Surveillance AFter Extremity Tumor surgerY

Running, not enrolling · Not applicable

Conditions studied: Soft Tissue Sarcoma, Lung Metastases

In brief

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).

Key facts

Study ID

NCT03944798

Run by

McMaster University

People needed

310

Starts

2019-11-19

Expected to finish

2027-12-01

Last updated by the study team

2024-11-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The patient is 18 years of age or older;
• The patient has been diagnosed with a primary extremity grade II or III soft-tissue sarcoma (STS);
• The patient has undergone surgical excision of the tumor with curative intent and with no evidence of gross residual disease based on the pathology report;
• The patient has completed all planned neoadjuvant or adjuvant radiation and / or chemotherapy, if applicable;
• The tumor size is greater than or equal to (≥) five centimeters according to the pathology report or based on the pre-treatment MRI if neoadjuvant radiation and / or chemotherapy are given; and
• The patient provides informed consent.

You may not qualify if…

• The patient has metastases at initial presentation based on the radiology report of the initial thoracic imaging†;
• The patient has recently undergone surgical excision of a local recurrence;
• The patient has been diagnosed with one of the special sub-types, myxoid / round cell liposarcoma or extra-skeletal Ewing's sarcoma*;
• The patient has been previously diagnosed with a genetic syndrome with an elevated risk of malignancy, such as Li-Freumeni Syndrome‡;
• The patient has been previously diagnosed with a co-morbid condition that has a life expectancy of less than (<) one year;
• The site-specific surveillance protocol for the patient's disease is not compatible with the study protocol (i.e., regular planned whole-body imaging with positron emission tomography [PET] scans);
• Likely problems, in the judgment of the investigator, with the patient maintaining follow-up (with the specific reasoning requiring approval of the Methods Center);
• The patient is currently enrolled in a study that does not permit co-enrolment; and
• The patient has already been enrolled in the SAFETY trial.
• A second CT scan may be required to confirm that indeterminate nodules are false positives before the patient can be enrolled (provided that the second CT scan shows no evidence of metastatic disease);
• Myxoid liposarcoma and extra-skeletal Ewing's sarcoma have different metastatic patterns, which necessitate different surveillance protocols;
• Individuals with Li-Freumeni Syndrome, or other genetic syndromes with an elevated risk of malignancy, appear to be at an elevated risk for radiation-induced cancers, so the use of CT scans should be limited.

Where it is running

• 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

Full record on ClinicalTrials.gov

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