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

Area of Science:

• Oncology
• Clinical Trials
• Medical Imaging

Background:

• Soft-tissue sarcomas (STSs) are rare cancers often treated with surgery and radiation.
• Pulmonary recurrence is common, necessitating post-operative surveillance.
• Current surveillance guidelines for STSs lack strong evidential support.

Purpose of the Study:

• To assess the feasibility of the Surveillance AFter Extremity Tumor SurgerY (SAFETY) randomized controlled trial.
• To evaluate the impact of surveillance frequency (3 vs. 6 months) and imaging modality (CXR vs. CT) on patient outcomes.
• To establish robust evidence for standardizing pulmonary surveillance in STS patients.

Main Methods:

• Pilot phase of the SAFETY randomized controlled trial.
• Enrolled 100 patients across 17 international sites.
• Assessed feasibility, protocol adherence, data quality, and 2-year outcomes.

Main Results:

• Achieved 85% progression criteria for follow-up, data completeness, and quality.
• 100 patients enrolled from 300 screened; minor protocol deviations noted.
• Identified patient outcomes including death, metastasis, local recurrence, and adverse events.

Conclusions:

• The SAFETY trial pilot demonstrated feasibility for patient enrollment and data quality.
• Confirmed the importance of emphasizing protocol adherence in sarcoma care.
• Results will inform standardized STS pulmonary surveillance, improving patient management.