RecruitingPHASE3INTERVENTIONAL

A Randomized Phase III Trial of Stereotactic Ablative Radiotherapy for Patients With Up to 10 Oligometastases and a Synchronous Primary Tumor.

This study is for people who have a main cancer tumor and up to 10 small cancer spots (metastases) spread to other parts of their body. Researchers are looking at a powerful type of radiation therapy called Stereotactic Ablative Radiotherapy (SABR). They want to see if adding SABR to the usual cancer treatments can help patients more than just having the usual treatments on their own. This is a "Phase III" study, which means it's one of the final steps before a treatment might become a standard option. Patients will be put into one of two groups by chance: one group will receive standard care, and the other will receive standard care plus SABR to their cancer spots.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

David Palma

Enrolment target

180

Start

06 Oct 2023

Estimated completion

01 Apr 2029

Metastatic Tumor

What is this study about?

This study is an important research project looking into how we treat certain cancers. If you have a primary (main) cancer tumor and a few small areas where the cancer has spread – doctors sometimes call these 'oligometastases', meaning 'a few' spread spots – this study might be relevant to you. The main idea is to investigate a powerful and precise type of radiation therapy called Stereotactic Ablative Radiotherapy, or SABR for short.

SABR is a very focused way to deliver high doses of radiation directly to the cancer spots, aiming to destroy them while largely sparing healthy tissues around them. Currently, people with cancers that have spread are often treated with a combination of therapies like chemotherapy, hormone therapy, immunotherapy, or targeted drugs. This study wants to see if adding SABR to these standard treatments can improve outcomes for patients compared to just having the standard treatments.

You would be randomly assigned to one of two groups. One group would receive the current best standard care for your type of cancer. The other group would receive the same standard care, but would also get SABR treatment directed at the small areas where your cancer has spread. By comparing these two groups, researchers hope to find out if SABR offers an extra benefit and could become a more common part of treatment plans for people like you.

Key takeaways

This study evaluates adding special radiation (SABR) to standard cancer treatment.
It's for people with a main tumor and a few small spread cancer spots (1-10 spots).
Patients are randomly assigned to either standard care or standard care plus SABR.
SABR is a precise, high-dose radiation aimed at specific cancer areas.
The goal is to see if SABR improves outcomes for this group of patients.
Participation involves careful monitoring and regular check-ups.

Who may be eligible?

To be able to join this study, you need to be an adult (18 years or older) and have a main cancer tumor along with 1 to 10 small areas where the cancer has spread. You should also generally be in good health, able to do most of your daily activities, and doctors expect you to live for at least six more months.

There are some conditions that would mean you can't take part. For example, if you have certain serious lung conditions and need radiation to your chest, or if you have severe liver problems and have cancer in your liver. Also, if you have certain bowel conditions and need radiation to your tummy area, or if you have specific immune system disorders, you might not be suitable. The study also cannot include you if your cancer has spread to the brain and the spots are very large, or if it would be impossible to aim the radiation at all the areas where your cancer has spread. Your doctors will check all these carefully.

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 a main cancer tumor and 1 to 10 small areas where the cancer has spread?
Are you generally feeling well enough to manage most daily activities?
Are you able to provide your agreement to participate after understanding the study?
Do you have any severe liver, lung, or bowel conditions that might prevent radiation treatment?
Are your cancer spots in the brain smaller than 3cm, or is there not a large total volume of brain cancer?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first go through a screening process to make sure you meet all the requirements. Once enrolled, you'll be assigned by chance to one of two treatment groups: one group gets standard care, and the other gets standard care plus SABR. The SABR treatment involves precise radiation sessions targeted at your cancer spots. You'll have regular hospital visits for assessments, scans, and to check how you're doing. The research team will carefully monitor you throughout the study. The total duration of your participation, including follow-up appointments, will be explained in detail by the study team.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. A potential benefit of this study is that you might receive SABR, which is a highly focused treatment, in addition to your standard care, and this *might* improve your cancer control. However, there's no guarantee it will work, and you might also experience side effects from the SABR treatment, such as fatigue, skin irritation, or other issues depending on where the radiation is aimed. Standard treatments also carry their own risks and side effects. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (5)

BC Cancer - Centre for the North
Verified postcode
Prince George, Canada· Not yet recruiting
BC Cancer - Vancouver
Verified postcode
Vancouver, Canada· Recruiting
London Regional Cancer Program of the Lawson Health Research Institute
Verified postcode
London, Canada· Recruiting
Centre Hospitalier de l'Université de Montréal-CHUM
Verified postcode
Montreal, Canada· Recruiting
Universitätsspital Zürich
Verified postcode
Zurich, Switzerland· Recruiting

Common questions

What is SABR?

SABR stands for Stereotactic Ablative Radiotherapy. It's a very advanced type of radiation that delivers high doses of radiation precisely to cancer spots, aiming to destroy them while protecting healthy tissue nearby.

What does 'randomized' mean?

Being 'randomized' means you will be put into one of the study groups by chance, like flipping a coin. This helps make sure the study results are fair and accurate.

What are 'oligometastases'?

'Oligometastases' just means a few (oligo) cancer spots that have spread (metastases) from the main tumor to other parts of the body.

Will I still get my usual cancer treatments?

Yes, both groups in this study will receive the usual, standard care treatments for their cancer. One group will just have SABR added to that standard care.

How long will the study last?

The full duration of your involvement, including follow-up check-ups, will be explained in detail by the study doctor or nurse.

How to find out more

David Palma, MD, PhD

david.palma@lhsc.on.ca 519-685-8650 Official trial record

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