What is the SAFETY trial?
Sarcomas are a rare group of cancers of connective tissue that most commonly occur in the extremities. These cancers are generally considered chemotherapy resistant, with radiation and surgical removal of the tumour the cornerstone of treatment. When the tumour is growing, cancer cells can get into the bloodstream and spread to other parts of the body, most commonly to the lungs (lung metastases); therefore, careful surveillance is required following treatment for sarcomas. Yet, there is clinical equipoise among orthopaedic oncologists regarding surveillance frequency and imaging modality. Regular, intensive surveillance may provide reassurance to patients and clinicians, as it is more likely to identify metastases earlier, than would less intense surveillance. Doctors look for lung metastases with either a chest x-ray (CXR), or CT scan of the chest. CT scans may identify smaller lesions as opposed to CXRs to further reassure patients. However, intensive surveillance also creates burdens on the healthcare system and patients, including both direct and indirect costs. Additionally, unnecessary radiation exposure is a concern with the use of CT scans due to its much higher radiation dosage than conventional diagnostic radiographs.
The orthopaedic oncology field has identified sarcoma surveillance strategy as the top research priority in the field. In order to fill the evidence gap in sarcoma surveillance, a large international randomized controlled trial (RCT) is required. We propose a study in which sarcoma patients will be assigned by chance (randomized) to more or less frequent lung imaging (3 months vs. 6 months) and to CT scans vs. CXRs. This will allow us to determine the most effective way to follow sarcoma patients in the clinic with respect to long-term survival. We will also ask patients about their anxiety when coming in to see the doctor.
The pilot phase of the SAFETY trial has commenced to determine whether it is feasible to conduct a large multi-center RCT that will evaluate the impact of surveillance strategies on patient survival following extremity soft-tissue sarcoma (STS) surgery. We plan to leverage our large international collaborative group from the PARITY trial, which involved 55 clinical sites across 12 countries and 6 continents, to answer the definitive SAFETY trial research question; Does the frequency and mode of surveillance affect patient survival following extremity STS surgery? The SAFETY team and Methods Centre welcome all investigators interested in participating in this exciting international research initiative to complete an investigator application form.