Surveillance AFter Extremity Tumor surgerY

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).

Ask AI to explain this study

Start here

Key things to know

Main goalPrevention

This describes the study’s primary purpose.

What is being studiedFrequency: Every 3 Months and Frequency: Every 6 Months

Plus 2 other study approaches.

Who it may be forRecurrent or relapsed

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Nov 22, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Not applicable

Interventional

Where is it offered?35 U.S. locations

Locations may change over time.

Who runs it?McMaster University

Study sponsor

Study overview

What this study is about

Purpose: Prevention
Study type: Interventional
Phase: Not applicable
Sponsor: McMaster University
Interventions being studied: Other: Frequency: Every 3 Months; Other: Frequency: Every 6 Months; Other: Imaging Modality: Chest Radiograph (CXR); Other: Imaging Modality: Chest CT

Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Disease setting

Recurrent or relapsed→

Treatment approach

Surgery→

Study topics

After surgery (adjuvant)→Survivorship and quality of life→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

University of California Davis Medical CenterSacramento, California
Hartford HealthCareHartford, Connecticut
University of Florida Health Shands HospitalGainesville, Florida
UChicago MedicineChicago, Illinois
Parkview Cancer InstituteFort Wayne, Indiana
Holden Comprehensive Cancer CenterIowa City, Iowa
Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire
Albany Medical CenterAlbany, New York
NYU Langone Orthopaedic Hospital/Perlmutter Cancer CenterNew York, New York
Montefiore Medical CenterThe Bronx, New York
Cleveland ClinicCleveland, Ohio
Oregon Health and Science University HospitalPortland, Oregon

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 22, 2024. Always confirm current availability with the study team.

View original record ↗