Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma
Recruiting · NCT05235165 · Interventional (participants receive a specific treatment) · Lead sponsor: Children's Oncology Group
View the official record on ClinicalTrials.gov →Interventions studied
Biospecimen CollectionComputed TomographyQuestionnaire AdministrationThoracoscopyThoracotomy
What this trial is about
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.
Who can take part
Age range
Up to 50 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Patients must be \< 50 years at the time of enrollment.
- Patients must have =\< 4 nodules per lung consistent with or suspicious for metastases, with at least one of which being \>= 3 mm and all of which must be =\< 3 cm size.
- Note: Patient must have eligibility confirmed by rapid central imaging review.
- Lung nodules must be considered resectable by either open thoracotomy or thoracoscopic surgery. Determination of resectability is made by the institutional surgeon.
- Patients must have a histological diagnosis of osteosarcoma.
- Patients must have evidence of metastatic lung disease at the time of initial diagnosis, or at time of 1st recurrence following completion of therapy for initially localized disease.
- Patients with newly diagnosed disease must have completed successful gross tumor resection for their primary tumor or surgical local control of primary tumor must be planned to be performed simultaneously with thoracic surgery.
- Newly diagnosed patients must be receiving or recently completed (within 60 days) systemic therapy considered by the treating physician to be standard treatment for newly diagnosed osteosarcoma (eg, cisplatin-doxorubicin or ifosfamide-based drug regimens) at the time of enrollment on this study. Dose and drug modifications for toxicity do not exclude patients from participation.
- Patients at time of 1st recurrence must have completed systemic therapy for their initial primary tumor, considered by the treating physician to be standard treatment for newly diagnosed osteosarcoma (eg, cisplatin-doxorubicin or ifosfamide-based drug regimens) at the time of enrollment on this study. Dose and drug modifications for toxicity do not exclude patients from participation.
Exclusion criteria
- 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.
Where it is running
60 locations listed across 48 US states.
- 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 D.C., District of Columbia, United States
- Golisano Children's Hospital of Southwest Florida - Fort Myers, Florida, United States
- UF Health Cancer Institute - Gainesville - Gainesville, Florida, United States
- Nemours Children's Clinic-Jacksonville - Jacksonville, Florida, United States
- Nicklaus Children's Hospital - Miami, Florida, United States
- Arnold Palmer Hospital for Children - Orlando, Florida, United States
- Nemours Children's Hospital - Orlando, Florida, United States
- Johns Hopkins All Children's Hospital - St. 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 - Arthur M Blank Hospital - 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
- OSF Children's Hospital of Illinois - 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
- University of Maryland/Greenebaum Cancer Center - Baltimore, Maryland, United States
Showing 60 of 233 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →