RECRUITING

Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma

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Conditions

Metastatic Malignant Neoplasm in the LungMetastatic OsteosarcomaOsteosarcoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-04-01
Study Completion:2031-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05235165

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients must be \< 50 years at the time of enrollment.
  2. * 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.
  3. * Note: Patient must have eligibility confirmed by rapid central imaging review.
  4. * Lung nodules must be considered resectable by either open thoracotomy or thoracoscopic surgery. Determination of resectability is made by the institutional surgeon.
  5. * Patients must have a histological diagnosis of osteosarcoma.
  6. * 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.
  7. * 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.
  8. * 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.
  9. * 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.
  1. * Patients with unresectable primary tumor.
  2. * 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).
  3. * Patients with chest wall or mediastinal based metastatic lesions, or with significant pleural effusion.
  4. * 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.
  5. * Patients with evidence of extrapulmonary metastatic disease.
  6. * Patients who received therapeutic pulmonary surgery for lung metastasis prior to enrollment.
  7. * All patients and/or their parents or legal guardians must sign a written informed consent.
  8. * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.

Contacts and Locations

Principal Investigator

John J Doski
PRINCIPAL_INVESTIGATOR
Children's Oncology Group

Study Locations (Sites)

Children's Hospital of Alabama
Birmingham, Alabama, 35233
United States
Providence Alaska Medical Center
Anchorage, Alaska, 99508
United States
Kingman Regional Medical Center
Kingman, Arizona, 86401
United States
Banner Children's at Desert
Mesa, Arizona, 85202
United States
Phoenix Childrens Hospital
Phoenix, Arizona, 85016
United States
Banner University Medical Center - Tucson
Tucson, Arizona, 85719
United States
Arkansas Children's Hospital
Little Rock, Arkansas, 72202-3591
United States
Kaiser Permanente-Anaheim
Anaheim, California, 92806
United States
PCR Oncology
Arroyo Grande, California, 93420
United States
Kaiser Permanente-Bellflower
Bellflower, California, 90706
United States
Kaiser Permanente Downey Medical Center
Downey, California, 90242
United States
Kaiser Permanente-Fontana
Fontana, California, 92335
United States
Loma Linda University Medical Center
Loma Linda, California, 92354
United States
Miller Children's and Women's Hospital Long Beach
Long Beach, California, 90806
United States
Children's Hospital Los Angeles
Los Angeles, California, 90027
United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
United States
Cedars Sinai Medical Center
Los Angeles, California, 90048
United States
Valley Children's Hospital
Madera, California, 93636
United States
Kaiser Permanente-Oakland
Oakland, California, 94611
United States
Children's Hospital of Orange County
Orange, California, 92868
United States
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, 94304
United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
United States
Kaiser Permanente-San Diego Zion
San Diego, California, 92120
United States
Rady Children's Hospital - San Diego
San Diego, California, 92123
United States
UCSF Medical Center-Mission Bay
San Francisco, California, 94158
United States
Children's Hospital Colorado
Aurora, Colorado, 80045
United States
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver, Colorado, 80218
United States
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
United States
Smilow Cancer Center/Yale-New Haven Hospital
New Haven, Connecticut, 06510
United States
Yale University
New Haven, Connecticut, 06520
United States
Alfred I duPont Hospital for Children
Wilmington, Delaware, 19803
United States
Children's National Medical Center
Washington, District of Columbia, 20010
United States
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, 33908
United States
University of Florida Health Science Center - Gainesville
Gainesville, Florida, 32610
United States
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, 32207
United States
Nicklaus Children's Hospital
Miami, Florida, 33155
United States
Nemours Children's Hospital
Orlando, Florida, 32827
United States
Johns Hopkins All Children's Hospital
Saint Petersburg, Florida, 33701
United States
Tampa General Hospital
Tampa, Florida, 33606
United States
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, 33607
United States
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia, 30329
United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
United States
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
United States
Lurie Children's Hospital-Chicago
Chicago, Illinois, 60611
United States
University of Illinois
Chicago, Illinois, 60612
United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
United States
Loyola University Medical Center
Maywood, Illinois, 60153
United States
Saint Jude Midwest Affiliate
Peoria, Illinois, 61637
United States
Northwestern Medicine Central DuPage Hospital
Winfield, Illinois, 60190
United States
Riley Hospital for Children
Indianapolis, Indiana, 46202
United States
Blank Children's Hospital
Des Moines, Iowa, 50309
United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536
United States
Norton Children's Hospital
Louisville, Kentucky, 40202
United States
Children's Hospital New Orleans
New Orleans, Louisiana, 70118
United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121
United States
Eastern Maine Medical Center
Bangor, Maine, 04401
United States
Maine Children's Cancer Program
Scarborough, Maine, 04074
United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201
United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
United States
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600
United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
C S Mott Children's Hospital
Ann Arbor, Michigan, 48109
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
United States
Bronson Battle Creek
Battle Creek, Michigan, 49017
United States
Children's Hospital of Michigan
Detroit, Michigan, 48201
United States
Michigan State University Clinical Center
East Lansing, Michigan, 48824
United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503
United States
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503
United States
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503
United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
United States
Ascension Borgess Cancer Center
Kalamazoo, Michigan, 49009
United States
Ascension Borgess Hospital
Kalamazoo, Michigan, 49048
United States
Trinity Health Muskegon Hospital
Muskegon, Michigan, 49444
United States
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan, 49120
United States
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan, 49444
United States
Corewell Health Reed City Hospital
Reed City, Michigan, 49677
United States
Corewell Health Children's
Royal Oak, Michigan, 48073
United States
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085
United States
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan, 49085
United States
Munson Medical Center
Traverse City, Michigan, 49684
United States
University of Michigan Health - West
Wyoming, Michigan, 49519
United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, 55404
United States
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455
United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216
United States
University of Missouri Children's Hospital
Columbia, Missouri, 65212
United States
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
United States
Cardinal Glennon Children's Medical Center
Saint Louis, Missouri, 63104
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
Mercy Hospital Saint Louis
Saint Louis, Missouri, 63141
United States
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, 68114
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198
United States
Carson Tahoe Regional Medical Center
Carson City, Nevada, 89703
United States
Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada, 89052
United States
Comprehensive Cancer Centers of Nevada-Horizon Ridge
Henderson, Nevada, 89052
United States
Las Vegas Cancer Center-Henderson
Henderson, Nevada, 89052
United States
OptumCare Cancer Care at Seven Hills
Henderson, Nevada, 89052
United States
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson, Nevada, 89074
United States
GenesisCare USA - Henderson
Henderson, Nevada, 89074
United States
Las Vegas Urology - Green Valley
Henderson, Nevada, 89074
United States
Las Vegas Urology - Pebble
Henderson, Nevada, 89074
United States
Urology Specialists of Nevada - Green Valley
Henderson, Nevada, 89074
United States
Las Vegas Urology - Pecos
Las Vegas, Nevada, 89074
United States
OptumCare Cancer Care at Charleston
Las Vegas, Nevada, 89102
United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102
United States
Hope Cancer Care of Nevada
Las Vegas, Nevada, 89103
United States
Radiation Oncology Centers of Nevada Central
Las Vegas, Nevada, 89106
United States
Urology Specialists of Nevada - Central
Las Vegas, Nevada, 89106
United States
GenesisCare USA - Las Vegas
Las Vegas, Nevada, 89109
United States
Sunrise Hospital and Medical Center
Las Vegas, Nevada, 89109
United States
Las Vegas Urology - Sunset
Las Vegas, Nevada, 89113
United States
Urology Specialists of Nevada - Southwest
Las Vegas, Nevada, 89113
United States
Radiation Oncology Centers of Nevada Southeast
Las Vegas, Nevada, 89119
United States
Ann M Wierman MD LTD
Las Vegas, Nevada, 89128
United States
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada, 89128
United States
GenesisCare USA - Vegas Tenaya
Las Vegas, Nevada, 89128
United States
Las Vegas Urology - Cathedral Rock
Las Vegas, Nevada, 89128
United States
Las Vegas Urology - Smoke Ranch
Las Vegas, Nevada, 89128
United States
OptumCare Cancer Care at MountainView
Las Vegas, Nevada, 89128
United States
Urology Specialists of Nevada - Northwest
Las Vegas, Nevada, 89128
United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, 89135
United States
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas, Nevada, 89144
United States
Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas, Nevada, 89144
United States
Summerlin Hospital Medical Center
Las Vegas, Nevada, 89144
United States
Las Vegas Cancer Center-Medical Center
Las Vegas, Nevada, 89148-2405
United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89148
United States
GenesisCare USA - Fort Apache
Las Vegas, Nevada, 89148
United States
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, 89148
United States
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada, 89169
United States
Hope Cancer Care of Nevada-Pahrump
Pahrump, Nevada, 89048
United States
Renown Regional Medical Center
Reno, Nevada, 89502
United States
Saint Mary's Regional Medical Center
Reno, Nevada, 89503
United States
Radiation Oncology Associates
Reno, Nevada, 89509
United States
Northern Nevada Radiation Oncology
Reno, Nevada, 89521
United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Morristown Medical Center
Morristown, New Jersey, 07960
United States
Saint Peter's University Hospital
New Brunswick, New Jersey, 08901
United States
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903
United States
Saint Joseph's Regional Medical Center
Paterson, New Jersey, 07503
United States
Presbyterian Hospital
Albuquerque, New Mexico, 87106
United States
Albany Medical Center
Albany, New York, 12208
United States
Montefiore Medical Center-Einstein Campus
Bronx, New York, 10461
United States
Montefiore Medical Center-Weiler Hospital
Bronx, New York, 10461
United States
Children's Hospital at Montefiore
Bronx, New York, 10467
United States
Montefiore Medical Center - Moses Campus
Bronx, New York, 10467
United States
Maimonides Medical Center
Brooklyn, New York, 11219
United States
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, 11040
United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016
United States
Mount Sinai Hospital
New York, New York, 10029
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Stony Brook University Medical Center
Stony Brook, New York, 11794
United States
State University of New York Upstate Medical University
Syracuse, New York, 13210
United States
New York Medical College
Valhalla, New York, 10595
United States
Westchester Medical Center
Valhalla, New York, 10595
United States
Mission Hospital
Asheville, North Carolina, 28801
United States
Duke University Medical Center
Durham, North Carolina, 27710
United States
East Carolina University
Greenville, North Carolina, 27834
United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
United States
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
United States
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, 44106
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
Nationwide Children's Hospital
Columbus, Ohio, 43205
United States
Dayton Children's Hospital
Dayton, Ohio, 45404
United States
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo, Ohio, 43606
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
Legacy Emanuel Children's Hospital
Portland, Oregon, 97227
United States
Oregon Health and Science University
Portland, Oregon, 97239
United States
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103
United States
Geisinger Medical Center
Danville, Pennsylvania, 17822
United States
Penn State Children's Hospital
Hershey, Pennsylvania, 17033
United States
Saint Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134
United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
Prisma Health Richland Hospital
Columbia, South Carolina, 29203
United States
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, 29605
United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134
United States
East Tennessee Childrens Hospital
Knoxville, Tennessee, 37916
United States
Saint Jude Children's Research Hospital
Memphis, Tennessee, 38105
United States
The Children's Hospital at TriStar Centennial
Nashville, Tennessee, 37203
United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
United States
Texas Tech University Health Sciences Center-Amarillo
Amarillo, Texas, 79106
United States
Dell Children's Medical Center of Central Texas
Austin, Texas, 78723
United States
Driscoll Children's Hospital
Corpus Christi, Texas, 78411
United States
Medical City Dallas Hospital
Dallas, Texas, 75230
United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
United States
El Paso Children's Hospital
El Paso, Texas, 79905
United States
Cook Children's Medical Center
Fort Worth, Texas, 76104
United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77030
United States
M D Anderson Cancer Center
Houston, Texas, 77030
United States
Children's Hospital of San Antonio
San Antonio, Texas, 78207
United States
Methodist Children's Hospital of South Texas
San Antonio, Texas, 78229
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
United States
Primary Children's Hospital
Salt Lake City, Utah, 84113
United States
University of Vermont and State Agricultural College
Burlington, Vermont, 05405
United States
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042
United States
Children's Hospital of The King's Daughters
Norfolk, Virginia, 23507
United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
United States
Carilion Children's
Roanoke, Virginia, 24014
United States
Overlake Medical Center
Bellevue, Washington, 98004
United States
Valley Medical Center
Renton, Washington, 98055
United States
Seattle Children's Hospital
Seattle, Washington, 98105
United States
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, 99204
United States
Mary Bridge Children's Hospital and Health Center
Tacoma, Washington, 98405
United States
Madigan Army Medical Center
Tacoma, Washington, 98431
United States
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington, 98902
United States
West Virginia University Healthcare
Morgantown, West Virginia, 26506
United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792
United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Children's Oncology Group

  • John J Doski, PRINCIPAL_INVESTIGATOR, Children's Oncology Group

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-01
Study Completion Date2031-03-31

Study Record Updates

Study Start Date2022-04-01
Study Completion Date2031-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • Metastatic Malignant Neoplasm in the Lung
  • Metastatic Osteosarcoma
  • Osteosarcoma