AuthorisedTherapeutic exploratory (Phase II)Interventional

Phase II study of Durvalumab (MEDI4736) plus Total Neoadjuvant Therapy (TNT) in locally advanced rectal cancer (The DUREC trial)

This study, called DUREC, is investigating a new treatment approach for people with locally advanced rectal cancer. It combines a standard chemotherapy and radiotherapy treatment, given before surgery, with a new immunotherapy drug called Durvalumab. Researchers want to see if this combined treatment can entirely get rid of the cancer before surgery, which is called a 'pathological complete response'. They will also look at how much the tumour shrinks, the safety of the treatment, and if it reduces the chances of the cancer coming back in the future. The study is for adults aged 18 and over, of any gender.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Grupo Espanol Multidisciplinar En Cancer Digestivo

Enrolment target

Start

15 Nov 2024

Locally advanced rectal cancer

What is this study about?

This study, called the DUREC trial, is for people who have locally advanced rectal cancer. This means the cancer has grown into the wall of the rectum, or into nearby tissues, but has not spread to distant parts of the body. Currently, the usual treatment for this type of cancer often involves chemotherapy and radiotherapy before surgery, sometimes followed by more chemotherapy. This study is exploring a new way to make this treatment even more effective.

The DUREC trial is bringing together standard chemotherapy drugs (Capecitabine, Calcium Folinate, Fluorouracil, Oxaliplatin) and radiotherapy, which is a common approach before surgery for rectal cancer. What's new and different about this study is the addition of a drug called Durvalumab. Durvalumab is a type of immunotherapy. This means it works by helping your body's own immune system fight the cancer more effectively. The aim is to see if combining these treatments can lead to a 'pathological complete response'. This is when tests after surgery show no remaining cancer cells, which is a very positive outcome.

Researchers want to understand if this combined treatment can get rid of the cancer completely before someone has surgery. They will also be carefully watching how much the tumour shrinks, how safe the treatment is, and if it reduces problems during surgery. In the longer term, they will check if patients remain free of cancer for at least three years after treatment. This is an important step to find better ways to treat locally advanced rectal cancer and improve patient outcomes.

Key takeaways

This study is testing a new way to treat locally advanced rectal cancer.
It combines standard treatments with a new immune-boosting drug called Durvalumab.
The main goal is to see if this combination can make the cancer completely disappear before surgery.
The study also monitors safety and long-term outcomes to improve future treatments.
It's for adults 18 and over with locally advanced rectal cancer.

Who may be eligible?

To be part of this study, you would need to meet certain conditions. It's designed for adults aged 18 or older, and it's open to both men and women. The most important thing is that you have been diagnosed with locally advanced rectal cancer, meaning the cancer is in your rectum or nearby tissues, but hasn't spread to other distant parts of your body.

There might be other specific health requirements or conditions that would mean you couldn't join the study, even if you meet the age and cancer type criteria. These are put in place to ensure the study is safe for participants and that the results are clear and meaningful.

Your doctor will discuss all the detailed requirements with you. It's important to remember that meeting the basic criteria doesn't automatically mean you'll be able to join; a full medical review will be needed.

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 locally advanced rectal cancer?
Are you able to undergo chemotherapy and radiotherapy?
Are you willing to have regular hospital visits and monitoring?
Are you prepared for long-term follow-up after initial treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the DUREC trial, you would receive a combination of treatments. This involves standard chemotherapy drugs (Capecitabine, Calcium Folinate, Fluorouracil, Oxaliplatin) and radiotherapy, along with the new drug, Durvalumab. These treatments would typically be given before your surgery.

You would have regular visits to the hospital for your treatment and to have your health checked. This would involve appointments for receiving the medication, blood tests, and scans to monitor how your cancer is responding and to check for any side effects. After your treatment and surgery, you would continue to have follow-up appointments to monitor your health and ensure the cancer has not returned. The total duration of your participation in the trial, including follow-up, would be discussed with you by the study team, but typically involves several years of monitoring after initial treatment.

Potential risks and benefits

Taking part in this study could potentially offer benefits, such as receiving a new and possibly more effective treatment combination for your rectal cancer. The aim is to achieve a 'complete response', where the cancer disappears entirely. However, like all medical treatments, there are potential risks and side effects from the chemotherapy, radiotherapy, and the new drug Durvalumab. These side effects will be carefully monitored by the study team, and you will be fully informed about them. You have the right 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
Spain

Common questions

What is 'locally advanced rectal cancer'?

This means the cancer has grown into the wall of your rectum or nearby tissues, but it hasn't spread to other parts of your body yet.

What is Durvalumab?

Durvalumab is an immunotherapy drug. It helps your body's own immune system find and fight the cancer.

What does 'pathological complete response' mean?

It means that after your treatment and surgery, doctors can't find any cancer cells left in the tissue when they examine it closely.

Is this a new treatment approach?

Yes, while some of the treatments are standard, combining them in this specific way with Durvalumab is a new approach being tested.

Will I still need surgery if I take part?

Yes, current plans still involve surgery after the combined chemotherapy, radiotherapy, and Durvalumab treatment.