.manns@baycare.org
Don E. Eslin
- Recruiting
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461
Site Public Contact, 718-379-6866, eskwak@montefiore.org
Alice Lee
- Recruiting
Montefiore Medical Center-Weiler Hospital
The Bronx, New York, 10461
Site Public Contact, 718-379-6866, eskwak@montefiore.org
Alice Lee
- Recruiting
Children's Hospital at Montefiore
The Bronx, New York, 10467
Site Public Contact, 718-379-6866, aaraiza@montefiore.org
Alice Lee
- Recruiting
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467
Site Public Contact, 718-379-6866, eskwak@montefiore.org
Alice Lee
- Recruiting
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo, Ohio, 43606
Site Public Contact, 419-824-1842, PCIOncResearch@promedica.org
Jamie L. Dargart
- Recruiting
Munson Medical Center
Traverse City, Michigan, 49684
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Banner University Medical Center - Tucson
Tucson, Arizona, 85719
Site Public Contact, UACC-IIT@uacc.arizona.edu
Michelina de la Maza
- Recruiting
New York Medical College
Valhalla, New York, 10595
Site Public Contact, 914-594-3794
Andrew J. Bellantoni
- Suspended
Westchester Medical Center
Valhalla, New York, 10595
- Recruiting
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Site Public Contact, 202-476-2800, OncCRC_OnCall@childrensnational.org
Jeffrey S. Dome
- Recruiting
Alfred I duPont Hospital for Children
Wilmington, Delaware, 19803
Site Public Contact, 302-651-5572, Allison.bruce@nemours.org
Sridhi Patel
- Recruiting
Northwestern Medicine Central DuPage Hospital
Winfield, Illinois, 60190
Site Public Contact, 630-315-1918, Claudine.Gamster@CadenceHealth.org
Jennifer L. Reichek
- Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Site Public Contact, 336-713-6771
Sarah Supples
- Recruiting
University of Michigan Health - West
Wyoming, Michigan, 49519
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington, 98902
Site Public Contact, 509-574-3535, Memorial-ClinicalTrials@yvmh.org
Alan K. Ikeda
Canada6 sites, 6 recruiting
- Recruiting
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
Site Public Contact, 403-220-6898, research4kids@ucalgary.ca
Victor A. Lewis
- Recruiting
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
Site Public Contact, 780-407-8798, pedsoncologyresearch@ahs.ca
Sarah J. McKillop
- Recruiting
IWK Health Centre
Halifax, Nova Scotia, B3K 6R8
Site Public Contact, 902-470-8520, Research@iwk.nshealth.ca
Chelsea Ash
- Recruiting
The Montreal Children's Hospital of the MUHC
Montreal, Quebec, H3H 1P3
Site Public Contact, 514-412-4445, info@thechildren.com
Stephanie Mourad
- Recruiting
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, H3T 1C5
Site Public Contact, 514-345-4931, yvan.samson@umontreal.ca
Monia Marzouki
- Recruiting
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Sherbrooke, Quebec, J1H 5N4
Site Public Contact, 819-820-6480, crcinformation.chus@ssss.gouv.qc.ca
Josee Brossard
Australia3 sites
- Suspended
Royal Children's Hospital
Parkville, Victoria, 3052
- Suspended
Perth Children's Hospital
Perth, Western Australia, 6009
- Suspended
The Children's Hospital at Westmead
Westmead, New South Wales, 2145
New Zealand2 sites, 2 recruiting
- Recruiting
Christchurch Hospital
Christchurch, 8011
Site Public Contact, 03 364 0640
Tristan Pettit
- Recruiting
Starship Children's Hospital
Grafton, Auckland, 1145
Site Public Contact, 0800 728 436
Mandy PohLui de Silva
Puerto Rico1 site
- Active, not recruiting
HIMA San Pablo Oncologic Hospital
Caguas, 00726
Saudi Arabia1 site
- Suspended
King Faisal Specialist Hospital and Research Centre
Riyadh, 11211
About this study
Official title: A Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine if open surgical resection is superior to thoracoscopic resection for thoracic event-free survival (tEFS) in patients with resectable oligometastatic pulmonary osteosarcoma.
SECONDARY OBJECTIVES:
- To determine if open surgical resection is superior to thoracoscopy for event free survival (EFS) in patients with resectable oligometastatic pulmonary osteosarcoma.
II. To determine if open surgical resection is superior to thoracoscopy for overall survival (OS) in patients with resectable oligometastatic pulmonary osteosarcoma.
EXPLORATORY OBJECTIVES:
- To compare 30-day rates of perioperative surgical complications for both open surgical resection and thoracoscopy.
II. To compare patterns of recurrence (ipsilateral and/or contralateral) in patients who undergo open or thoracoscopic resection for unilateral or bilateral pulmonary metastases.
III. To describe the use of localization techniques and its relationship with both surgical approach and pathologic findings.
IV. To assess the prognostic significance of a decision to change the post-operative treatment plan.
- To describe the relationship between the preoperative chest computed tomography (CT) imaging, intraoperative surgical findings, and pathologic results, comparing radiological features to the presence of viable tumor.
VI. To generate well-characterized, clinically-annotated, distributable models of metastatic osteosarcoma.
VII. To collect and bank pulmonary metastatic lesions (including frozen tissues and paired metastatic lesions coming from the same patient) to facilitate study of metastatic disease and serial blood samples for future tumor profiling, germline and circulating tumor deoxyribonucleic acid (DNA) studies.
OUTLINE: Patients are randomized into 1 of 2 arms.
ARM A: Patients undergo open thoracic surgery (thoracotomy).
ARM B: Patients undergo thoracoscopy (video-assisted thoracoscopic surgery or VATS).
All patients undergo computed tomography (CT) throughout the trial. Patients may also undergo collection of tissue on study and blood throughout the trial.
After completion of study treatment, patients are followed up at 7-14 days, 4-6 weeks, and 3 months post-surgery and then every 3 months for up to 2 years.
- Being tested
- Biospecimen Collection, Computed Tomography, Questionnaire Administration, Thoracoscopy, Thoracotomy
- Medical subject headings
- Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo collection of tissue and blood
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT
Questionnaire AdministrationOther
Ancillary studies
ThoracoscopyProcedure or surgery
Also called Pleuroscopy
Undergo video-assisted thoracoscopic surgery or VATS
ThoracotomyProcedure or surgery
Also called incision of Chest Wall, Incision of Thorax
Undergo open thoracic surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm A (thoracotomy) | Experimental | Patients undergo open thoracic surgery (thoracotomy). Patients undergo CT throughout the trial. Patients may also undergo collection of tissue on study and blood throughout the trial. Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Other: Questionnaire Administration; Procedure: Thoracotomy |
| Arm B (thoracoscopy) | Experimental | Patients undergo thoracoscopy (video-assisted thoracoscopic surgery or VATS). Patients undergo CT throughout the trial. Patients may also undergo collection of tissue on study and blood throughout the trial. Receives: Procedure: Biospecimen Collection; Other: Questionnaire Administration; Procedure: Thoracoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thoracic event-free survival (tEFS)
Estimated four year thoracic event free survival (tEFS) where tEFS is calculated as the time from study enrollment to thoracic cavity event. Any recurrence within the pulmonary parenchyma, involving the pleural surface or the drain/surgical site wound will be considered an event. A death that results from the procedure, as confirmed by the treating physician, will be considered an event. Patients with recurrences arising outside the thoracic region, the diagnosis of a malignancy that is not osteosarcoma (SMN) or death considered unrelated to the study surgical procedure, as confirmed by the treating physician will be considered competing events provided these occur prior to a thoracic cavity event as defined above. Patients without an event of any kind at last contact are considered censored.
Measured: Four years after enrollment
Secondary outcomes (2)
Event free survival (EFS)
Estimated four year EFS where EFS is calculated as the time from study enrollment to disease progression, disease relapse, occurrence of a second malignant neoplasm, death from any cause or last follow-up whichever occurs first. Patients without an event at last contact are considered censored.
Measured: Four years after enrollment
Overall survival (OS)
Time from study enrollment to death or last patient contact. Patients alive at last contact are considered censored.
Measured: Four years after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start1 Apr 2022
- Primary completion31 Mar 2031 (estimated)
- Study completion31 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Malignant Neoplasm in the LungStudies of the same condition, open and under way.
- More trials run by Children's Oncology GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- John J Doski, Principal investigator, Children's Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05235165
- Sponsor's protocol ID
- AOST2031
- Other IDs
- NCI-2021-14237, AOST2031, AOST2031, U10CA180886
- Status last verified
- Feb 2026
- First submitted
- 19 Jan 2022
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma
- ClinicalTrials.gov ID
- NCT05235165
- Acronym / sponsor ID
- AOST2031
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Mar 2031 (estimated)
- Study completion
- 31 Mar 2031 (estimated)
- First posted
- 11 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- To determine if open surgical resection is superior to thoracoscopic resection for thoracic event-free survival (tEFS) in patients with resectable oligometastatic pulmonary osteosarcoma.
SECONDARY OBJECTIVES:
- To determine if open surgical resection is superior to thoracoscopy for event free survival (EFS) in patients with resectable oligometastatic pulmonary osteosarcoma.
II. To determine if open surgical resection is superior to thoracoscopy for overall survival (OS) in patients with resectable oligometastatic pulmonary osteosarcoma.
EXPLORATORY OBJECTIVES:
- To compare 30-day rates of perioperative surgical complications for both open surgical resection and thoracoscopy.
II. To compare patterns of recurrence (ipsilateral and/or contralateral) in patients who undergo open or thoracoscopic resection for unilateral or bilateral pulmonary metastases.
III. To describe the use of localization techniques and its relationship with both surgical approach and pathologic findings.
IV. To assess the prognostic significance of a decision to change the post-operative treatment plan.
- To describe the relationship between the preoperative chest computed tomography (CT) imaging, intraoperative surgical findings, and pathologic results, comparing radiological features to the presence of viable tumor.
VI. To generate well-characterized, clinically-annotated, distributable models of metastatic osteosarcoma.
VII. To collect and bank pulmonary metastatic lesions (including frozen tissues and paired metastatic lesions coming from the same patient) to facilitate study of metastatic disease and serial blood samples for future tumor profiling, germline and circulating tumor deoxyribonucleic acid (DNA) studies.
OUTLINE: Patients are randomized into 1 of 2 arms.
ARM A: Patients undergo open thoracic surgery (thoracotomy).
ARM B: Patients undergo thoracoscopy (video-assisted thoracoscopic surgery or VATS).
All patients undergo computed tomography (CT) throughout the trial. Patients may also undergo collection of tissue on study and blood throughout the trial.
After completion of study treatment, patients are followed up at 7-14 days, 4-6 weeks, and 3 months post-surgery and then every 3 months for up to 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (thoracotomy) | Experimental | Procedure: Biospecimen Collection, Procedure: Computed Tomography, Other: Questionnaire Administration, Procedure: ThoracotomyPatients undergo open thoracic surgery (thoracotomy). Patients undergo CT throughout the trial. Patients may also undergo collection of tissue on study and blood throughout the trial. |
| Arm B (thoracoscopy) | Experimental | Procedure: Biospecimen Collection, Other: Questionnaire Administration, Procedure: ThoracoscopyPatients undergo thoracoscopy (video-assisted thoracoscopic surgery or VATS). Patients undergo CT throughout the trial. Patients may also undergo collection of tissue on study and blood throughout the trial. |
Who may qualify
- Ages
- Up to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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.
- 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.
Key exclusion criteria (8 listed)
- Patients with unresectable primary tumor.
- 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 chest wall or mediastinal based metastatic lesions, or with significant pleural effusion.
- 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 with evidence of extrapulmonary metastatic disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo collection of tissue and blood | Procedure or surgery | Arm A (thoracotomy), Arm B (thoracoscopy) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo CT | Procedure or surgery | Arm A (thoracotomy) |
| Questionnaire AdministrationAncillary studies | Other | Arm A (thoracotomy), Arm B (thoracoscopy) |
| ThoracoscopyAlso: PleuroscopyUndergo video-assisted thoracoscopic surgery or VATS | Procedure or surgery | Arm B (thoracoscopy) |
| ThoracotomyAlso: incision of Chest Wall, Incision of ThoraxUndergo open thoracic surgery | Procedure or surgery | Arm A (thoracotomy) |
Primary outcome
Thoracic event-free survival (tEFS)
Time frame: Four years after enrollment
Estimated four year thoracic event free survival (tEFS) where tEFS is calculated as the time from study enrollment to thoracic cavity event. Any recurrence within the pulmonary parenchyma, involving the pleural surface or the drain/surgical site wound will be considered an event. A death that results from the procedure, as confirmed by the treating physician, will be considered an event. Patients with recurrences arising outside the thoracic region, the diagnosis of a malignancy that is not osteosarcoma (SMN) or death considered unrelated to the study surgical procedure, as confirmed by the treating physician will be considered competing events provided these occur prior to a thoracic cavity event as defined above. Patients without an event of any kind at last contact are considered censored.
2 secondary outcomes
Event free survival (EFS)
Time frame: Four years after enrollment
Overall survival (OS)
Time frame: Four years after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Providence Alaska Medical Center
Anchorage, United States
John J Doski principal investigator
Children's Oncology Group
233 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Biospecimen Collection, Computed Tomography and Questionnaire Administration in people with Metastatic Malignant Neoplasm in the Lung and Metastatic Osteosarcoma, run by Children's Oncology Group at 233 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 233 sites in United States, Canada, Australia, New Zealand, Puerto Rico and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thoracic event-free survival (tEFS) (time frame: Four years after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.