RecruitingNAINTERVENTIONAL

Salvage Brachytherapy and Hyperthermia for Recurrent H&N-tumours

This research study is investigating a new way to treat head and neck cancer that has returned in the same area after having earlier radiotherapy. It focuses on patients for whom further surgery is not an option because it's too risky or won't completely remove the cancer. The study combines two treatments: brachytherapy, which involves placing small radioactive sources directly into the tumour for a short time, and hyperthermia, which uses heat to make the cancer cells more sensitive to the brachytherapy. The main goal is to see how effective and safe this combined approach is for these select patients, hoping to improve their treatment options and outcomes.

At a glance

Status

Recruiting

Phase

Sponsor

University of Erlangen-Nürnberg Medical School

Enrolment target

Start

29 Mar 2017

Estimated completion

31 Dec 2027

Locally Recurrent Head and Neck Cancer

What is this study about?

This study is looking at a specific type of cancer that affects the head and neck area. Sometimes, even after initial treatment like radiotherapy, the cancer can return in the same general area. When this happens, it can be very challenging to treat, especially if surgery to remove the new tumour isn't possible or safe.

The researchers want to see if combining two special treatments can help. The first is called brachytherapy, which is a type of radiotherapy where a tiny radioactive source is placed very close to or inside the tumour itself. This delivers a high dose of radiation directly to the cancer while trying to protect healthy tissues nearby. The second treatment is called hyperthermia, which means heating the tumour. Heating cancer cells can make them more vulnerable and responsive to radiation.

By carefully combining these two treatments, the study aims to offer a new approach for people with head and neck cancer that has come back. It's about finding better ways to target and shrink these tumours when other options are limited, hopefully improving the chances of successful treatment and patients' overall well-being.

Key takeaways

This study is for recurrent head and neck cancer.
It combines internal radiotherapy (brachytherapy) with heat treatment (hyperthermia).
It's an option for patients who cannot have surgery.
The aim is to find effective new ways to treat the cancer.
Participation includes receiving the treatments and regular follow-ups.

Who may be eligible?

To be considered for this study, you would need to have head and neck cancer that has returned in the same local area, and this diagnosis must be confirmed by a biopsy. The tumour should be of a certain size (not too large) and in a location that allows for the special brachytherapy treatment. You must also not have cancer that has spread to other parts of your body.

Important conditions include having had radiotherapy for your cancer at least six months ago, with a dose of at least 50 Grays. Your general health should be good enough to participate, rated as an ECOG score of 0-2, which means you are mostly active and able to look after yourself. You also need to be willing to give your written consent to take part in the study.

However, some things would mean you can't join. For example, if your tumour is very large (T4), if your cancer has spread extensively to your lymph nodes, or if you are pregnant or breastfeeding. Certain pre-existing health conditions, like some genetic disorders that increase sensitivity to radiation or severe psychiatric conditions, would also exclude 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.

Do I have head and neck cancer that has come back?
Has my cancer been confirmed by a sample (biopsy)?
Have I had radiotherapy for my cancer at least 6 months ago?
Am I generally active and able to look after myself?
Am I pregnant or breastfeeding (if applicable)? (If yes, you cannot join).
Is my cancer in a location suitable for targeted radiation?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive two types of treatment: brachytherapy and hyperthermia. Brachytherapy involves placing small devices into or near your tumour for a short period to deliver radiation. Hyperthermia uses heat to warm the tumour area. You will have regular appointments to receive these treatments and to monitor your progress and health.

While the exact number of visits isn't specified here, you can expect a series of hospital visits for the treatments and follow-up checks. This will involve assessments like scans and examinations to see how the tumour is responding and to check for any side effects. The total duration of your participation, including follow-up appointments, will be explained to you by the study team.

Potential risks and benefits

Participating in this study might offer a potential benefit by providing a new treatment option for your head and neck cancer, especially if other treatments haven't worked or aren't suitable. However, like all medical treatments, there are potential risks, such as side effects from the radiation or heat treatment, which your doctors will discuss with you. You have the full right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Dept. of Radiation Therapy, University Hospital Erlangen
Verified postcode
Erlangen, Germany· Recruiting

Common questions

What is brachytherapy?

Brachytherapy is a type of radiation treatment where small radioactive sources are placed directly into or very close to the cancer for a short time.

What is hyperthermia?

Hyperthermia is a treatment that uses heat to warm up cancer cells, which can make them more sensitive to other treatments like radiation.

Why is this study important?

This study is looking for new and better ways to treat head and neck cancer that has come back, especially when surgery isn't an option.

Will I have regular check-ups during the study?

Yes, you will have regular appointments and tests to check how the treatment is working and to monitor your health.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, and it won't affect your regular medical care.

How to find out more

Vratislav Strnad, MD

vratislav.strnad@uk-erlangen.de ++49 9131 85 Official trial record

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