Active not recruitingOBSERVATIONAL

Re-irradiation of Recurrent Head and Neck Cancer

This study is investigating a new way to treat head and neck cancer that has returned in a part of the body that has already received radiation treatment. Normally, if surgery isn't possible, doctors might offer chemotherapy. However, for some patients, further radiation might be an option. This study uses a specialised type of radiation called proton therapy. Proton therapy is thought to be more precise than standard radiation, meaning it could potentially harm less healthy tissue nearby. We want to see if proton therapy is safe for these patients and how effectively it controls the cancer. We'll be closely monitoring for any side effects and how well the treatment works for at least two years.

At a glance

Status

Active not recruiting

Sponsor

Technische Universität Dresden

Enrolment target

Start

01 Jul 2015

Estimated completion

01 Dec 2026

Head-and-neck Carcinoma

What is this study about?

This study focuses on a specific challenge in treating head and neck cancer: when the cancer reappears in an area that has already been treated with radiation. Doctors usually try surgery in these situations. If surgery isn't an option, or if some cancer remains afterwards, the standard treatment might be chemotherapy to help manage the disease. However, for a small number of patients who are otherwise quite well and have smaller cancer areas, it might be possible to give more radiation.

This study is exploring a newer type of radiation therapy called proton therapy. Think of it like a very precise laser treatment for cancer. While traditional radiation can affect healthy tissues around the cancer, proton therapy can be more targeted. This means it might deliver less radiation to healthy parts of the body, potentially leading to fewer side effects.

The main goal of this study is to carefully observe patients receiving proton therapy for recurrent head and neck cancer. We want to understand how safe it is, especially looking at any potential long-term side effects that might appear over 24 months. We also want to see how well the proton therapy controls the cancer in the treated area.

Key takeaways

This study uses proton therapy for head and neck cancer that has returned in a previously treated area.
Proton therapy aims to be more precise, potentially reducing side effects.
The study will observe how safe the treatment is and how well it controls the cancer.
You'll have regular check-ups during and after treatment for at least two years.
It's for patients who are generally well and have specific cancer characteristics.

Who may be eligible?

To be considered for this study, your head or neck cancer must have returned in an area that has already been treated with a significant amount of radiation. This is a key point, as the study specifically looks at re-treatment. Your cancer size and location need to be suitable for this type of focused radiation, and doctors will make sure the cancer hasn't spread to distant parts of your body.

You also need to be at least 18 years old and in good general health (meaning you're able to carry out your daily activities without much trouble). There are also specific timeframes required between your previous radiation treatment and this current one – at least one year if it's the same cancer coming back, or at least six months if it's a new cancer that has appeared in the previously treated area.

Things that would mean you couldn't join the study include being pregnant, having cancer that has spread to distant parts of your body, or if the time between your previous radiation and now doesn't meet the study's requirements. You also can't be taking part in another clinical trial where you're receiving additional treatment at the same time.

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.

Has your head or neck cancer come back in an area that was previously treated with radiation?
Are you at least 18 years old?
Are you generally in good health and able to manage daily activities?
Has it been at least one year since your previous radiation for a recurring cancer, or six months for a new cancer in the same area?
Has your doctor confirmed your cancer has not spread to distant parts of your body?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive proton therapy five days a week, with each session delivering a small dose of radiation, similar to how standard radiation is given. During your proton therapy, you'll have weekly check-ups with the study team. After your treatment finishes, you'll have follow-up appointments every three months for the first two years to monitor your health and how well the treatment worked. This means the study will involve regular contact with the hospital for at least two years after your treatment ends. Before starting, the team will ensure you've had any necessary dental work, and your previous treatment records and scans will be reviewed.

Potential risks and benefits

Potential benefits of taking part include receiving an advanced type of radiation therapy that might offer a more targeted treatment with potentially fewer side effects compared to standard radiation, especially in areas that have been treated before. However, as with any cancer treatment, there are potential risks, including side effects from the radiation itself, which the study will carefully monitor. You will be fully informed about these risks. It's important to remember that participating in any clinical study is always voluntary, and you have the right to withdraw at any time without affecting your future medical care.

Locations (1)

Dresden University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology; and DKTK partner site Dresden
Verified postcode
Dresden, Germany

Common questions

What is proton therapy?

Proton therapy is a very precise type of radiation that uses protons (tiny particles) to target cancer cells. It's thought to be more accurate than standard radiation, potentially causing less damage to healthy tissue.

Can I still get other treatments while on this study?

No, you cannot take part in another study that involves receiving additional treatments at the same time as this proton therapy study.

What kind of side effects will you be looking for?

The study will closely monitor for any side effects both during and after treatment, especially those that might appear later on. We are particularly interested in how safe this treatment is.

How long will I be followed up after treatment?

You'll have regular follow-up appointments every three months for the first two years after your proton therapy finishes.

Will this treatment cure my cancer?

There's no guarantee that any treatment will cure cancer. This study aims to see how well proton therapy controls the cancer and how safe it is in your specific situation.