RecruitingPHASE3INTERVENTIONAL

The Sagittarius Trial

The Sagittarius Trial is a study for people with colon cancer, either stage II (high-risk) or stage III, after they've had surgery. The main goal is to see if using a special blood test called a 'liquid biopsy' and looking at the cancer's genes can help doctors choose more effective and personalised treatments. This could lead to the cancer being less likely to return and improve quality of life compared to standard treatments. Participants will be placed into different treatment groups based on their test results. The study will compare standard chemotherapy with more targeted or immune-boosting treatments, carefully checking for side effects and how well people feel overall. It aims to find better ways to prevent colon cancer recurrence.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

IFOM ETS - The AIRC Institute of Molecular Oncology

Enrolment target

700

Start

22 Oct 2024

Estimated completion

01 Sep 2028

Colon Cancer Stage II Colon Cancer Stage III

What is this study about?

Colon cancer is a serious illness, and sometimes, even after surgery, tiny cancer cells can remain and cause the cancer to come back. This study, called The Sagittarius Trial, is looking for better ways to prevent this. It focuses on people who have had surgery for stage II (high-risk) or stage III colon cancer.

The trial uses a new type of test called a 'liquid biopsy', which is a blood test that can find small pieces of cancer DNA in your body. This test, along with looking at the specific genetic make-up of your cancer, helps doctors understand your cancer better. The idea is that this information can guide them in choosing the most effective and personalized treatment for you, rather than a 'one-size-fits-all' approach. This could mean less intense treatment for some, and more targeted treatment for others who need it.

The main aim is to see if this personalized approach can stop the cancer from coming back for longer, improve your quality of life, and potentially reduce unpleasant side effects compared to current standard treatments. The study will also carefully track how well these new methods work, how safe they are, and how they affect your daily life.

Key takeaways

This study aims to find better, more personalised treatments for colon cancer after surgery.
It uses a blood test called a 'liquid biopsy' to help guide treatment decisions.
The goal is to stop the cancer from coming back and improve quality of life.
You might receive standard chemotherapy or newer, more targeted treatments.
Participation involves regular hospital visits, blood tests, and health questionnaires.

Who may be eligible?

To join this study, you need to be at least 18 years old and have been diagnosed with stage II (high-risk) or stage III colon cancer that was removed with surgery. Doctors also need to be able to get a sample of your cancer tissue for testing. Your general health should be good enough to take part in the study treatments.

There are certain reasons why you might not be able to join. For example, if you've had certain other cancers recently, or if your cancer has already spread to other parts of your body. You also wouldn't be able to join if you're already taking part in another experimental study, or if you have certain serious heart conditions, bowel problems, or some infectious diseases like HIV or active hepatitis.

Additionally, if you've already had chemotherapy or similar treatments before your surgery for this specific cancer, you wouldn't be eligible. The study team will review all your medical information carefully to see if you're a good fit.

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 stage II (high-risk) or stage III colon cancer?
Does your doctor have a sample of your cancer tissue for testing?
Do you have any serious health problems like major heart disease or autoimmune illnesses that might prevent you from joining?
Have you already received chemotherapy or similar treatments before your surgery for this cancer?

Answer every question to see your result.

What does participation involve?

If you decide to take part in The Sagittarius Trial, you'll first have some special tests, including the liquid biopsy, to understand your cancer better. Based on these results, you'll be randomly assigned to one of two main treatment paths: either a standard chemotherapy plan or a more personalized plan tailored to your cancer's unique features.

For those needing treatment, you might receive standard chemotherapy (like CAPOX or FOLFOX) or a personalised treatment which could involve different chemotherapy drugs, specific immune-boosting medicines (like nivolumab and ipilimumab), or 'targeted therapies' that attack specific parts of cancer cells (like trastuzumab, pertuzumab, or panitumumab). These treatments might involve receiving medication through a drip or taking oral tablets.

Throughout the study, you'll have regular hospital visits for check-ups, blood tests (including more liquid biopsies to see how you're responding), and to discuss any side effects you might be having. You'll also be asked to fill out questionnaires about your quality of life. The study plans to last for 5 years, with follow-up appointments to track your health and monitor for any return of the cancer. You can choose to stop participating at any time.

Potential risks and benefits

Taking part in The Sagittarius Trial could offer several potential benefits. You might receive a treatment that is better matched to your specific cancer, which could make it more effective at preventing recurrence and potentially reduce side effects compared to standard treatments. You'll also be closely monitored by a medical team, and your participation will help doctors learn more about colon cancer, which could benefit future patients. However, there's no guarantee that the new treatments will work better for you than standard care. As with any medical treatment, there are potential risks. You might experience side effects from the chemotherapy, immunotherapy, or targeted therapies, which can vary widely from person to person. The study will carefully monitor these. There's also the inconvenience of extra hospital visits and tests. It's very important to remember that participating is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (26)

Charité - Universitätsmedizin Berlin
Verified postcode
Berlin, Germany· Recruiting
Azienda Sanitaria Locale di Biella
Verified postcode
Biella, Italy· Recruiting
Fondazione Poliambulanza
Verified postcode
Brescia, Italy· Recruiting
Azienda Ospedaliera Universitaria San Martino
Verified postcode
Genova, Italy· Recruiting
Istituto Europeo di Oncologia
Verified postcode
Milan, Italy· Recruiting
Istituto Clinico Humanitas
Verified postcode
Rozzano, Italy· Recruiting
Ospedale Niguarda
Verified postcode
Milan, Italy· Recruiting
Ospedale Maggiore di Novara
Verified postcode
Novara, Italy· Recruiting
Azienda Ospedaliera Universitaria di Parma
Verified postcode
Parma, Italy· Recruiting
Ospedale Santa Maria della Misericordia
Verified postcode
Perugia, Italy· Recruiting
Azienda Unità Sanitaria Locale della Romagna
Verified postcode
Ravenna, Italy· Recruiting
Policlinico Universitario Gemelli
Verified postcode
Roma, Italy· Recruiting

Common questions

What is a 'liquid biopsy'?

A liquid biopsy is a special blood test that can find tiny pieces of cancer DNA that have been released into your bloodstream, helping doctors understand your cancer without needing another tissue sample.

Will I definitely get personalised treatment?

Not everyone will. After your initial tests, you'll be randomly placed into either a standard treatment group or a personalised treatment group, which is common in research studies to fairly compare different approaches.

How long will the study last for me?

The study itself will run for 5 years. Your individual involvement will include treatment periods and follow-up checks during that time to monitor your health.

Where is this study taking place?

This study is being conducted in hospitals across Italy, Spain, and Germany. Your doctor will be able to tell you if a local hospital is participating.

What if I have side effects?

The study team will closely monitor you for any side effects from the treatments. You should always tell your medical team about any new or worsening symptoms you experience.

How to find out more

Silvia Marsoni

sagittarius@ifom.eu +39 02.574303862 Official trial record

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