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Spots Global Cancer Trial Database for Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma

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Trial Identification

Brief Title: Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma

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

Study ID: NCT05235165

Study Description

Brief 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). 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: I. 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: I. 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. III. To determine if thoracoscopy is superior to open surgical resection for post-operative pain interference in patients with resectable oligometastatic pulmonary osteosarcoma. EXPLORATORY OBJECTIVES: I. 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. V. 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 prospectively compare between treatment arms the relationship between surgical approach and patient-reported outcomes (PROs), specifically patient functional impairment of the upper extremities, pain intensity, and health-related quality of life (HRQoL). VII. To generate well-characterized, clinically-annotated, distributable models of metastatic osteosarcoma. VIII. 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.

Keywords

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Children's Hospital of Alabama, Birmingham, Alabama, United States

Providence Alaska Medical Center, Anchorage, Alaska, United States

Kingman Regional Medical Center, Kingman, Arizona, United States

Banner Children's at Desert, Mesa, Arizona, United States

Phoenix Childrens Hospital, Phoenix, Arizona, United States

Banner University Medical Center - Tucson, Tucson, Arizona, United States

Arkansas Children's Hospital, Little Rock, Arkansas, United States

Kaiser Permanente-Anaheim, Anaheim, California, United States

PCR Oncology, Arroyo Grande, California, United States

Kaiser Permanente-Bellflower, Bellflower, California, United States

Kaiser Permanente Downey Medical Center, Downey, California, United States

Kaiser Permanente-Fontana, Fontana, California, United States

Loma Linda University Medical Center, Loma Linda, California, United States

Miller Children's and Women's Hospital Long Beach, Long Beach, California, United States

Children's Hospital Los Angeles, Los Angeles, California, United States

Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, United States

Cedars Sinai Medical Center, Los Angeles, California, United States

Valley Children's Hospital, Madera, California, United States

Kaiser Permanente-Oakland, Oakland, California, United States

Children's Hospital of Orange County, Orange, California, United States

Lucile Packard Children's Hospital Stanford University, Palo Alto, California, United States

University of California Davis Comprehensive Cancer Center, Sacramento, California, United States

Kaiser Permanente-San Diego Zion, San Diego, California, United States

Rady Children's Hospital - San Diego, San Diego, California, United States

UCSF Medical Center-Mission Bay, San Francisco, California, United States

Children's Hospital Colorado, Aurora, Colorado, United States

Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center, Denver, Colorado, United States

Connecticut Children's Medical Center, Hartford, Connecticut, United States

Smilow Cancer Center/Yale-New Haven Hospital, New Haven, Connecticut, United States

Yale University, New Haven, Connecticut, United States

Alfred I duPont Hospital for Children, Wilmington, Delaware, United States

Children's National Medical Center, Washington, District of Columbia, United States

Golisano Children's Hospital of Southwest Florida, Fort Myers, Florida, United States

University of Florida Health Science Center - Gainesville, Gainesville, Florida, United States

Nemours Children's Clinic-Jacksonville, Jacksonville, Florida, United States

Nicklaus Children's Hospital, Miami, Florida, United States

Nemours Children's Hospital, Orlando, Florida, United States

Johns Hopkins All Children's Hospital, Saint Petersburg, Florida, United States

Tampa General Hospital, Tampa, Florida, United States

Saint Joseph's Hospital/Children's Hospital-Tampa, Tampa, Florida, United States

Children's Healthcare of Atlanta - Egleston, Atlanta, Georgia, United States

Kapiolani Medical Center for Women and Children, Honolulu, Hawaii, United States

Saint Luke's Cancer Institute - Boise, Boise, Idaho, United States

Lurie Children's Hospital-Chicago, Chicago, Illinois, United States

University of Illinois, Chicago, Illinois, United States

University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States

Loyola University Medical Center, Maywood, Illinois, United States

Saint Jude Midwest Affiliate, Peoria, Illinois, United States

Northwestern Medicine Central DuPage Hospital, Winfield, Illinois, United States

Riley Hospital for Children, Indianapolis, Indiana, United States

Blank Children's Hospital, Des Moines, Iowa, United States

University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, United States

University of Kentucky/Markey Cancer Center, Lexington, Kentucky, United States

Norton Children's Hospital, Louisville, Kentucky, United States

Children's Hospital New Orleans, New Orleans, Louisiana, United States

Ochsner Medical Center Jefferson, New Orleans, Louisiana, United States

Eastern Maine Medical Center, Bangor, Maine, United States

Maine Children's Cancer Program, Scarborough, Maine, United States

Sinai Hospital of Baltimore, Baltimore, Maryland, United States

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States

Walter Reed National Military Medical Center, Bethesda, Maryland, United States

Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

C S Mott Children's Hospital, Ann Arbor, Michigan, United States

Bronson Battle Creek, Battle Creek, Michigan, United States

Children's Hospital of Michigan, Detroit, Michigan, United States

Michigan State University Clinical Center, East Lansing, Michigan, United States

Helen DeVos Children's Hospital at Spectrum Health, Grand Rapids, Michigan, United States

Spectrum Health at Butterworth Campus, Grand Rapids, Michigan, United States

Trinity Health Grand Rapids Hospital, Grand Rapids, Michigan, United States

Bronson Methodist Hospital, Kalamazoo, Michigan, United States

West Michigan Cancer Center, Kalamazoo, Michigan, United States

Ascension Borgess Cancer Center, Kalamazoo, Michigan, United States

Borgess Medical Center, Kalamazoo, Michigan, United States

Trinity Health Muskegon Hospital, Muskegon, Michigan, United States

Corewell Health Lakeland Hospitals - Niles Hospital, Niles, Michigan, United States

Cancer and Hematology Centers of Western Michigan - Norton Shores, Norton Shores, Michigan, United States

Corewell Health Reed City Hospital, Reed City, Michigan, United States

Beaumont Children's Hospital-Royal Oak, Royal Oak, Michigan, United States

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center, Saint Joseph, Michigan, United States

Lakeland Medical Center Saint Joseph, Saint Joseph, Michigan, United States

Munson Medical Center, Traverse City, Michigan, United States

University of Michigan Health - West, Wyoming, Michigan, United States

Children's Hospitals and Clinics of Minnesota - Minneapolis, Minneapolis, Minnesota, United States

University of Minnesota/Masonic Cancer Center, Minneapolis, Minnesota, United States

Mayo Clinic in Rochester, Rochester, Minnesota, United States

University of Mississippi Medical Center, Jackson, Mississippi, United States

Columbia Regional, Columbia, Missouri, United States

Children's Mercy Hospitals and Clinics, Kansas City, Missouri, United States

Cardinal Glennon Children's Medical Center, Saint Louis, Missouri, United States

Washington University School of Medicine, Saint Louis, Missouri, United States

Mercy Hospital Saint Louis, Saint Louis, Missouri, United States

Children's Hospital and Medical Center of Omaha, Omaha, Nebraska, United States

University of Nebraska Medical Center, Omaha, Nebraska, United States

Carson Tahoe Regional Medical Center, Carson City, Nevada, United States

Comprehensive Cancer Centers of Nevada - Henderson, Henderson, Nevada, United States

Comprehensive Cancer Centers of Nevada-Horizon Ridge, Henderson, Nevada, United States

Las Vegas Cancer Center-Henderson, Henderson, Nevada, United States

OptumCare Cancer Care at Seven Hills, Henderson, Nevada, United States

Comprehensive Cancer Centers of Nevada-Southeast Henderson, Henderson, Nevada, United States

GenesisCare USA - Henderson, Henderson, Nevada, United States

Las Vegas Urology - Green Valley, Henderson, Nevada, United States

Las Vegas Urology - Pebble, Henderson, Nevada, United States

Urology Specialists of Nevada - Green Valley, Henderson, Nevada, United States

Las Vegas Urology - Pecos, Las Vegas, Nevada, United States

OptumCare Cancer Care at Charleston, Las Vegas, Nevada, United States

University Medical Center of Southern Nevada, Las Vegas, Nevada, United States

Hope Cancer Care of Nevada, Las Vegas, Nevada, United States

Radiation Oncology Centers of Nevada Central, Las Vegas, Nevada, United States

Urology Specialists of Nevada - Central, Las Vegas, Nevada, United States

GenesisCare USA - Las Vegas, Las Vegas, Nevada, United States

Sunrise Hospital and Medical Center, Las Vegas, Nevada, United States

Las Vegas Urology - Sunset, Las Vegas, Nevada, United States

Urology Specialists of Nevada - Southwest, Las Vegas, Nevada, United States

Radiation Oncology Centers of Nevada Southeast, Las Vegas, Nevada, United States

Ann M Wierman MD LTD, Las Vegas, Nevada, United States

Comprehensive Cancer Centers of Nevada - Northwest, Las Vegas, Nevada, United States

GenesisCare USA - Vegas Tenaya, Las Vegas, Nevada, United States

Las Vegas Urology - Cathedral Rock, Las Vegas, Nevada, United States

Las Vegas Urology - Smoke Ranch, Las Vegas, Nevada, United States

OptumCare Cancer Care at MountainView, Las Vegas, Nevada, United States

Urology Specialists of Nevada - Northwest, Las Vegas, Nevada, United States

Alliance for Childhood Diseases/Cure 4 the Kids Foundation, Las Vegas, Nevada, United States

Comprehensive Cancer Centers of Nevada - Town Center, Las Vegas, Nevada, United States

Comprehensive Cancer Centers of Nevada-Summerlin, Las Vegas, Nevada, United States

Summerlin Hospital Medical Center, Las Vegas, Nevada, United States

Las Vegas Cancer Center-Medical Center, Las Vegas, Nevada, United States

Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States

GenesisCare USA - Fort Apache, Las Vegas, Nevada, United States

OptumCare Cancer Care at Fort Apache, Las Vegas, Nevada, United States

Comprehensive Cancer Centers of Nevada - Central Valley, Las Vegas, Nevada, United States

Hope Cancer Care of Nevada-Pahrump, Pahrump, Nevada, United States

Renown Regional Medical Center, Reno, Nevada, United States

Saint Mary's Regional Medical Center, Reno, Nevada, United States

Radiation Oncology Associates, Reno, Nevada, United States

Northern Nevada Radiation Oncology, Reno, Nevada, United States

Hackensack University Medical Center, Hackensack, New Jersey, United States

Morristown Medical Center, Morristown, New Jersey, United States

Saint Peter's University Hospital, New Brunswick, New Jersey, United States

Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital, New Brunswick, New Jersey, United States

Saint Joseph's Regional Medical Center, Paterson, New Jersey, United States

Albany Medical Center, Albany, New York, United States

Montefiore Medical Center-Einstein Campus, Bronx, New York, United States

Montefiore Medical Center-Weiler Hospital, Bronx, New York, United States

Children's Hospital at Montefiore, Bronx, New York, United States

Montefiore Medical Center - Moses Campus, Bronx, New York, United States

Maimonides Medical Center, Brooklyn, New York, United States

The Steven and Alexandra Cohen Children's Medical Center of New York, New Hyde Park, New York, United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York, New York, United States

Mount Sinai Hospital, New York, New York, United States

Memorial Sloan Kettering Cancer Center, New York, New York, United States

Stony Brook University Medical Center, Stony Brook, New York, United States

State University of New York Upstate Medical University, Syracuse, New York, United States

New York Medical College, Valhalla, New York, United States

Westchester Medical Center, Valhalla, New York, United States

Mission Hospital, Asheville, North Carolina, United States

Duke University Medical Center, Durham, North Carolina, United States

East Carolina University, Greenville, North Carolina, United States

Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States

Sanford Broadway Medical Center, Fargo, North Dakota, United States

Children's Hospital Medical Center of Akron, Akron, Ohio, United States

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States

Rainbow Babies and Childrens Hospital, Cleveland, Ohio, United States

Cleveland Clinic Foundation, Cleveland, Ohio, United States

Nationwide Children's Hospital, Columbus, Ohio, United States

Dayton Children's Hospital, Dayton, Ohio, United States

ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital, Toledo, Ohio, United States

University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States

Legacy Emanuel Children's Hospital, Portland, Oregon, United States

Oregon Health and Science University, Portland, Oregon, United States

Lehigh Valley Hospital-Cedar Crest, Allentown, Pennsylvania, United States

Geisinger Medical Center, Danville, Pennsylvania, United States

Penn State Children's Hospital, Hershey, Pennsylvania, United States

Saint Christopher's Hospital for Children, Philadelphia, Pennsylvania, United States

Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States

Rhode Island Hospital, Providence, Rhode Island, United States

Prisma Health Richland Hospital, Columbia, South Carolina, United States

BI-LO Charities Children's Cancer Center, Greenville, South Carolina, United States

Sanford USD Medical Center - Sioux Falls, Sioux Falls, South Dakota, United States

East Tennessee Childrens Hospital, Knoxville, Tennessee, United States

Saint Jude Children's Research Hospital, Memphis, Tennessee, United States

The Children's Hospital at TriStar Centennial, Nashville, Tennessee, United States

Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, United States

Texas Tech University Health Sciences Center-Amarillo, Amarillo, Texas, United States

Dell Children's Medical Center of Central Texas, Austin, Texas, United States

Driscoll Children's Hospital, Corpus Christi, Texas, United States

Medical City Dallas Hospital, Dallas, Texas, United States

UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States

El Paso Children's Hospital, El Paso, Texas, United States

Cook Children's Medical Center, Fort Worth, Texas, United States

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center, Houston, Texas, United States

M D Anderson Cancer Center, Houston, Texas, United States

Children's Hospital of San Antonio, San Antonio, Texas, United States

Methodist Children's Hospital of South Texas, San Antonio, Texas, United States

University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States

Primary Children's Hospital, Salt Lake City, Utah, United States

University of Vermont and State Agricultural College, Burlington, Vermont, United States

University of Virginia Cancer Center, Charlottesville, Virginia, United States

Inova Fairfax Hospital, Falls Church, Virginia, United States

Children's Hospital of The King's Daughters, Norfolk, Virginia, United States

Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, United States

Carilion Children's, Roanoke, Virginia, United States

Overlake Medical Center, Bellevue, Washington, United States

Valley Medical Center, Renton, Washington, United States

Seattle Children's Hospital, Seattle, Washington, United States

Providence Sacred Heart Medical Center and Children's Hospital, Spokane, Washington, United States

Mary Bridge Children's Hospital and Health Center, Tacoma, Washington, United States

Madigan Army Medical Center, Tacoma, Washington, United States

North Star Lodge Cancer Center at Yakima Valley Memorial Hospital, Yakima, Washington, United States

West Virginia University Healthcare, Morgantown, West Virginia, United States

University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, United States

Marshfield Medical Center-Marshfield, Marshfield, Wisconsin, United States

Children's Hospital of Wisconsin, Milwaukee, Wisconsin, United States

The Children's Hospital at Westmead, Westmead, New South Wales, Australia

Royal Children's Hospital, Parkville, Victoria, Australia

Perth Children's Hospital, Perth, Western Australia, Australia

Alberta Children's Hospital, Calgary, Alberta, Canada

University of Alberta Hospital, Edmonton, Alberta, Canada

IWK Health Centre, Halifax, Nova Scotia, Canada

The Montreal Children's Hospital of the MUHC, Montreal, Quebec, Canada

Centre Hospitalier Universitaire Sainte-Justine, Montreal, Quebec, Canada

Centre Hospitalier Universitaire de Sherbrooke-Fleurimont, Sherbrooke, Quebec, Canada

Starship Children's Hospital, Grafton, Auckland, New Zealand

Christchurch Hospital, Christchurch, , New Zealand

HIMA San Pablo Oncologic Hospital, Caguas, , Puerto Rico

King Faisal Specialist Hospital and Research Centre, Riyadh, , Saudi Arabia

Contact Details

Name: John J Doski

Affiliation: Children's Oncology Group

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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