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NCT03944798Active, not recruiting

Surveillance AFter Extremity Tumor surgerY

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

Source: ClinicalTrials.gov · Last updated 22 Nov 2024

Brief summary (registry, in English)

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).

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
310 (actual)
First submitted
7 May 2019
Start date
19 Nov 2019
Primary completion date
Dec 2027
Lead sponsor
McMaster University
NCT number
NCT03944798

What you commit to

  • Study type: Interventional
  • Participants enrolled: 310
  • From 19 Nov 2019 to the primary completion date, Dec 2027
  • 35 sites in 14 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • The patient has recently undergone surgical excision of a local recurrence;
  • 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;

Other illness

  • 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);
  • 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.

Other

  • The patient has metastases at initial presentation based on the radiology report of the initial thoracic imaging†;
  • The patient has been diagnosed with one of the special sub-types, myxoid / round cell liposarcoma or extra-skeletal Ewing's sarcoma\*;
  • 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

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (35)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Universitario Austral
Coordinator of this site? Confirm its status
Buenos AiresArgentinaUnknown status
LKH - Universitätsklinikum Graz
Coordinator of this site? Confirm its status
GrazAustriaUnknown status
St Vincent's Hospital Melbourne
Coordinator of this site? Confirm its status
FitzroyAustraliaUnknown status
Cliniques universitaires Saint-Luc
Coordinator of this site? Confirm its status
BrusselsBelgiumUnknown status
Hospital de Clinicas de Porto Alegre
Coordinator of this site? Confirm its status
Porto AlegreBrazilUnknown status
Nova Scotia Health
Coordinator of this site? Confirm its status
HalifaxCanadaUnknown status
Juravinski Hospital and Cancer Centre
Coordinator of this site? Confirm its status
HamiltonCanadaUnknown status
McGill University Health Centre
Coordinator of this site? Confirm its status
MontrealCanadaUnknown status
Hôpital Maisonneuve-Rosemont
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MontrealCanadaUnknown status
The Ottawa Hospital
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OttawaCanadaUnknown status
Hôtel Dieu du Quebec
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QuébecCanadaUnknown status
Mount Sinai Hospital
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TorontoCanadaUnknown status
Helios Klinikum Berlin
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BerlinGermanyUnknown status
Hospital Vall d'Hebron
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BarcelonaSpainUnknown status
Centro Traumatologico Ortopedico Hospital
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TurinItalyUnknown status
University Malaya Kuala Lumpur
Coordinator of this site? Confirm its status
Kuala LumpurMalaysiaUnknown status
Leiden University Medical Center
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LeidenNetherlandsUnknown status
Centro Hospitalar e Universitario de Coimbra
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CoimbraPortugalUnknown status
Karolinska University Hospital
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StockholmSwedenUnknown status
Albany Medical Center
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AlbanyUnited StatesUnknown status
UChicago Medicine
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ChicagoUnited StatesUnknown status
Cleveland Clinic
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ClevelandUnited StatesUnknown status
Texas Tech Health Sciences Center
Coordinator of this site? Confirm its status
El PasoUnited StatesUnknown status
Parkview Cancer Institute
Coordinator of this site? Confirm its status
Fort WayneUnited StatesUnknown status
University of Florida Health Shands Hospital
Coordinator of this site? Confirm its status
GainesvilleUnited StatesUnknown status
Hartford Healthcare
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HartfordUnited StatesUnknown status
Holden Comprehensive Cancer Center
Coordinator of this site? Confirm its status
Iowa CityUnited StatesUnknown status
Dartmouth Hitchcock Medical Center
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LebanonUnited StatesUnknown status
Allegheny Health Network Research Institute
Coordinator of this site? Confirm its status
MonroevilleUnited StatesUnknown status
NYU Langone Orthopaedic Hospital/Perlmutter Cancer Center
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Oregon Health and Science University Hospital
Coordinator of this site? Confirm its status
PortlandUnited StatesUnknown status
University of California, Davis Medical Center
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SacramentoUnited StatesUnknown status
Huntsman Cancer Institute
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Salt Lake CityUnited StatesUnknown status
Fred Hutchinson Cancer Center
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SeattleUnited StatesUnknown status
Montefiore Medical Center
Coordinator of this site? Confirm its status
The BronxUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.