AuthorisedPhase II and Phase III (Integrated)Interventional

A phase 2 trial of capecitabine for recurrent and/or metastatic salivary duct carcinoma – CAESAR trial

The CAESAR trial is a research study investigating a treatment called capecitabine for people living with salivary duct carcinoma (a rare cancer that starts in the glands that make saliva) that has either returned after previous treatment or spread to other parts of the body. This study is in two parts (Phase II and Phase III) and is designed to find out how effective capecitabine is. Researchers will mainly check if the cancer shrinks or stops growing. They will also look at how long people live without the cancer getting worse, overall survival times, how much the treatment improves symptoms, if the cancer is kept under control, how safe the treatment is, and how it affects quality of life.

At a glance

Status

Authorised

Phase

Phase II and Phase III (Integrated)

Sponsor

Stichting Radboud universitair medisch centrum

Enrolment target

Start

10 Mar 2025

Salivary Duct Carcinoma

What is this study about?

The CAESAR trial is a research study for people with a specific type of cancer called salivary duct carcinoma. This is a rare cancer that affects the glands in your mouth that produce saliva. The trial is for people whose cancer has either come back after treatment or has spread to other parts of the body. The main aim of this study is to see how well a drug called capecitabine works in treating this type of cancer. Capecitabine is a chemotherapy drug, which means it's designed to kill cancer cells or slow their growth.

This study is looking at several important things. The main thing they want to find out is the "Best Overall Response Rate." This means they will be checking to see if the cancer shrinks or stops growing in response to the treatment. Besides this, the researchers will also be keeping an eye on other key areas such as how long people live without the cancer getting worse (known as progression-free survival), how long people live overall, how much the treatment helps with symptoms (clinical benefit), and how safely the body tolerates the drug. They will also look at how the treatment impacts people's daily lives and their overall well-being.

Taking part in a clinical trial like CAESAR helps researchers learn more about new treatments. This knowledge can then be used to help future patients with salivary duct carcinoma. It's an important step in finding better ways to manage and treat this condition.

Key takeaways

The CAESAR trial is testing capecitabine for recurrent or metastatic salivary duct carcinoma.
It aims to see if the drug can shrink or control the cancer.
The study also looks at how the drug affects quality of life and safety.
Participation involves taking tablets and having regular hospital visits for check-ups.
Being part of a trial helps advance medical knowledge for future patients.

Who may be eligible?

To join the CAESAR trial, you need to be an adult, 18 years old or older. There isn't an upper age limit, meaning older adults are welcome to participate if they meet the other study requirements.

The study is open to both men and women.

Beyond age and sex, there will be other specific medical conditions and test results that you would need to meet to be considered for the trial. These usually involve having a confirmed diagnosis of salivary duct carcinoma that has either returned or spread, and your general health would need to be well enough to safely receive the treatment.

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 salivary duct carcinoma?
Has your cancer come back or spread?
Are you able to take oral medication (tablets)?
Are you generally well enough to start a new treatment?

Answer every question to see your result.

What does participation involve?

If you join the CAESAR trial, you'll be given the study drug, capecitabine. This is usually taken as tablets. You would have regular visits to the hospital or clinic for check-ups, blood tests, scans, and to discuss how you are feeling. These tests are to monitor how the treatment is working and to keep an eye on any side effects. The total length of time you would be on the study can vary, depending on how you respond to the treatment and your health. Even after stopping the drug, there would likely be follow-up appointments to see how you are doing in the longer term.

Potential risks and benefits

Taking part in a trial might offer the chance to try a new treatment that isn't widely available yet, which could potentially help your condition. However, like all medications, capecitabine can have side effects, and it might not work for everyone. These side effects can range from mild to more serious, and the study team will monitor you closely and explain all the known risks. It's very important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your 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
Netherlands

Common questions

What is salivary duct carcinoma?

It's a rare type of cancer that starts in the glands in your mouth that make saliva.

What is capecitabine?

It's a chemotherapy drug, often given as tablets, designed to slow down or stop cancer cells from growing.

What does 'recurrent and/or metastatic' mean?

It means the cancer has either come back after previous treatment (recurrent) or has spread to other parts of the body (metastatic).

Will I definitely get the study drug?

Yes, if you join this trial, you will be given capecitabine. This isn't a trial where some people get a placebo (dummy treatment).

How long will the trial last for me?

The length of your participation will depend on how you respond to the treatment and your health, but there will be regular monitoring and follow-up.