Active not recruitingPHASE2INTERVENTIONAL

Radiochemotherapy +/- Durvalumab for Locally-advanced Anal Carcinoma. a Multicenter, Randomized, Phase II Trial of the German Anal Cancer Study Group

This study, called RADIANCE, is for people with advanced anal cancer. Standard treatment usually involves a combination of chemotherapy and radiation. This trial is investigating whether adding a new drug, called durvalumab, to this standard treatment can improve outcomes. Durvalumab is a type of immunotherapy that works by helping your body's immune system fight cancer. Researchers believe that for anal cancer, which is often linked to the HPV virus, combining durvalumab with chemotherapy and radiation might be more effective than standard treatment alone. The study aims to find out if this new combination leads to better results for patients.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Goethe University

Enrolment target

180

Start

07 Jan 2020

Estimated completion

31 Mar 2027

Anal Cancer Anal Carcinoma Anal Cancer Stage III Anal Cancer Stage II

What is this study about?

This research study, called RADIANCE, is looking into new ways to treat anal cancer that is a bit more advanced. Currently, the most common treatment for this type of anal cancer is a combination of chemotherapy (using drugs like mitomycin C and 5-fluorouracil) and radiation therapy. While this treatment works well for many, it doesn't work for everyone, with about 60% of patients doing well after three years.

Researchers are now exploring if adding a drug called durvalumab could make the current treatment even better. Durvalumab is an 'immunotherapy' drug. This means it helps your body's own immune system find and fight cancer cells. Anal cancer is often linked to a virus called HPV, which can make the cancer more likely to respond to this type of immune-boosting treatment. Scientists have also seen promising results with durvalumab in other studies.

The idea is that radiation and chemotherapy can change cancer cells in a way that makes them more visible to the immune system. When you add durvalumab, it helps your immune system act more effectively against these cancer cells. By combining these treatments, the hope is to give patients with advanced anal cancer a better chance of successful treatment than with the standard approach alone.

Key takeaways

This study is for advanced anal cancer.
It combines standard treatment with a new immunotherapy drug (durvalumab).
The goal is to see if this new combination improves treatment outcomes.
Participation involves regular checks and monitoring.
You can stop participating at any time.
Your health will be closely monitored for safety.

Who may be eligible?

To be considered for this study, you would need to have anal cancer that has been confirmed by a doctor. This cancer should be at a specific advanced stage (Stage IIB, IIIA, IIIB, or IIIC). Your doctor will be able to confirm your cancer type and stage through detailed scans and tests.

You must be 18 years old or older, with no upper age limit. Your general health should be good enough to take part, which doctors call a good "performance score." You'll also need to have healthy blood counts (like red and white blood cells, and platelets) and your kidney and liver function must be working well. Women who could become pregnant would need to take a pregnancy test and agree to use effective birth control during and after the study.

Your doctor will check all these details to see if this study is suitable for you. You would need to be able to understand the study and agree in writing to take part.

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.

Do I have anal cancer that has been diagnosed?
Has my doctor told me my anal cancer is at an advanced stage (IIB, IIIA, IIIB, or IIIC)?
Am I 18 years old or older?
Am I generally well enough to undergo cancer treatment?
Do I have healthy blood counts and good kidney/liver function?
If I am a woman who could become pregnant, am I able to use effective birth control?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the standard treatment for anal cancer, which includes chemotherapy and radiation therapy. In addition to this, you would also receive the study drug, durvalumab. All these treatments would be given at the hospital or clinic.

You would need to have regular visits for check-ups, blood tests, and scans to monitor your health and how you are responding to the treatment. These assessments are important to ensure your safety and to see if the treatment is working. The exact number of visits and the total duration of your participation would be explained in detail by the study team, but it will involve treatment over several weeks, followed by a period of close monitoring.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving a new combination of treatments that could be more effective than standard care for your type of anal cancer. However, there are also potential risks. Any medical treatment, including chemotherapy, radiation, and immunotherapy, can have side effects. The study team will explain all known side effects of durvalumab and the other treatments. Your health will be closely monitored throughout the study to manage any side effects. Remember, you have the right to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (25)

Univeritätsklinik für Strahlentherapie-Radioonkologie
Verified postcode
Graz, Austria
Institut für Radioonkologie und Strahlentherapie
Verified postcode
Darmstadt, Germany
Klinik und Poliklinik für Strahlentherapie und Radioonkologie
Verified postcode
Dresden, Germany
Klinik für Strahlenheilkunde, Universitätsklinikum Freiburg
Verified postcode
Freiburg im Breisgau, Germany
Klinik und Poliklinik für Strahlentherapie
City only
Essen, Germany
UKSH Campus Kiel
Verified postcode
Kiel, Germany
Universitätsklinikum Leipzig
Verified postcode
Leipzig, Germany
Universitätsklinikum Magdeburg
Verified postcode
Magdeburg, Germany
Universitätsmedizin Mainz
Verified postcode
Mainz, Germany
Uniklinikum Marburg
Verified postcode
Marburg, Germany
Kliniken Maria Hilf GmbH Mönchengladbach
Verified postcode
Mönchengladbach, Germany
LMU Klinikum der Universität München
Verified postcode
München, Germany

Common questions

What is durvalumab?

Durvalumab is a type of medicine called immunotherapy. It helps your body's own immune system fight cancer cells more effectively.

Why are they studying this new combination?

Researchers believe that combining standard treatment (chemotherapy and radiation) with durvalumab might be more effective for advanced anal cancer, especially since this cancer is often linked to the HPV virus.

What stage of anal cancer is this study for?

This study is for advanced stages of anal cancer, specifically stages IIB, IIIA, IIIB, or IIIC.

Will I still receive standard treatment if I join this study?

Yes, all participants in this study will receive the standard chemotherapy and radiation, with some also receiving the study drug durvalumab.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any time, for any reason, and it will not affect your usual medical care.