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Surveillance AFter Extremity Tumor surgerY
Sponsor: McMaster University
Summary
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 randomized 310 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).
Official title: Surveillance AFter Extremity Tumor surgerY (SAFETY) International Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
310
Start Date
2019-11-19
Completion Date
2027-12
Last Updated
2024-11-22
Healthy Volunteers
No
Conditions
Interventions
Frequency: Every 3 Months
every 3 months
Frequency: Every 6 Months
every 6 months
Imaging Modality: Chest Radiograph (CXR)
Chest radiograph (CXR)
Imaging Modality: Chest CT
Chest computed tomography (CT)
Locations (35)
University of California Davis Medical Center
Sacramento, California, United States
Hartford HealthCare
Hartford, Connecticut, United States
University of Florida Health Shands Hospital
Gainesville, Florida, United States
UChicago Medicine
Chicago, Illinois, United States
Parkview Cancer Institute
Fort Wayne, Indiana, United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Albany Medical Center
Albany, New York, United States
NYU Langone Orthopaedic Hospital/Perlmutter Cancer Center
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Oregon Health and Science University Hospital
Portland, Oregon, United States
Allegheny Health Network Research Institute
Monroeville, Pennsylvania, United States
Texas Tech Health Sciences Center
El Paso, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Hospital Universitario Austral
Buenos Aires, Argentina
St. Vincent's Hospital Melbourne
Fitzroy, Melbourne, Australia
LKH - Universitätsklinikum Graz
Graz, Austria
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Hospital de Clínicas de Porto Alegre
Porto Alegre, Brazil
Nova Scotia Health
Halifax, Nova Scotia, Canada
Juravinski Hospital and Cancer Centre
Hamilton, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Hôtel Dieu du Quebec
Québec, Quebec, Canada
Helios Klinikum Berlin
Berlin, Germany
Centro Traumatologico Ortopedico Hospital
Turin, Italy
University Malaya Kuala Lumpur
Kuala Lumpur, Malaysia
Leiden University Medical Center
Leiden, Netherlands
Centro Hospitalar e Universitario de Coimbra
Coimbra, Portugal
Hospital Vall d'Hebron
Barcelona, Spain
Karolinska University Hospital
Stockholm, Sweden