Active not recruitingPHASE2INTERVENTIONAL

Stereotactic Radiotherapy Combined With Chemotherapy or Not for Treatment of Oligometastases in HNSCC

If you have head and neck cancer that has spread to just a few places in your body, this study might be for you. Researchers want to see if a strong, focused type of X-ray treatment, called stereotactic radiotherapy, works better when given alone or with chemotherapy. The main goals are to see how many people are still doing well after one year, how their quality of life is, and if this treatment combination causes fewer side effects than usual. They are also looking at the cost-effectiveness of these approaches. This is a Phase 2 trial, meaning it's still in the earlier stages of checking the treatment's effectiveness and safety.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Groupe Oncologie Radiotherapie Tete et Cou

Enrolment target

Start

21 Sep 2015

Estimated completion

01 Jul 2026

Head and Neck Squamous Cell Carcinoma

What is this study about?

When head and neck cancer spreads, it can sometimes go to just a few new places in the body. Doctors call this 'oligometastases' or 'pauci-metastatic disease'. Usually, people with cancer that has spread are given chemotherapy, which helps treat the whole body. However, many patients have already had chemotherapy, and it doesn't always work as well the second time, leading to difficult side effects and a limited time of life. This study is exploring a different approach.

Stereotactic radiotherapy is a very precise type of radiation treatment that delivers high doses of radiation directly to the cancer cells, while trying to spare healthy tissue around it. It's often used when cancer has spread to a limited number of spots. The idea is that this focused treatment might control the cancer more effectively where it has spread, potentially reducing the need for strong whole-body treatments like chemotherapy, or making chemotherapy more effective.

This study aims to compare two groups: one group will receive stereotactic radiotherapy plus chemotherapy, and the other will receive stereotactic radiotherapy alone. Researchers want to find out if combining the two treatments or just using stereotactic radiotherapy offers a better quality of life and fewer side effects for patients after one year. They also want to see if these treatments can be good value for money.

Key takeaways

Compares two treatments for head and neck cancer that has spread a little.
Investigates stereotactic radiotherapy with or without chemotherapy.
Aims for better quality of life and fewer side effects.
For adults aged 18-77 with limited cancer spread.
Includes regular monitoring and follow-up.

Who may be eligible?

This study is looking for adults aged 18 to 77 who have been diagnosed with squamous cell carcinoma of the head and neck. Your cancer should have spread to only one to three places in your body, and these spots need to be suitable for treatment with stereotactic radiotherapy.

To join, you should be generally well enough to go about your daily life (doctors use a scale called PS 0-2 for this) and expected to live for at least six more months. There are also specific requirements about the size and location of your cancer spread, and previous treatments you may have had. For example, you shouldn't have had chemotherapy or local treatment for your cancer spread in the last six months.

The research team will also check your blood test results to make sure your body can handle the treatments. If you had cancer in another part of your body more than five years ago and it's thankfully gone, you might still be able to join. You'll need to be signed up with a health insurance plan and willing to sign a consent form.

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 aged 18 to 77?
Do you have head and neck squamous cell cancer that has spread to 1-3 places?
Are your cancer spots suitable for focused radiation treatment?
Have you not had chemotherapy or local treatment for your spread cancer in the last 6 months?
Are you generally well enough for daily activities?

Answer every question to see your result.

What does participation involve?

If you join this study, you will likely have regular hospital visits for assessments, scans (like a PET scan and potentially an MRI if your cancer is in the brain), and blood tests. You will receive either stereotactic radiotherapy alone or stereotactic radiotherapy combined with chemotherapy, depending on which group you are assigned to. The specific number of treatment sessions and follow-up visits will be detailed by the study team. You'll be regularly monitored to check how you respond to treatment and for any side effects. The total duration of the chemotherapy and radiotherapy part of the trial would vary, followed by a period of observation.

Potential risks and benefits

Taking part in this study could offer carefully monitored treatment that might lead to a better quality of life and fewer side effects compared to standard approaches for advanced head and neck cancer. However, as with any medical treatment, there are potential risks and side effects associated with chemotherapy and radiation, which the study team will explain in detail. There's no guarantee that the treatment will work for everyone. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Hôpital Nord Franche Comté
Verified postcode
Montbéliard, France

Common questions

What is 'squamous cell carcinoma of the head and neck'?

This is a common type of cancer that starts in the moist, flat cells that line the mouth, nose, throat, or voice box.

What does 'stereotactic radiotherapy' mean?

It's a very precise type of radiation therapy that delivers high doses of radiation directly to the tumour, aiming to protect healthy tissues around it.

What are 'oligometastases'?

This term means that your cancer has only spread to a few new, limited areas in your body, typically one to three spots.

Will I definitely get chemotherapy if I join?

You will be assigned to one of two groups: one will get stereotactic radiotherapy with chemotherapy, and the other will get stereotactic radiotherapy alone.

What does 'quality of life' mean in a study?

Researchers will ask you questions about how you feel day-to-day, your energy levels, if you have pain, and how well you can do your usual activities.