RecruitingOBSERVATIONAL

Prospective Registry Study on the Implementation of Simultaneous Postoperative Radiochemotherapy for Salivary Gland Carcinomas of the Head and Neck Region

This study is looking into a standard treatment for a specific type of head and neck cancer called salivary gland carcinoma. This cancer affects glands that produce saliva. For patients with more advanced cancer who have already had surgery, the study is investigating a combination treatment involving radiation therapy and chemotherapy given at the same time. Researchers want to understand two main things: how well this combined treatment works to control the cancer, and how well patients tolerate the treatment, meaning what side effects they might experience. This is a "registry study," which means it collects information on how this established treatment works in real-world settings after surgery.

At a glance

Status

Recruiting

Sponsor

University of Erlangen-Nürnberg Medical School

Enrolment target

100

Start

01 Jun 2024

Estimated completion

01 Jun 2037

Locally Advanced Salivary Gland Carcinoma

What is this study about?

This research is specifically for people who have been diagnosed with a type of cancer that starts in the salivary glands in the head and neck area. These glands produce saliva and are important for eating and digestion. Sometimes, this cancer can be quite advanced, even after surgery to remove it.

Doctors are looking at a specific treatment plan for these advanced cases, which involves giving two types of therapy together after surgery: radiation therapy and chemotherapy. Radiation therapy uses high-energy rays to kill cancer cells, while chemotherapy uses powerful medicines. The study wants to see how well this combined approach works in real-life situations and how patients generally feel while undergoing it.

This isn't a study where new, unproven treatments are being tested. Instead, it's a registry study, which means doctors are carefully observing and collecting information about a treatment approach that's already used in hospitals. They want to gather more detailed information about its effectiveness and side effects when used after surgery for this particular type of salivary gland cancer.

Key takeaways

This study is for advanced salivary gland cancer after surgery.
It evaluates combined radiation and chemotherapy.
Looks at how well the treatment works and is tolerated.
It's a registry study of an existing treatment, not an experimental one.
Participation requires you to be at least 18 years old and in good health.

Who may be eligible?

To be part of this study, you would generally need to have a specific type of salivary gland cancer that's considered "high-grade" (meaning it's more aggressive) and has been successfully removed by surgery. The cancer should be in a certain stage, indicating it's locally advanced but hasn't spread to distant parts of your body. You also need to be at least 18 years old and generally well enough to undergo the treatments.

There are also some reasons why you might not be able to join. For example, if your cancer has already spread to distant parts of your body, or if you've had certain other cancers recently. You also wouldn't be able to participate if you've already had chemotherapy or radiation for this salivary gland cancer, or if you have certain serious health problems that would make the combined treatment unsafe. Pregnancy and breastfeeding would also exclude you, and women who could become pregnant would need to use effective contraception.

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 salivary gland cancer that has been surgically removed?
Is my cancer considered 'high-grade'?
Am I at least 18 years old?
Have I had other cancers in the last 5 years (excluding certain skin cancers)?
Have I had previous chemo or radiation for this type of cancer?
Do I have serious uncontrolled health problems?

Answer every question to see your result.

What does participation involve?

This study is a registry study, meaning it observes an existing treatment rather than testing a new one. If you participate, you would undergo the standard combined treatment of radiation therapy and chemotherapy after your surgery for salivary gland cancer. The radiation therapy would involve daily treatments for several weeks, and the chemotherapy would be given in cycles, meaning specific days for treatment followed by rest periods. Doctors would regularly check your health, monitor for side effects, and assess how well the treatment is working. There would be follow-up appointments after your treatment is finished to track your recovery and the cancer's status. The overall duration would depend on the standard course of treatment and follow-up for this condition.

Potential risks and benefits

Participating in this study means you would receive an established combined treatment for your cancer, which may help to control the disease. However, like all treatments, radiation therapy and chemotherapy can have side effects, which can range from mild to severe. Your doctors will discuss these potential risks in detail, and they will closely monitor you throughout the process to manage any side effects. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Erlangen, Universitätsklinikum Strahlenklinik
Verified postcode
Erlangen, Germany· Recruiting

Common questions

What is salivary gland carcinoma?

It's a type of cancer that grows in the glands in your head and neck that produce saliva.

What does 'locally advanced' mean?

It means the cancer has grown bigger or spread to nearby lymph nodes, but it hasn't spread to distant parts of your body.

What is 'simultaneous radiochemotherapy'?

It's when you receive both radiation therapy and chemotherapy at the same time after your surgery.

Is this a new or experimental treatment?

No, this study is looking at an established treatment approach that is already used in hospitals for this type of cancer.

What does a 'registry study' involve?

It means doctors are collecting information about how a standard treatment works in real-life patients to learn more about its effectiveness and side effects.

How to find out more

Marlen Haderlein, PD Dr.

marlen.haderlein@uk-erlangen.de 0913185 Official trial record

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