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Recruiting Phase 3

Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma

NCT05235165 · tracked via the Priya Life Science Australia tracker
Phase
Phase 3
Started
2022-04-01
Last updated
2026-08-25

Condition(s) studied

Metastatic Malignant Neoplasm in the LungMetastatic OsteosarcomaOsteosarcoma

Investigational drug(s) / intervention(s)

Biospecimen CollectionComputed TomographyQuestionnaire AdministrationThoracoscopyThoracotomy

Biospecimen Collection: Undergo collection of tissue and blood

Computed Tomography: Undergo CT

Questionnaire Administration: Ancillary studies

Thoracoscopy: Undergo video-assisted thoracoscopic surgery or VATS

Thoracotomy: Undergo open thoracic surgery

Study 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.

Eligibility

Sex
ALL
Min age
—
Max age
50 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Thoracic event-free survival (tEFS) — 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.

Trial sites (233)

FacilityCityRegionStatus
Children's Hospital of Alabama Birmingham Alabama Recruiting
Providence Alaska Medical Center Anchorage Alaska Recruiting
Kingman Regional Medical Center Kingman Arizona Recruiting
Banner Children's at Desert Mesa Arizona Recruiting
Phoenix Childrens Hospital Phoenix Arizona Recruiting
Banner University Medical Center - Tucson Tucson Arizona Recruiting
Arkansas Children's Hospital Little Rock Arkansas Recruiting
Kaiser Permanente-Anaheim Anaheim California Recruiting
PCR Oncology Arroyo Grande California Recruiting
Kaiser Permanente-Bellflower Bellflower California Recruiting
Kaiser Permanente Downey Medical Center Downey California Recruiting
Kaiser Permanente-Fontana Fontana California Recruiting
Loma Linda University Medical Center Loma Linda California Recruiting
Miller Children's and Women's Hospital Long Beach Long Beach California Recruiting
Children's Hospital Los Angeles Los Angeles California Recruiting
Kaiser Permanente Los Angeles Medical Center Los Angeles California Recruiting
Cedars-Sinai Medical Center Los Angeles California Recruiting
Valley Children's Hospital Madera California Recruiting
Kaiser Permanente-Oakland Oakland California Recruiting
Children's Hospital of Orange County Orange California Recruiting
Lucile Packard Children's Hospital Stanford University Palo Alto California Recruiting
University of California Davis Comprehensive Cancer Center Sacramento California Recruiting
Kaiser Permanente-San Diego Zion San Diego California Recruiting
Rady Children's Hospital - San Diego San Diego California Recruiting
UCSF Medical Center-Mission Bay San Francisco California Recruiting
Children's Hospital Colorado Aurora Colorado Recruiting
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver Colorado Recruiting
Connecticut Children's Medical Center Hartford Connecticut Recruiting
Smilow Cancer Center/Yale-New Haven Hospital New Haven Connecticut Recruiting
Yale University New Haven Connecticut Recruiting
Alfred I duPont Hospital for Children Wilmington Delaware Recruiting
Children's National Medical Center Washington D.C. District of Columbia Recruiting
Golisano Children's Hospital of Southwest Florida Fort Myers Florida Recruiting
UF Health Cancer Institute - Gainesville Gainesville Florida Active Not Recruiting
Nemours Children's Clinic-Jacksonville Jacksonville Florida Recruiting
Nicklaus Children's Hospital Miami Florida Recruiting
Arnold Palmer Hospital for Children Orlando Florida Recruiting
Nemours Children's Hospital Orlando Florida Recruiting
Johns Hopkins All Children's Hospital St. Petersburg Florida Recruiting
Tampa General Hospital Tampa Florida Recruiting

+ 193 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05235165 on ClinicalTrials.gov ↗ ← All trials in Australia