Active not recruitingPHASE3INTERVENTIONAL

Chemo-radiotherapy Versus Radiotherapy in the Treatment of Salivary Glands and Nasal Tumors (IMRT or Protontherapy)

This study is looking at a type of cancer that can grow in the salivary glands (near your mouth and jaw) or in your nose or sinuses. These cancers are quite rare. Doctors are trying to find the best way to treat them. This study compares two main treatments: one group of patients will receive radiotherapy (a treatment using strong X-rays to kill cancer cells), and another group will receive radiotherapy combined with a chemotherapy drug called cisplatin. The aim is to see if adding chemotherapy improves the chances of successful treatment and helps prevent the cancer from coming back. This is a "Phase III" trial, meaning it's a larger study designed to get a clear answer about which treatment works better.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Groupe Oncologie Radiotherapie Tete et Cou

Enrolment target

342

Start

20 Jan 2017

Estimated completion

01 Mar 2030

HNSCC

What is this study about?

This research is focused on a group of cancers found in your head and neck, specifically in your salivary glands (which produce spit) or in your nasal area and sinuses. These types of cancers are not very common, and because of this, it's been difficult for doctors to definitively know the very best way to treat them. Often, the current treatments are based on what works for more common cancers.

Currently, treatment for these cancers often involves surgery, followed by radiotherapy. Radiotherapy uses high-energy rays to destroy cancer cells and is a common approach. However, sometimes these cancers can still come back. Doctors believe that adding chemotherapy – a medicine that kills fast-growing cells, like cancer cells – alongside radiotherapy might make the radiotherapy more effective. This is because some chemotherapy drugs can make cancer cells more sensitive to radiation, meaning the radiotherapy can work better.

This study, taking place in France, is designed to compare two treatment approaches head-to-head. Some patients will receive only radiotherapy, while others will get radiotherapy combined with a chemotherapy drug called cisplatin. By carefully comparing these two groups, researchers hope to understand if adding cisplatin chemotherapy significantly improves how well patients do, for example, by reducing the chance of the cancer returning. This information is crucial for guiding future treatment decisions for people with these specific types of cancer.

Key takeaways

This study compares radiotherapy alone versus radiotherapy with chemotherapy for certain head and neck cancers.
It focuses on rare cancers in the salivary glands or nasal area.
The goal is to see if adding chemotherapy (cisplatin) improves treatment success and survival.
This is a large 'Phase III' study, which means its results could change future standard treatments.
Participants are randomly assigned to one of two treatment groups.
There are specific health criteria to be eligible for the study.

Who may be eligible?

To join this study, people generally need to be 18 years or older. You would be considered if you have specific types of cancer in your salivary glands or sinuses that have either been removed but have a high risk of coming back, or if the cancer cannot be removed by surgery. The types of cancer must be certain kinds, and sadly, some others like melanoma, lymphoma, or certain squamous cell cancers are not included.

There are also some health checks to make sure you're well enough for the treatments. Your blood counts, kidney function, and liver function would need to be within a healthy range. If you are 70 or older, doctors will do an extra check to make sure the chemotherapy would be safe for you. You can't have had radiotherapy in the head and neck area before for this specific cancer, and the cancer shouldn't have spread to other parts of your body. Also, it's really important that you don't have any medical conditions or allergies that would make receiving cisplatin chemotherapy unsafe.

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 or older?
Do you have cancer of the salivary glands or sinuses (excluding melanoma, lymphoma, or certain squamous cell cancers)?
Have you not had radiotherapy in your head or neck area before for this cancer?
Is your cancer considered high-risk for coming back after surgery, or is it not suitable for surgery?
Are your general health (like blood counts, kidney, and liver function) acceptable for treatment?
Do you have no known allergies to cisplatin or medical conditions that prevent its use?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to one of two groups, like flipping a coin. You wouldn't get to choose which group you're in. One group receives radiotherapy only, and the other receives radiotherapy plus chemotherapy. The radiotherapy treatment involves receiving daily sessions, usually five times a week, for several weeks. If you're in the chemotherapy group, you would also receive the chemotherapy drug cisplatin through an IV drip on three specific days spread out during your radiotherapy treatment: on day 1, day 22, and day 43.

Throughout the study, you'll have regular hospital visits for assessments, including blood tests, imaging scans, and doctor check-ups, to monitor your health and how the treatment is working. Doctors will also carefully track any side effects you might experience. The total duration of the active treatment phase will be several weeks for the radiotherapy and chemotherapy, with ongoing follow-up appointments after that to monitor your long-term health and check if the cancer returns.

Potential risks and benefits

Taking part in this study might offer you the chance to receive a treatment that could potentially be more effective than standard care, especially if adding chemotherapy helps to reduce the chance of your cancer returning. However, all medical treatments have potential risks. Radiotherapy can cause side effects like skin irritation, mouth sores, or difficulty swallowing. Adding chemotherapy, like cisplatin, can also bring its own set of side effects, such as nausea, vomiting, kidney problems, hearing loss, or nerve tingling. It's important to weigh these potential benefits against the risks. Remember, you can choose to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

Hôpital Bégin
Verified postcode
Saint-Mandé, France

Common questions

What is radiotherapy?

Radiotherapy is a cancer treatment that uses high-energy X-rays or other types of radiation to kill cancer cells and shrink tumors.

What is chemotherapy?

Chemotherapy uses powerful medicines to kill cancer cells throughout the body. In this study, one drug called cisplatin is used.

What does 'Phase III' mean for a study?

A Phase III study is a large study that compares a new treatment or a new combination of treatments with the current best treatment to see if it's better.

Will I know which treatment I'm getting?

Yes, this is an 'open-label' study, meaning both you and your doctors will know whether you are receiving radiotherapy alone or radiotherapy with chemotherapy.

What are salivary gland and nasal tumors?

These are types of cancer that form in the glands that produce spit (salivary glands) or in the spaces within your nose and head called sinuses.