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Clinical Trials in Germany / NCT03944798
Active, not recruiting Not applicable

Surveillance AFter Extremity Tumor surgerY

NCT03944798 · tracked via the Priya Life Science Germany tracker
Phase
Not applicable
Started
2019-11-19
Last updated
2024-11-22

Condition(s) studied

Soft Tissue SarcomaLung Metastases

Investigational drug(s) / intervention(s)

Frequency: Every 3 MonthsFrequency: Every 6 MonthsImaging Modality: Chest Radiograph (CXR)Imaging Modality: Chest CT

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)

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

Trial sites (35)

FacilityCityRegionStatus
University of California Davis Medical Center Sacramento California
Hartford HealthCare Hartford Connecticut
University of Florida Health Shands Hospital Gainesville Florida
UChicago Medicine Chicago Illinois
Parkview Cancer Institute Fort Wayne Indiana
Holden Comprehensive Cancer Center Iowa City Iowa
Dartmouth-Hitchcock Medical Center Lebanon New Hampshire
Albany Medical Center Albany New York
NYU Langone Orthopaedic Hospital/Perlmutter Cancer Center New York New York
Montefiore Medical Center The Bronx New York
Cleveland Clinic Cleveland Ohio
Oregon Health and Science University Hospital Portland Oregon
Allegheny Health Network Research Institute Monroeville Pennsylvania
Texas Tech Health Sciences Center El Paso Texas
Huntsman Cancer Institute Salt Lake City Utah
Fred Hutchinson Cancer Center Seattle Washington
Hospital Universitario Austral Buenos Aires Argentina
St. Vincent's Hospital Melbourne Fitzroy Melbourne
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
Juravinski Hospital and Cancer Centre Hamilton Ontario
The Ottawa Hospital Ottawa Ontario
Mount Sinai Hospital Toronto Ontario
Hôpital Maisonneuve-Rosemont Montreal Quebec
McGill University Health Centre Montreal Quebec
Hôtel Dieu du Quebec Québec Quebec
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

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03944798 on ClinicalTrials.gov ↗ ← All trials in Germany