Surveillance Strategies After Surgery for Soft Tissue Sarcoma

(SAFETY Trial)

Not currently recruiting at 38 trial locations

Overseen By Hadia Farrukh

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: McMaster University

Disqualifiers: Metastases, Local recurrence, Genetic syndromes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: Surgery and immediate recovery

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. ^{1 2 3 4 5}

Why 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. ^{2 6 7 8 9}

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

My tumor is at least 5 cm large according to my latest tests.

I had surgery to remove my cancer and the report shows no visible cancer left.

I have finished all my scheduled chemotherapy or radiation treatments.

Exclusion Criteria

The patient has already been enrolled in the SAFETY trial

I have a genetic condition that increases my cancer risk, so I limit CT scans.

My initial scans showed that my cancer has spread.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgery for extremity soft-tissue sarcoma (STS)

Surgery and immediate recovery

Surveillance

Participants are monitored post-surgery with varying surveillance strategies (every 3 vs. every 6 months) and imaging modalities (CT scans vs. chest radiographs)

2 years

Every 3 or 6 months, depending on randomization

Follow-up

Participants are monitored for safety and effectiveness after the surveillance period

1 year

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?

Group I: Surveillance Arm IV Experimental Treatment 2 Interventions

Clinical assessment and chest CT every three months for two years

Group II: Surveillance Arm III Experimental Treatment 2 Interventions

Clinical assessment and chest computed tomography (CT) every six months for two years

Group III: Surveillance Arm II Experimental Treatment 2 Interventions

Clinical assessment and CXR every three months for two years

Group IV: Surveillance Arm I Active Control 2 Interventions

Clinical assessment and chest radiograph (CXR) every six months for two years

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Canadian Cancer Society (CCS)

Collaborator

Trials

84

Recruited

42,100+

American Academy of Orthopaedic Surgeons

Collaborator

Trials

2

Recruited

430+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Musculoskeletal Tumor Society

Collaborator

Trials

2

Recruited

350+

Hamilton Academic Health Sciences Organization

Collaborator

Trials

22

Recruited

5,200+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6815708/

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.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03944798

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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6756324/

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.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0363018823000725

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 ...

5. nature.com nature.com/articles/s41598-024-57770-z

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.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3565411/

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 ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1040842825000496

Economic evaluations and health economic models of soft ... This study aimed to review the literature on economic evaluations and health economic models in STS.

8. surgoncinsight.org surgoncinsight.org/article/S2950-2470(25)00003-9/fulltext

Optimal surveillance for detecting sarcoma lung metastasis Based on data from the American Cancer Society, in 2024 there will be approximately 13,590 new cases of soft tissue sarcomas and 5200 deaths.

9. jto.org jto.org/article/S1556-0864(15)32422-9/fulltext

Soft Tissue Sarcomas of the Chest Wall The main purpose of this study was to evaluate the clinical outcomes for patients with chest wall soft tissue sarcomas.