Surveillance AFter Extremity Tumor surgerY (SAFETY)

STUDY OVERVIEW

The SAFETY study sponsored by McMaster University aims to evaluate the impact of surveillance strategies on overall survival in extremity soft-tissue sarcoma patients post-surgery by comparing surveillance frequency (every 3 vs. every 6 months) and imaging modality (CT scans vs. chest radiographs) through a large international randomized controlled trial. This trial addresses the need for evidence-based guidelines in post-treatment surveillance and aims to improve patient outcomes in sarcoma care.

STUDY GOALS

The goal of the SAFETY trial is to determine the optimal surveillance strategy, including frequency and imaging modality, to improve overall survival in extremity soft-tissue sarcoma patients post-surgery through a large international randomized controlled trial.

LOCATION

El Paso, Texas: Texas Tech Health Sciences Center at El Paso

INCLUSION CRITERIA

• Age 18 or older

• Diagnosed with grade II or III soft-tissue sarcoma (STS) in an extremity

• Underwent surgical removal of the tumor with no visible remaining disease

• Completed planned radiation and/or chemotherapy

• Tumor size ≥ 5 centimeters

• Provided informed consent

exclusion criteria

• Initial presentation with metastases

• Recent surgical removal of local recurrence

• Diagnosis of myxoid/round cell liposarcoma or extra-skeletal Ewing's sarcoma

• Previous diagnosis of genetic syndrome with increased cancer risk

• Life expectancy less than one year due to another condition

• Surveillance protocol not compatible with study

• Foreseen difficulties in follow-up

• Currently enrolled in another study

• Already enrolled in the SAFETY trial

additional notes

• Second CT scan may be needed for confirmation of false positives

• Different surveillance protocols for myxoid liposarcoma and extra-skeletal Ewing's sarcoma

• Limitations on CT scan use for individuals with genetic syndromes with increased cancer risk

For more information, visit ClinicalTrials.gov.