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Surveillance AFter Extremity Tumor surgerY (SAFETY) International Randomized Controlled Trial

Feasibility Research Objectives For the purposes of the pilot phase, the primary objective will be 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 STS surgery. To do so, we will assess: A) Our ability to recruit patients across multiple participating clinical sites; B) Our ability to ensure compliance with the study protocol, including the application of eligibility criteria, timing of intervention phase and post-intervention phase visits and imaging modality; C) Our ability to maintain completeness of follow-up data; D) Our ability to maintain completeness of cost analysis data; and E) Our ability to maintain data quality. Definitive Primary Research Objectives To determine the effect of surveillance strategy on patient survival following extremity STS surgery, we will answer the following questions: A) In extremity STS patients who undergo surgical excision with curative intent, what is the impact of surveillance frequency (every three vs. every six months) on overall survival at five years? B) In extremity STS patients who undergo surgical excision with curative intent, what is the impact of surveillance imaging modality (CXR vs. CT scan) on overall survival at five years? We hypothesize that: A) more frequent post-operative surveillance (when compared to less frequent post-operative surveillance); and B) the use of post-operative CT scans (when compared to CXR) in the first two years following the surgical excision of STS will improve survival over five years. Definitive Secondary Research Objectives The definitive study represents an excellent opportunity to investigate multiple secondary outcomes of interest. Therefore, we will also explore the effects of the post-operative surveillance strategies on a variety of patient-important and oncologic outcomes, as well as treatment-related complications and associated costs to the healthcare system. The secondary research objectives are outlined below. Patient-Important Outcomes In extremity STS patients who undergo surgical excision with curative intent, what is the impact of either surveillance frequency (every three vs. every six months) or imaging modality (CXR vs. CT scan) on patient anxiety, overall satisfaction and quality of life? Due to the increased time demands on participants allocated to every three-month surveillance frequency group, as well as the greater radiation dose in CT scans compared to CXR, we will administer validated questionnaires to assess patient anxiety, overall satisfaction and quality of life during their active surveillance period. Oncologic Outcomes In extremity STS patients who undergo surgical excision with curative intent, what is the impact of either surveillance frequency (every three vs. every six months) or imaging modality (CXR vs. CT scan) on: A) local recurrence-free survival (LRFS); and B) metastasis-free survival (MFS)? Treatment-Related Complications In extremity STS patients who undergo surgical excision with curative intent, what is the impact of either surveillance frequency (every three vs. every six months) or imaging modality (CXR vs. CT scan) on treatment-related complications (including chemotherapy-related complications, such as febrile neutropenia, fungal infections or sepsis, and thoracotomy-related complications, such as pneumothorax or surgical site infections)?

Feasibility Research Objectives For the purposes of the pilot phase, the primary objective will be 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 STS surgery. To do so, we will assess: A) Our ability to recruit patients across multiple participating clinical sites; B) Our ability to ensure compliance with the study protocol, including the application of eligibility criteria, timing of intervention phase and post-intervention phase visits and imaging modality; C) Our ability to maintain completeness of follow-up data; D) Our ability to maintain completeness of cost analysis data; and E) Our ability to maintain data quality. Definitive Primary Research Objectives To determine the effect of surveillance strategy on patient survival following extremity STS surgery, we will answer the following questions: A) In extremity STS patients who undergo surgical excision with curative intent, what is the impact of surveillance frequency (every three vs. every six months) on overall survival at five years? B) In extremity STS patients who undergo surgical excision with curative intent, what is the impact of surveillance imaging modality (CXR vs. CT scan) on overall survival at five years? We hypothesize that: A) more frequent post-operative surveillance (when compared to less frequent post-operative surveillance); and B) the use of post-operative CT scans (when compared to CXR) in the first two years following the surgical excision of STS will improve survival over five years. Definitive Secondary Research Objectives The definitive study represents an excellent opportunity to investigate multiple secondary outcomes of interest. Therefore, we will also explore the effects of the post-operative surveillance strategies on a variety of patient-important and oncologic outcomes, as well as treatment-related complications and associated costs to the healthcare system. The secondary research objectives are outlined below. Patient-Important Outcomes In extremity STS patients who undergo surgical excision with curative intent, what is the impact of either surveillance frequency (every three vs. every six months) or imaging modality (CXR vs. CT scan) on patient anxiety, overall satisfaction and quality of life? Due to the increased time demands on participants allocated to every three-month surveillance frequency group, as well as the greater radiation dose in CT scans compared to CXR, we will administer validated questionnaires to assess patient anxiety, overall satisfaction and quality of life during their active surveillance period. Oncologic Outcomes In extremity STS patients who undergo surgical excision with curative intent, what is the impact of either surveillance frequency (every three vs. every six months) or imaging modality (CXR vs. CT scan) on: A) local recurrence-free survival (LRFS); and B) metastasis-free survival (MFS)? Treatment-Related Complications In extremity STS patients who undergo surgical excision with curative intent, what is the impact of either surveillance frequency (every three vs. every six months) or imaging modality (CXR vs. CT scan) on treatment-related complications (including chemotherapy-related complications, such as febrile neutropenia, fungal infections or sepsis, and thoracotomy-related complications, such as pneumothorax or surgical site infections)?