The Surveillance After Extremity Tumor Surgery (SAFETY) Pilot International Multi-Center Randomized Controlled Trial

Soft-tissue sarcomas (STSs) are rare malignancies predominantly found in the extremities. Surgery and radiation are standard treatments, but post-operative pulmonary surveillance, involving clinical visits and thoracic imaging, is crucial due to a high recurrence rate, most commonly to the lungs. Current pulmonary surveillance guidelines lack robust evidence. The Surveillance AFter Extremity Tumor SurgerY (SAFETY) randomized controlled trial is designed to determine the impact of pulmonary surveillance frequency (every three versus six months) and chest imaging modality (CXR versus CT) on patient-important outcomes. The pilot phase assessed feasibility of patient enrolment, protocol adherence, and data quality, as well as aggregate outcomes at two years of follow-up. 100 patients were enrolled from 300 screened patients across 17 international sites. Minor protocol deviations were common. Follow-up, data completeness and data quality met the progression criteria of 85%. Of the 100 patients, 15 died, 21 had metastases, seven had local recurrence and 30 experienced at least one serious adverse event. This SAFETY trial study established feasibility of enrolment and data quality, and confirmed the need to emphasize protocol adherence in sarcoma care. The results of this trial are expected to provide crucial evidence to standardize STS pulmonary surveillance practices, ultimately improving patient management and expectations.