Surveillance Strategies After Surgery for Soft Tissue Sarcoma

(SAFETY Trial)

Recruiting at 35 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

310 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

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 data supports the effectiveness of this treatment for soft tissue sarcoma?

The research suggests that regular follow-up with chest X-rays (CXR) or CT scans is recommended for monitoring lung metastases in high-grade soft tissue sarcoma, as these are common sites for cancer spread. However, there is limited evidence on the best frequency and type of imaging, and the guidelines allow flexibility to tailor the approach to individual patient needs. ^{1 2 3 4 5}

Is it safe to use chest X-ray or CT scan for follow-up after soft tissue sarcoma surgery?

Chest X-rays and CT scans are generally safe for follow-up after soft tissue sarcoma surgery, with chest X-rays involving lower radiation exposure over time. However, the choice between them depends on factors like tumor grade and risk of lung metastases. ^{1 3 4 5 6}

How is the surveillance strategy after surgery for soft tissue sarcoma different from other treatments?

The surveillance strategy after surgery for soft tissue sarcoma is unique because it focuses on personalized follow-up schedules based on the risk of recurrence and the biology of the disease, rather than a one-size-fits-all approach. This strategy involves regular clinical assessments and imaging, such as chest X-rays or CT scans, to monitor for lung metastases, which are common in high-grade sarcomas. ^{1 2 7 8 9}

Research Team

Michelle Ghert, MD

Principal Investigator

McMaster University

Eligibility Criteria

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 am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Lung Surveillance Strategy for High-Grade Soft Tissue Sarcomas: Chest X-Ray or CT Scan? [2020]

2. United States pubmed.ncbi.nlm.nih.gov

How long should we follow patients with soft tissue sarcomas? [2021]

3. England pubmed.ncbi.nlm.nih.gov

Is routine chest radiography a useful test in the follow up of all adult patients with soft tissue sarcoma? [2016]

4. Japan pubmed.ncbi.nlm.nih.gov

Effective utilization of chest X-ray for follow-up of metastatic lung tumor due to soft tissue sarcoma. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Sarcoma Surveillance: A Review of Current Evidence and Guidelines. [2020]

6. Ireland pubmed.ncbi.nlm.nih.gov

Linear mixed-effects models for predicting sarcoma local recurrence growth rates: Implications for optimal surveillance imaging frequency. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Designing a Rational Follow-Up Schedule for Patients with Extremity Soft Tissue Sarcoma. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Follow-up of the soft tissue sarcoma patient. [2015]

9. Germany pubmed.ncbi.nlm.nih.gov

Local recurrence of soft-tissue sarcoma: issues in imaging surveillance strategy. [2018]