Active not recruitingNAINTERVENTIONAL

Surveillance AFter Extremity Tumor surgerY

This study, called SAFETY, aims to find the best way to watch for cancer returning after surgery for a soft tissue sarcoma in an arm or leg. After this type of surgery, there's a risk the cancer could come back, especially in the lungs. Doctors want to know if checking more often (every 3 months) or less often (every 6 months), and using different scans (X-rays vs. CT scans), makes a difference to how long people live. Currently, there's no clear best way to do this, and doctors often do what they were taught. This study hopes to provide clear answers to help future patients.

At a glance

Status

Active not recruiting

Phase

Sponsor

McMaster University

Enrolment target

310

Start

19 Nov 2019

Estimated completion

01 Dec 2027

Soft Tissue Sarcoma Lung Metastases

What is this study about?

After you've had an operation for a soft tissue sarcoma in your arm or leg, there's a chance the cancer could come back. This is called a recurrence. The most common place for it to return is in the lungs. Because of this, it's really important to have regular check-ups after your surgery to look for any signs that the cancer might have come back. However, doctors aren't entirely sure what the very best way to do these check-ups is. For example, how often should scans be done? And which type of scan is best?

This study, called SAFETY (Surveillance AFter Extremity Tumor surgerY), wants to find answers to these important questions. It compares two things: how often you have your check-ups (every 3 months versus every 6 months) and what type of scans you have (standard chest X-rays versus more detailed CT scans of the chest). The main goal is to see if one way of checking makes people live longer or has other benefits.

There hasn't been much research on this before, and doctors often base their follow-up plans on their training rather than strong evidence. This study is a big, international effort involving many doctors and patients from all over the world. The aim is to gather strong evidence so that clear guidelines can be made for how best to follow up with patients after sarcoma surgery, which could improve care for many people in the future.

Key takeaways

The study helps find the best way to check for cancer returning after sarcoma surgery.
It compares different scan types (X-rays vs. CT scans) and how often they're done (every 3 or 6 months).
Results will help doctors create better follow-up plans for future patients.
Participation involves routine scans, no new drugs.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old and have had a specific type of soft tissue sarcoma in an arm or leg. You must have had surgery to remove the tumour completely, and any other treatments like radiotherapy or chemotherapy must be finished. Your tumour also needed to be a certain size.

You wouldn't be able to join if your cancer had already spread to other parts of your body when you were first diagnosed. Also, if you've recently had surgery for the cancer coming back in the same area, or if you have certain rare types of sarcoma or genetic conditions, you wouldn't be eligible. The study also can't include people who are already in other studies that conflict with this one, or who have other health issues that mean they might not live for at least another year.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you had surgery for a soft tissue sarcoma in an arm or leg?
Has your primary tumour been completely removed by surgery?
Have you finished any other treatments like radiotherapy or chemotherapy?
Did your cancer not show signs of spreading when you were first diagnosed?

Answer every question to see your result.

What does participation involve?

If you join the SAFETY trial, you'll be assigned to one of four check-up plans by chance. This means you might have chest X-rays every 3 months, chest X-rays every 6 months, CT scans every 3 months, or CT scans every 6 months. You'll continue with these check-ups for a certain period after your surgery. The type and frequency of scans are the main differences in what taking part involves. There are no new medications to take as part of this study. The total duration of your involvement will depend on your assigned follow-up schedule and how long the researchers need to collect information.

Potential risks and benefits

Taking part in this study could help doctors understand the best way to monitor patients after sarcoma surgery, potentially leading to better care for future patients. However, there are no direct health benefits guaranteed from participating, and it's possible that earlier or later detection of recurrence might not change long-term survival. There are no major risks beyond those associated with routine medical monitoring for cancer, such as radiation exposure from scans. You can choose to leave the study at any time without affecting your medical care.

Locations (35)

University of California Davis Medical Center
Verified postcode
Sacramento, United States
Hartford HealthCare
Verified postcode
Hartford, United States
University of Florida Health Shands Hospital
Verified postcode
Gainesville, United States
UChicago Medicine
Verified postcode
Chicago, United States
Parkview Cancer Institute
Verified postcode
Fort Wayne, United States
Holden Comprehensive Cancer Center
Verified postcode
Iowa City, United States
Dartmouth-Hitchcock Medical Center
Verified postcode
Lebanon, United States
Albany Medical Center
Verified postcode
Albany, United States
NYU Langone Orthopaedic Hospital/Perlmutter Cancer Center
Verified postcode
New York, United States
Montefiore Medical Center
Verified postcode
The Bronx, United States
Cleveland Clinic
Verified postcode
Cleveland, United States
Oregon Health and Science University Hospital
Verified postcode
Portland, United States

Common questions

What is a soft tissue sarcoma?

It's a rare type of cancer that grows in the body's soft tissues, like muscle, fat, or nerves. This study focuses on those found in arms or legs.

Why is this study looking at different types of scans?

Doctors want to know if more detailed scans (CTs) or less detailed ones (X-rays) are better at finding cancer recurrence, and if one makes a difference to how you do in the long run.

What does a 'recurrence' mean?

It means the cancer has come back after treatment. For soft tissue sarcoma, it often returns in the lungs.

Will I get to choose my check-up plan?

No, you'll be assigned to a plan (either every 3 or 6 months, and X-ray or CT scan) by chance, like flipping a coin. This helps make the study fair.

What happens if they find something on a scan?

If a scan shows something concerning, your usual medical team will follow up as they normally would outside of the study to investigate further and decide on the next steps.