All studies
Not yet recruitingPHASE3INTERVENTIONAL

High Versus Lower Intensity Surveillance Following Resection of Retroperitoneal Sarcoma

This study, called SARveillance, is for adults who have had surgery to remove a type of cancer called soft tissue sarcoma from their tummy (abdomen) or pelvis. We want to find out whether having more frequent scans (high-intensity) or less frequent scans (lower-intensity) after surgery is better for checking if the cancer has come back. Both approaches are currently used in hospitals. By comparing them, we hope to improve how we monitor patients. The study involves hospitals from across the world and also considers what patients prefer for their follow-up scans.

At a glance

Status
Not yet recruiting
Phase
PHASE3
Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Enrolment target
584
Start
01 Nov 2024
Estimated completion
01 Dec 2033

What is this study about?

The SARveillance study is looking into the best way to follow up patients after they've had surgery for a particular type of cancer called soft tissue sarcoma. This sarcoma is located in the tummy (abdomen) or pelvis, specifically in the area behind the lining of these cavities (retroperitoneal).

When you've had surgery for this kind of cancer, doctors need to keep a close eye on you to make sure the cancer hasn't returned. This is usually done with scans. However, different hospitals and doctors have different ideas about how often these scans should happen. Some believe in more frequent scans, while others think less frequent scans are just as good, or even better, to reduce stress and hospital visits. This study aims to compare these two approaches – a 'high-intensity' schedule with more scans, and a 'lower-intensity' schedule with fewer scans – to see which one works best for patients.

The main goal is to understand if one scanning schedule is more effective at catching any cancer recurrence early, or if a less intensive schedule is just as safe and perhaps more convenient for patients. The study is carefully designed, involves many hospitals worldwide, and importantly, takes into account patients' wishes regarding their follow-up care. The results will help doctors make better, more consistent decisions about post-surgery monitoring for retroperitoneal sarcoma patients in the future.

Key takeaways

  • Compares two different scanning schedules after sarcoma surgery.
  • Aims to find the best way to monitor for cancer coming back.
  • Involves adults who have had their first sarcoma surgery in the tummy or pelvis.
  • You might be randomly assigned to a scanning schedule, or you might choose.
  • Both scanning schedules are already used in hospitals.

Who may be eligible?

This study is looking for adult patients, aged 18 or over, who have recently had their first surgery to remove a soft tissue sarcoma from their tummy or pelvis. Doctors need to have confirmed that it is indeed a soft tissue sarcoma under a microscope, and the surgery should have removed all visible cancer.

You might be suitable even if you had other treatments before your surgery. However, you can't join if the cancer had spread to other parts of your body when you were considered for the study, or if scans show there's still cancer left after your surgery. Also, if you've had multiple surgeries for recurring soft tissue sarcoma or specific types of sarcomas like those in the womb or gut, you won't be able to participate. The aim is to study new patients after their first successful removal of this specific type of sarcoma.

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.

  1. Are you an adult (18 or over)?
  2. Have you recently had your first surgery for a soft tissue sarcoma?
  3. Was your sarcoma in your tummy (abdomen) or pelvis?
  4. Are scans clear, showing no cancer spread or left behind after surgery?
Answer every question to see your result.

What does participation involve?

If you decide to take part in the SARveillance study, you might be asked if you're happy to be randomly assigned to either the 'high-intensity' or 'lower-intensity' scanning schedule. This means a computer will decide whether you have more regular scans or less regular scans. If you prefer not to be randomly assigned, you can choose which scanning schedule you'd like to follow, if your doctor agrees.

Your participation will mostly involve attending your scheduled follow-up scans, which will be either more or less frequent depending on your assigned or chosen schedule. These scans will be part of your routine medical care. The study will collect information from these scans and your medical records to see how effective each approach is. The total duration of your participation will depend on the follow-up schedule itself, which can last for several years, similar to standard long-term follow-up after cancer surgery.

Potential risks and benefits

Taking part in this study could help future patients with this type of cancer by identifying the best way to monitor them after surgery. While there are no new experimental treatments in this study, you will be receiving either a 'high-intensity' or 'lower-intensity' scanning schedule, both of which are current practices in different hospitals. The main 'risk' could be the potential anxiety associated with more frequent scans in the high-intensity group, or the possibility of a delayed diagnosis if cancer recurs in the lower-intensity group, although both schedules are considered safe. You are free to withdraw from the study at any time without affecting your medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Fondazione IRCCS Istituto Nazionale dei Tumori
    Verified postcode
    Milan, Italy
  • University Hospitals Birmingham NHS Foundation Trust
    Verified postcode
    Birmingham, United Kingdom

Common questions

What is retroperitoneal soft tissue sarcoma?

It's a rare cancer that grows in the soft tissues behind the lining of your tummy and pelvis.

Why are you doing this study?

We want to find the best scanning schedule after surgery to check for cancer recurrence, either more often or less often.

Will I get new medicine?

No, this study is about how often you have scans, not about new medicines or treatments.

Do I have to have scans very frequently if I join?

Not necessarily. You might be in a group with more frequent scans or less frequent scans, or you might be able to choose.

Can I leave the study at any time?

Yes, you can decide to stop participating at any point, and it won't affect your medical care.

How to find out more

Marco Fiore, MD

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "High Versus Lower Intensity Surveillance Following Resection…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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