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ACTIVE NOT RECRUITING
NCT03944798
NA

Surveillance AFter Extremity Tumor surgerY

Sponsor: McMaster University

View on ClinicalTrials.gov

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

Interventions

OTHER

Frequency: Every 3 Months

every 3 months

OTHER

Frequency: Every 6 Months

every 6 months

OTHER

Imaging Modality: Chest Radiograph (CXR)

Chest radiograph (CXR)

OTHER

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