AOST2031. A Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients with Osteosarcoma.
Categories (click each to see list of all clinical trials associated with that category): Pediatric (PEDONC)
Current Status: Open
Phase: III (Cancer Control)
Principal Investigator: Beck, Jill
Contact Information:
Angie Boettner
aboettner@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT05235165?term=NCT05235165&rank=1
Summary
Primary Outcome Measures :
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. 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.
Secondary Outcome Measures :
Event free survival (EFS) [ Time Frame: Four years after enrollment ]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.
Overall survival (OS) [ Time Frame: Four years after enrollment ]
Time from study enrollment to death or last patient contact. Patients alive at last contact are considered censored.
Post operative pain interference at time point 3, 7-14 days after surgical intervention [ Time Frame: 7-14 days after surgical intervention ]
Total PROMIS pain interference score from the 8 item PROMIS pain interference short form.
Post operative pain interference at time point 4, 4-6 weeks after surgical intervention [ Time Frame: 4-6 weeks after surgical intervention ]
Total PROMIS pain interference score from the 8 item PROMIS pain interference short form.