Active not recruitingNAINTERVENTIONAL

Pre-operative RadiothErapy for Soft Tissue SarcOmas

This study is investigating a new, quicker way to give radiation therapy (radiotherapy) for adults with soft tissue sarcoma. This cancer can grow in various parts of the body, like muscles or fat. Usually, patients get radiation over a longer period before surgery. This study, called 'Pre-operative RadiothErapy for Soft Tissue SarcOmas', is testing if a 'hypofractionated' approach – meaning fewer, but stronger, radiation doses – can shrink the tumour effectively and lead to fewer wound problems after surgery, while also speeding up the time to surgery. Researchers will check the cancer's response, side effects, and quality of life.

At a glance

Status

Active not recruiting

Phase

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Enrolment target

Start

05 Jun 2020

Estimated completion

31 Dec 2027

Soft Tissue Sarcoma Adult

What is this study about?

This study is investigating a different way to give radiation therapy to people who have a type of cancer called 'soft tissue sarcoma'. This cancer can grow in various parts of the body, such as muscles, fatty areas, or blood vessels. If you have been diagnosed with this type of cancer in your arm, leg, or trunk, you might have been told that you need radiation therapy before surgery to remove the tumour.

Usually, radiation therapy before surgery involves many small daily treatments over several weeks. However, this study is trying a new approach called 'hypofractionation'. This means you would receive fewer radiation treatments, but each treatment would be a bit stronger. The aim of doing this is to see if it can be just as effective at shrinking the tumour, but also reduce the common problems with wound healing that sometimes happen after surgery when traditional radiation is used. It also means you'll have less time between diagnosis and surgery.

This study will follow you closely to see how well the new radiation method works, what side effects you might experience, and how it affects your daily life and recovery. The goal is to find a treatment plan that is both effective and more convenient for patients, with potentially fewer complications.

Key takeaways

Tests a new, shorter radiation technique for soft tissue sarcoma.
Aims to achieve faster surgery and potentially fewer wound problems.
Involves 5 radiation sessions over about 10 days before surgery.
Careful monitoring of side effects and recovery over several years.
Only for adults with specific types of soft tissue sarcoma.

Who may be eligible?

This study is looking for adults aged 18 or over who have been diagnosed with soft tissue sarcoma in certain parts of their body, like an arm, leg (above the knee), or trunk.

To join, your tumour needs to be less than 15cm in size, and doctors must think that this new radiation treatment followed by surgery is suitable for you. You can't have had radiation therapy for this cancer before, and you must generally be well enough to take part.

You cannot join if your cancer has spread to your lymph nodes, or if you've already had surgery for this specific tumour at a local hospital that wasn't planned to remove the whole tumour. Also, if you have other serious health problems or other cancers (unless it's a non-serious skin cancer or a cancer you've been free of for at least 5 years), you might not be able to join.

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?
Do you have soft tissue sarcoma in your arm, leg (above the knee), or trunk?
Is your tumour less than 15cm (about 6 inches) in size?
Have you NOT had radiation therapy for this cancer before?
Are you generally well enough for treatment and follow-up appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first have some checks including a physical exam, blood tests, and scans (like an MRI or CT scan) to understand your tumour. You'll also fill out questionnaires about your quality of life.

The main part of the study involves receiving five sessions of radiation therapy, with one session every other day, over about one and a half weeks. After you finish radiation, you'll have surgery to remove the tumour about 4-6 weeks later.

After your surgery, you will have regular check-ups to monitor your recovery. This includes checking your wound at different times after surgery (from hospital discharge up to 6 months later) and looking for any side effects from the radiation or surgery. You'll also have scans periodically to check the tumour site and chest, and continue to fill out quality of life questionnaires for up to five years after surgery.

Potential risks and benefits

Potential benefits of taking part include receiving intense radiation therapy over a shorter period, which might lead to faster surgery and potentially fewer wound complications after your operation compared to traditional radiation. However, there are also potential risks; while the aim is to reduce side effects, any medical treatment carries risks, and larger doses per session could lead to different or more intense side effects for some individuals. You will be closely monitored for any side effects. Remember, joining a study is always your choice, and you are free to withdraw at any time without it affecting your usual medical care.

Locations (1)

McGill University Health Centre-Cedars Cancer Centre
Verified postcode
Montreal, Canada

Common questions

What is soft tissue sarcoma?

It's a type of cancer that grows in the soft, connecting tissues of the body, like muscles, fat, or blood vessels.

What does 'hypofractionation' mean?

It means getting fewer radiation treatments, but each treatment delivers a slightly stronger dose of radiation.

How long does the radiation treatment last in this study?

You'll have five radiation sessions, one every other day, for about one and a half weeks in total.

Will I still need surgery if I join this study?

Yes, this study involves radiation therapy before surgery, so surgery is still a planned part of your treatment.

What information will doctors collect from me during the study?

They'll check your health, do scans, and ask you to fill out questionnaires about your recovery and quality of life.