RecruitingNAINTERVENTIONAL

Impact of Hypofractionated Radiotherapy Strategy After Surgery of Skin Carcinomas in Older Patients

Many older people get non-melanoma skin cancer. Usually, surgery removes these cancers. However, some types are more likely to come back. Doctors often consider extra treatment like radiation to stop this, but we don't know enough about how radiation affects older patients' day-to-day lives or which radiation method is best. This study aims to find out. We're comparing surgery alone, surgery with a standard course of radiation, and surgery with a shorter, more intense course of radiation. By collecting information on whether the cancer returns and how patients feel, we hope to improve care for older people with skin cancer.

At a glance

Status

Recruiting

Phase

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

303

Start

17 Oct 2023

Estimated completion

01 Mar 2028

Skin Cancer, Non-Melanoma

What is this study about?

This study is about finding the best way to treat common types of skin cancer in older patients, specifically those aged 70 and over. These are called non-melanoma skin cancers. While surgery is the main treatment, some cancers have features that make them more likely to come back in the same area. When this happens, doctors sometimes suggest extra treatment with radiation therapy after surgery.

However, there's not enough clear information about how this extra radiation therapy affects older patients, especially their quality of life. We also don't know which type of radiation therapy works best or is easiest for them. Some radiation treatments involve many sessions over several weeks, while others are shorter and more concentrated. This study looks at whether adding radiation after surgery helps prevent the cancer from returning, and importantly, how these different treatments affect patients' well-being and daily lives.

The main goal is to compare three approaches: surgery alone, surgery followed by moderate radiation therapy (15 sessions), and surgery followed by a very short, intense course of radiation therapy. By carefully tracking the results and gathering information from patients themselves, this research aims to give doctors clearer guidance on managing skin cancer in older individuals, ensuring they receive treatment that is both effective and supportive of their overall health and quality of life.

Key takeaways

This study focuses on older patients (aged 70+) with common skin cancers.
It compares surgery alone versus surgery plus two different radiation treatments.
The goal is to find the most effective treatment that also supports quality of life.
You'd receive close monitoring and share your experiences through questionnaires.
Participation helps improve future care for older people with skin cancer.

Who may be eligible?

To join this study, you must be at least 70 years old and have a confirmed diagnosis of certain types of non-melanoma skin cancer (either basal cell carcinoma or squamous cell carcinoma) that has been completely removed by surgery, but has features that suggest it might be at a higher risk of coming back. You should generally be in good health for your age and have a life expectancy of at least six months. You also need to be able to give your informed consent or have a legal representative do so.

There are certain reasons why you might not be able to join. For example, if your cancer wasn't completely removed in the initial surgery, or if you've already had radiation therapy to the same area. People with severe memory problems that would make it hard to follow the study's plan, or those involved in other medical trials that could affect the results of this one, also wouldn't be able 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.

Are you 70 years old or older?
Have you had basal cell or squamous cell skin cancer removed by surgery?
Does your doctor think your cancer has a higher chance of coming back?
Are you generally in good health?
Can you commit to regular hospital visits and answering questions about your health?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned to one of three groups: surgery alone, surgery followed by moderate radiation therapy (15 sessions), or surgery followed by a very brief, intense course of radiation therapy. Your participation will involve regular visits to the hospital for check-ups and assessments, where doctors will monitor your health and the area where your cancer was removed. You will also be asked to complete questionnaires about your quality of life, which means sharing how you feel about your health and daily activities.

The specific number of visits and the total duration of your involvement will depend on the treatment group you are in and how long the researchers need to follow your progress to see if the cancer returns. All treatments and follow-up care will be provided by the study team. You won't be given any new medications specifically as part of this study, but your existing medications will be reviewed. You can withdraw from the study at any time.

Potential risks and benefits

Participating in this study might offer a potential benefit by helping doctors find the best treatment for your type of skin cancer, which could reduce the chance of it returning. You would also receive close medical attention and monitoring. However, there are potential risks, such as side effects from radiation therapy, which can include skin irritation or fatigue, depending on the type of radiation you receive. There is no guarantee that the treatment you receive as part of the study will be more effective than standard care. You have the right to withdraw from the study at any time without affecting your usual medical care.

Locations (1)

Henri Mondor
Verified postcode
Créteil, France· Recruiting

Common questions

What is 'non-melanoma skin cancer'?

It's a common type of skin cancer, different from melanoma. The two main types involved in this study are basal cell carcinoma and squamous cell carcinoma.

What does 'radiation therapy' mean?

Radiation therapy uses high-energy rays to kill cancer cells or stop them from growing. It's often given after surgery to help prevent the cancer from coming back.

What's the difference between the radiation treatments?

One type involves 15 sessions over several weeks, while the other is a much shorter, more intense treatment given in fewer sessions, sometimes even just one. The study is comparing these two against no radiation after surgery.

Will I have to pay to be part of this study?

No, your participation in the study, including any treatments or assessments directly related to the research, will not incur costs to you if you are affiliated with a social security scheme.

What is 'quality of life' in this study?

Researchers will ask you how you feel about your health, daily activities, and general well-being to understand how different treatments might affect your overall life.

How to find out more

YAZID BELKACEMI, MD, PhD

yazid.belkacemi@aphp.fr 1 49 81 45 22 Official trial record

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