Surveillance AFter Extremity Tumor surgerY

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).

Conditions

• Soft Tissue Sarcoma
• Lung Metastases

Interventions

OTHER

Frequency: Every 3 Months

every 3 months

OTHER

Frequency: Every 6 Months

every 6 months

OTHER

Imaging Modality: Chest Radiograph (CXR)

Chest radiograph (CXR)

OTHER

Imaging Modality: Chest CT

Chest computed tomography (CT)

Sponsors & Collaborators

• Hamilton Academic Health Sciences Organization

  collaborator OTHER

• Canadian Cancer Society (CCS)

  collaborator OTHER

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• American Academy of Orthopaedic Surgeons

  collaborator OTHER

• Musculoskeletal Tumor Society

  collaborator UNKNOWN

• McMaster University

  lead OTHER

Principal Investigators

• Michelle Ghert, MD · McMaster University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-11-19

Primary Completion

2027-12-31

Completion

2027-12-31

Countries

• United States
• Argentina
• Australia
• Austria
• Belgium
• Brazil
• Canada
• Germany
• Italy
• Malaysia
• Netherlands
• Portugal
• Spain
• Sweden

Study Locations