Neoplasms

All Conditions

Symptoms and General Pathology

Rare Diseases

Sarcoma

Neoplasm Metastasis

Neoplastic Processes

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

Clinical assessment and chest radiograph (CXR) every six months for two years

Clinical assessment and CXR every three months for two years

Clinical assessment and chest computed tomography (CT) every six months for two years

Clinical assessment and chest CT every three months for two years

Frequency: Every 3 Months

Frequency: Every 6 Months

Imaging Modality: Chest Radiograph (CXR)

Imaging Modality: Chest CT

Tricia Schneider

Tess Hudson

Steven Thorpe, MD

R. Lor Randall, MD

Emily Shearier

Adam Lindsay, MD

André Spiguel, MD

Ashley Romine

Christopher Johnson, MD, FACS

Benjamin Miller, MD, MS

Matthew DiCaprio, MD

David Geller, MD

Karim Masrouha, MD

Heather Keaney

Nathan Mesko, MD

Lukas Nystrom, MD

James Hayden, MD, PhD

Yee-Cheen Doung, MD

Kenneth Gundle, MD

Brianna Godinez

Rajiv Rajani, MD

Jacqueline Hart

Kevin Jones, MD

John Groundland, MD

Maria Platero

Felasfa Wodajo, MD

Mercedes Gunning

Marcos Galli Serra, MD

Angela Cochrane

Peter Choong, MD, FRACS

Andreas Leithner, MD

Marko Bergovec, MD

Julie Santos

Ricardo Becker, MD

Kelly Trask, MSc

David AJ Wilson, MD, FRCSC

Michael Biddulph, MD, FRCSC

Hadia Farrukh

Michelle Ghert, MD, FRCSC

Yusra Al Mosuli

Joel Werier, MD, FRCSC

Anthony Griffin

Peter Ferguson, MD,MSc,FRCSC

Kim Tsoi, MD,FRCSC

Jay Wunder, MD,PhD,FRCSC

Georges Bastille, MD

Marc Isler, MD

Sophie Mottard, MD

Robert Turcotte, MD

Annie Arteau, MD

Norbert Dion, MD

Simone De Meo, PhD

Michele Boffano, MD

Michiel van de Sande, MD

Following treatment for a primary extremity sarcoma, patients remain at risk for the development of local and systemic disease recurrence. Metastasis (distant recurrence) to the lung is the most frequent single location of disease recurrence in sarcoma patients, occurring in almost half of all patients. Therefore, careful post-operative surveillance is an integral element of patient care. However, the detection of metastases does not necessarily affect long-term survival and may negatively impact quality of life. Surveillance strategies have not been well researched and have been identified as the top research priority in the extremity sarcoma field. Using a 2X2 factorial design to maximize efficiency and reduce overall trial costs, the SAFETY trial will randomize 830 extremity soft-tissue sarcoma (STS) patients to determine the effect of surveillance strategy on overall patient survival after surgery for a STS of the extremity by comparing the effectiveness of both surveillance frequency (every 3 vs. every 6 months) and imaging modality (CT scans vs. chest radiographs).

Post-treatment STS surveillance is an integral element of patient care. Although earlier detection of metastatic disease may improve long-term survival, no study has yet provided definitive evidence to support this assumption. A thorough systematic review of the literature has identified only a single limited randomized controlled trial (RCT) evaluating this clinical question, and surveys of sarcoma surgeons have determined that surgeons typically follow their patients based on the way in which they were trained. 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 RCT is required. The investigators, therefore, propose the Surveillance AFter Extremity Tumor surgerY (SAFETY) trial. In preparation for the SAFETY trial, the SAFETY investigators have completed the following preparatory work: A) establishment of a worldwide research collaborative group that spans 6 continents; B) collection of data from international sarcoma patients to determine their perceptions of sarcoma surveillance and their willingness to participate in a study in which randomization will determine their follow-up protocols; and C) the organization of a large Protocol Development Meeting with international and multidisciplinary participation, including sarcoma patient involvement, where critical aspects of the protocol were discussed and finalized.

The international, multi-center SAFETY trial will determine the effect of surveillance strategy on overall patient survival after surgery for a STS of the extremity by comparing the effectiveness of both surveillance frequency (every 3 vs. every 6 months) and imaging modality (CT scans vs. chest radiographs). Ultimately, the SAFETY trial will provide the necessary evidence to develop evidence-based surveillance guidelines, and is poised to have a significant impact on the post-operative care and outcomes of extremity soft-tissue sarcoma patients.

2 x 2 factorial superiority randomized controlled trial

The local clinical team, site study personnel and participants cannot be blinded to the treatment allocation as the imaging modalities are visually distinguishable and these individuals will be required to arrange the booking of surveillance visits and imaging at their respective clinical site.

The Central Adjudication Committee (CAC) will be blinded to surveillance frequency; however, because the imaging modalities are visually distinguishable, the CAC cannot be blinded to imaging modality. The data analysts will, however, remain blinded throughout the trial and all interpretation of study results will be conducted in a blinded manner. Since the primary outcome (overall survival) is objective, a lack of blinding of study personnel and patients, and the incomplete blinding of outcome assessors, introduces minimal threats to validity.

Surveillance AFter Extremity Tumor surgerY

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

The PROMIS® Cancer-Anxiety instrument assesses self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness). The PROMIS® Cancer-Anxiety instrument is a computer adaptive test. A minimum of 4 questions must be answered. One's responses will guide the system's choice of the next question. The test will continue until either the standard error drops below a specified level or the participant has answered the maximum number of 12 questions (whichever comes first). Each question has 5 response options ranging in value from 1 to 5. To find the raw score, sum the values of the response to each question. The lowest possible raw score is 4 and the highest is 60. The raw score will then be converted into a standardized T-score for each participant using the applicable conversion table. A higher T-score represents a higher degree of anxiety.

The PROMIS® Satisfaction with Social Roles \& Activities instrument assesses satisfaction with performing one's usual social roles and activities (e.g., 'I am satisfied with my ability to participate in family activities'). This instrument is a computer adaptive test. A minimum of 4 questions must be answered. One's response will guide the system's choice of the next question. The test will continue until either the standard error drops below a specified level or the participant has answered the maximum number of 12 questions (whichever comes first). Each question has 5 response options ranging in value from 1 to 5. To find the raw score, sum the values of the response to each question. The lowest possible raw score is 4 and the highest possible raw score is 60. The raw score will then be converted into a standardized T-score for each participant using the applicable conversion table. A higher T-score represents a higher degree of satisfaction.

The validated EuroQol-5 Dimension 5-level (EQ-5D-5L) questionnaire measures generic health status and consists of 2 sections: the descriptive system and the Visual Analogue Scale (VAS). The descriptive system is comprised of 5 dimensions (mobility, self care, usual activities, pain / discomfort and anxiety / depression). Each question has 5 response options ranging in value from 1 to 5. To find the raw score, sum the values of the response to each question. The lowest possible raw score is 5 and the highest is 25. A lower raw score in the descriptive system represents fewer issues with each of the 5 domains. The VAS records a participant's self-rated health from 0 to 100 on a vertical VAS with endpoints labeled '100 - the best health you can imagine' and '0 - the worst health you can imagine'. The participant is asked to mark an 'X' on the scale and write the corresponding number, which is this section's raw score.

As measured by the length of time from the time of randomization that the participant survives with no detection of recurrent disease at the initial tumor site or operative field.

As measured by as the length of time from the time of randomization that the participant survives with no detection of systemic disease recurrence at any anatomic location.

Will include both chemotherapy-related complications, such as febrile neutropenia, fungal infections or sepsis, and thoracotomy-related complications, such as pneumothorax or surgical site infections.

Will include both the net costs of surveillance and costs incurred from metastasis treatment and metastasis treatment-related complications.

Hamilton Academic Health Sciences Organization

McMaster University

Spots Global Cancer Trial Database for frequency: every 3 months