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
- Diseases
- Lung cancer, Sarcoma
- 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
Sites (35)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario Austral Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| LKH - Universitätsklinikum Graz Coordinator of this site? Confirm its status | Graz | Austria | Unknown status |
| St Vincent's Hospital Melbourne Coordinator of this site? Confirm its status | Fitzroy | Australia | Unknown status |
| Cliniques universitaires Saint-Luc Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| Hospital de Clinicas de Porto Alegre Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Nova Scotia Health Coordinator of this site? Confirm its status | Halifax | Canada | Unknown status |
| Juravinski Hospital and Cancer Centre Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| McGill University Health Centre Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Hôpital Maisonneuve-Rosemont Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| The Ottawa Hospital Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| Hôtel Dieu du Quebec Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| Mount Sinai Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Helios Klinikum Berlin Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Hospital Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Centro Traumatologico Ortopedico Hospital Coordinator of this site? Confirm its status | Turin | Italy | Unknown status |
| University Malaya Kuala Lumpur Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Unknown status |
| Leiden University Medical Center Coordinator of this site? Confirm its status | Leiden | Netherlands | Unknown status |
| Centro Hospitalar e Universitario de Coimbra Coordinator of this site? Confirm its status | Coimbra | Portugal | Unknown status |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
| Albany Medical Center Coordinator of this site? Confirm its status | Albany | United States | Unknown status |
| UChicago Medicine Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Texas Tech Health Sciences Center Coordinator of this site? Confirm its status | El Paso | United States | Unknown status |
| Parkview Cancer Institute Coordinator of this site? Confirm its status | Fort Wayne | United States | Unknown status |
| University of Florida Health Shands Hospital Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| Hartford Healthcare Coordinator of this site? Confirm its status | Hartford | United States | Unknown status |
| Holden Comprehensive Cancer Center Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| Dartmouth Hitchcock Medical Center Coordinator of this site? Confirm its status | Lebanon | United States | Unknown status |
| Allegheny Health Network Research Institute Coordinator of this site? Confirm its status | Monroeville | United States | Unknown status |
| NYU Langone Orthopaedic Hospital/Perlmutter Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Oregon Health and Science University Hospital Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| University of California, Davis Medical Center Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| Huntsman Cancer Institute Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| Fred Hutchinson Cancer Center Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Montefiore Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.