AuthorisedTherapeutic use (Phase IV)Interventional

Systemic Neoadjuvant and adjuvant Control by Precision medicine in rectal cancer (SYNCOPE) – approach on high-risk group to reduce metastases

The SYNCOPE study is exploring new treatment approaches for rectal cancer, specifically focusing on patients who are at a higher risk of their cancer returning or spreading. It aims to find out if using a precise combination of medicines, Capecitabine Orion and Oxaliplatin Accord, can help prevent the cancer from coming back (recurrence) after initial treatment. This research is in its final stage (Phase IV), meaning the treatments are already approved for use, but doctors are looking for the best ways to combine them for specific patient groups. The main goal is to see how many people stay cancer-free after 3 and 5 years.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

HUS-Yhtymae

Enrolment target

100

Start

24 Sep 2024

Rectal cancer

What is this study about?

This study, called SYNCOPE, is all about finding better ways to treat rectal cancer, which is a type of bowel cancer. Doctors are particularly interested in helping people whose cancer is considered 'high-risk,' meaning there's a greater chance it might return or spread to other parts of the body. The word 'neoadjuvant' means treatment given before surgery, and 'adjuvant' means treatment given after surgery. So, this study is looking at how a specific combination of treatments given both before and after surgery might help.

The main idea is to use a tailored approach, sometimes called 'precision medicine,' to give patients the most effective treatment for their specific situation. The study is using two medicines: Capecitabine Orion and Oxaliplatin Accord. Both of these are chemotherapy drugs that are already approved for cancer treatment. This study is in 'Phase IV,' which means these medicines are already used in standard care, but doctors are now studying how to best combine them and use them in a specific way for high-risk rectal cancer patients to get the best possible outcome.

The most important question this study wants to answer is whether this specific treatment plan can help people stay cancer-free for longer. They will be looking at how many people are still free of cancer after three years, and then again after five years. By understanding this better, doctors hope to reduce the chances of the cancer spreading (metastases) and improve the long-term health of people with rectal cancer.

Key takeaways

This study aims to improve long-term outcomes for high-risk rectal cancer.
It uses a tailored approach with approved chemotherapy drugs, Capecitabine and Oxaliplatin.
Treatment is given both before and after surgery ('neoadjuvant and adjuvant').
The main goal is to reduce cancer recurrence (cancer coming back) over 3 and 5 years.
The study assesses how well this specific treatment plan works for patients.
It's about finding the best way to use existing treatments for better patient care.

Who may be eligible?

To be considered for this study, you would need to be 18 years old or older – there's no upper age limit. Doctors will assess your overall health and the specific details of your rectal cancer to see if this study is right for you. Both men and women can take part.

Since this study focuses on a 'high-risk group,' it means your cancer will have certain features that doctors identify as needing this particular approach. They will carefully review your medical history and test results to make sure you fit the specific criteria for the study.

It's important to remember that even if you meet the basic age and sex requirements, there will be other detailed medical conditions that your doctor will check. Only your specialist can confirm if this study is suitable for you.

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 been diagnosed with rectal cancer?
Has your doctor told you your cancer is considered 'high-risk'?
Are you able to take chemotherapy treatments given as tablets and infusions?
Are you comfortable with long-term follow-up (up to 5 years)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the SYNCOPE study, your participation would involve a tailored treatment plan using the medicines Capecitabine Orion and Oxaliplatin Accord. Capecitabine Orion comes as tablets you take, while Oxaliplatin Accord is given as an infusion, usually through a drip in your arm. This treatment would be given both before and after any surgery you might have for your rectal cancer.

You would have regular visits to the hospital or clinic for these treatments and for assessments. These assessments would likely include blood tests, scans, and doctor's check-ups to monitor your health and how the treatment is working. The study aims to track your health and look for cancer recurrence over several years, specifically for 3 and 5 years after your initial treatment. The total duration of your active treatment might vary, but the follow-up period is quite long to accurately assess the long-term benefits.

Potential risks and benefits

Taking part in this study could potentially offer you a new, more precise way to treat your rectal cancer, which might help prevent it from returning or spreading, especially if you are in a high-risk group. However, like all medical treatments, the medicines used (Capecitabine and Oxaliplatin) can have side effects. These can range from mild, like feeling sick or tired, to more serious ones, which your doctor will discuss with you in detail. It's important to know that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Finland

Common questions

What is rectal cancer?

Rectal cancer is a type of cancer that starts in the rectum, which is the last part of the large bowel, just before the anus.

What does 'high-risk group' mean?

A 'high-risk group' means patients whose rectal cancer has certain features that make it more likely to come back or spread, needing a more intensive or specific treatment approach.

Are the medicines experimental?

No, Capecitabine Orion and Oxaliplatin Accord are established chemotherapy drugs. This study is looking at the best way to combine and use them for specific rectal cancer patients.

What is the main goal of this study?

The main goal is to see if this specific treatment plan can increase the time people remain free of cancer (recurrence-free survival) over 3 and 5 years.

How long would I be involved in the study?

While active treatment times vary, the study will track your health for 3 to 5 years to see the long-term effects of the treatment and cancer recurrence.