Surveillance Strategies After Surgery for Soft Tissue Sarcoma
(SAFETY Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the best ways to monitor individuals who have undergone surgery for soft tissue sarcoma, a cancer in the body's soft tissues. Researchers aim to determine which method and frequency of check-ups benefit patients most. They compare different schedules (every three months vs. every six months) and types of imaging tests (CT scans vs. chest X-rays) to identify the most effective approach for detecting cancer recurrence without impacting quality of life. The trial seeks participants who have had surgery to remove a soft-tissue sarcoma from their arms or legs and have completed any additional treatments, such as radiation or chemotherapy. As an unphased trial, this study provides a unique opportunity for patients to contribute to research that could improve post-surgery monitoring and potentially enhance quality of life.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
What prior data suggests that these surveillance strategies are safe for patients with soft tissue sarcoma?
Research has shown that chest X-rays and chest CT scans safely monitor patients after sarcoma surgery. Chest X-rays are easy to perform and typically cause no side effects, making them a common procedure in hospitals and clinics.
While CT scans use more radiation than X-rays, they remain safe when performed at recommended intervals. Studies on patients with sarcoma have not identified any major side effects from these imaging methods. Discussing options with a healthcare provider is crucial to determine the best approach for individual health needs.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it aims to pinpoint the most effective surveillance strategy after surgery for soft tissue sarcoma. Unlike the standard approach, which typically involves routine follow-ups without standardized imaging frequency, this trial compares different imaging schedules and modalities. By testing both chest X-rays and CT scans at varied intervals, the trial could lead to a more tailored surveillance plan, potentially improving early detection of recurrence and patient outcomes. This could mean more precise monitoring with possibly fewer unnecessary scans, reducing patient exposure to radiation and healthcare costs.
What evidence suggests that this trial's surveillance strategies could be effective for soft tissue sarcoma?
This trial will compare different surveillance strategies after sarcoma surgery. Research has shown that having a chest X-ray every three months, as in Surveillance Arm II of this trial, is as effective for survival as more frequent check-ups. Meanwhile, chest CT scans, part of Surveillance Arms III and IV, performed every three or six months, detect cancer spread to the lungs earlier. However, CT scans cost more and might not improve long-term survival. Although frequent CT scans can identify changes sooner, this doesn't always lead to longer life. Both chest X-rays and CT scans have advantages and disadvantages, and the choice often depends on balancing detection effectiveness, cost, and the patient's quality of life.26789
Who Is on the Research Team?
Michelle Ghert, MD
Principal Investigator
McMaster University
Are You a Good Fit for This Trial?
Adults over 18 who've had surgery for a large, high-grade soft-tissue sarcoma in an extremity without any remaining visible disease can join. They must have finished any radiation or chemo if it was part of their treatment and be able to consent. People with initial metastases, recent local recurrence surgeries, certain sarcoma subtypes, life expectancy under one year due to other diseases, incompatible surveillance protocols, enrollment in conflicting trials or genetic syndromes like Li-Freumeni are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo surgery for extremity soft-tissue sarcoma (STS)
Surveillance
Participants are monitored post-surgery with varying surveillance strategies (every 3 vs. every 6 months) and imaging modalities (CT scans vs. chest radiographs)
Follow-up
Participants are monitored for safety and effectiveness after the surveillance period
What Are the Treatments Tested in This Trial?
Interventions
- Frequency: Every 3 Months
- Frequency: Every 6 Months
- Imaging Modality: Chest CT
- Imaging Modality: Chest Radiograph (CXR)
Trial Overview
The SAFETY trial is testing how often patients should get check-ups (every 3 vs. every 6 months) and what type of imaging (CT scans vs. chest radiographs) is best after surgery for extremity soft-tissue sarcoma. It aims to see which strategy helps survival rates the most without negatively affecting quality of life.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Active Control
Clinical assessment and chest CT every three months for two years
Clinical assessment and chest computed tomography (CT) every six months for two years
Clinical assessment and CXR every three months for two years
Clinical assessment and chest radiograph (CXR) every six months for two years
Find a Clinic Near You
Who Is Running the Clinical Trial?
McMaster University
Lead Sponsor
Canadian Cancer Society (CCS)
Collaborator
American Academy of Orthopaedic Surgeons
Collaborator
Canadian Institutes of Health Research (CIHR)
Collaborator
Musculoskeletal Tumor Society
Collaborator
Hamilton Academic Health Sciences Organization
Collaborator
Citations
Lung Surveillance Strategy for High-Grade Soft Tissue ...
In this large multicenter study, LS with CXR did not result in worse overall survival when compared to CT.
NCT03944798 | Surveillance AFter Extremity Tumor surgerY
Surveillance Arm IV. Clinical assessment and chest CT every three months for two years. Intervention/Treatment, Other : Frequency: Every 3 Months. every 3 ...
The Surveillance After Extremity Tumor Surgery (SAFETY) trial
CXR every 3 months for 2 years;. CXR every 6 ... Surveillance strategies for patients following surgical resection of soft tissue sarcomas.
Imaging Utilization Patterns in the Follow-Up of Extremity ...
This study aimed to describe patterns of imaging utilization after resection of extremity soft tissue sarcoma in the United States, assess for potential ...
Ultra-low-dose computed tomography and chest X-ray in ...
ULD-CT was more sensitive than CXR in detecting pulmonary metastases in this prospective trial in patients with high grade soft tissue sarcoma.
CT Scans for Pulmonary Surveillance May Be Overused in ...
Chest CT scans are often used to monitor patients after excision of a sarcoma. Although sensitive, CT scans are more expensive than chest radiographs and ...
Economic evaluations and health economic models of soft ...
This study aimed to review the literature on economic evaluations and health economic models in STS.
Optimal surveillance for detecting sarcoma lung metastasis
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The main purpose of this study was to evaluate the clinical outcomes for patients with chest wall soft tissue sarcomas.
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