Active not recruitingNAINTERVENTIONAL

Study Assessing The "Best of" Radiotherapy vs the "Best of" Surgery in Patients With Oropharyngeal Carcinoma

This study is looking at the best way to treat certain early throat cancers, specifically oropharyngeal, supraglottic, and hypopharyngeal cancers. Doctors know that both surgery through the mouth and a specific type of radiation therapy (called IMRT) can effectively treat these cancers. However, they want to find out which treatment leads to better swallowing function in patients after a year. Some new surgical techniques use very small cuts through the mouth (like laser or robotic surgery), and IMRT is a more advanced type of radiation that focuses precisely on the cancer. This research will help understand which method helps patients maintain their normal swallowing for longer.

At a glance

Status

Active not recruiting

Phase

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Enrolment target

112

Start

27 Nov 2017

Estimated completion

30 Jun 2029

Oropharyngeal Cancer Supraglottic Squamous Cell Carcinoma Hypopharyngeal Squamous Cell Carcinoma

What is this study about?

This research study is focused on people who have certain types of early-stage throat cancer. These cancers can be found in different parts of the throat, like the tonsils, base of the tongue, or the voice box area (oropharyngeal, supraglottic, and hypopharyngeal cancers).

Currently, the main ways to treat these cancers are surgery or radiation therapy. Both treatments are very good at getting rid of the cancer, but they can affect people in different ways, especially when it comes to everyday activities like swallowing. Over the last few years, surgery has become less invasive, often using special tools to operate through the mouth. Likewise, radiation therapy has become more precise, like a technique called IMRT, which aims to reduce side effects.

The main goal of this study is to compare these modern treatments. Specifically, it wants to find out if surgery through the mouth (Trans Oral Surgery) or this advanced radiation therapy (IMRT) is better at helping patients keep their normal swallowing ability for the first year after treatment. This is really important because keeping the ability to swallow well can greatly improve a person's quality of life.

Key takeaways

Compares two advanced treatments for early throat cancer: special surgery through the mouth (TOS) and precise radiation (IMRT).
Focuses on which treatment helps patients maintain their swallowing best over the first year.
Participation involves being randomly assigned to either TOS or IMRT.
Both treatments are effective for early cancer, but they have different side effects.
Being part of the study could help improve treatment for future patients.

Who may be eligible?

To join this study, you need to have been diagnosed with an early-stage cancer in certain parts of your throat, such as your tonsils, base of your tongue, or your voice box area. Your doctor will use special scans like CT or MRI to confirm where the cancer is and how advanced it is. A team of experts will check your case to make sure either surgery through the mouth or radiation therapy would be suitable for you.

You must be at least 18 years old, and for certain voice box cancers, you need to be between 18 and 70. Also, your general health should be good enough to take part in the study, which doctors check using a simple health score. We also need to be able to test your cancer tissue for certain markers, like HPV.

There are also some health checks, like blood tests, to make sure your body is working well enough to undergo treatment. If you are a woman who could become pregnant, you would need to use effective birth control during the study. Before joining, your doctors will explain everything in detail, and you'll need to give your permission by signing a form.

Quick self-check

Do you have early-stage oropharyngeal, supraglottic, or hypopharyngeal cancer?
Are you at least 18 years old (and 18-70 for certain supraglottic cancers)?
Has a team of specialists agreed that both surgery through the mouth and radiation are suitable options for you?
Are you generally well enough to undergo either treatment?
Are you able to provide consent and understand the study information?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to join this study, you will be randomly assigned to receive one of two main treatments: either surgery through the mouth (Trans Oral Surgery, or TOS) or a specific type of radiation therapy (IMRT). This is like flipping a coin, so it's fair for everyone.

If you get TOS, the surgeon will remove the cancer using special instruments through your mouth. If any cancer cells are found at the edges of the removed tissue, you might need a second small operation or follow-up radiation/chemotherapy a few weeks later. If you get IMRT, you'll have daily radiation sessions for about 6 weeks, usually five days a week. The radiation will be carefully aimed at the cancer and nearby areas where cancer might spread.

Throughout the first year after your treatment, the study will focus on how well you can swallow. You'll be asked to complete questionnaires about your swallowing function, and the medical team will monitor you closely. The total duration of active follow-up for the main part of this study, focusing on swallowing, will be one year.

Potential risks and benefits

Participating in this study might offer the benefit of receiving one of the most advanced treatments for your early-stage throat cancer, carefully monitored by a team of experts. There's also the chance to help doctors understand which treatment works best for preserving swallowing, which could improve care for future patients. However, both surgery and radiation carry their own risks and potential side effects, which your medical team will explain in detail. You might experience pain, changes in taste, difficulty swallowing, or fatigue, depending on your treatment. Remember, joining this study is completely voluntary, and you are free to withdraw at any time without affecting your normal medical care.

Locations (32)

CHU-UCL Namur - CHU Mont Godinne
Namur, Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Institut Jules Bordet-Hopital Universitaire ULB
Brussels, Belgium
U.Z. Leuven - Campus Gasthuisberg
Leuven, Belgium
Hopitaux Universitaires de Strasbourg - Hautepierre
Strasbourg, France
Universitaetsklinikum Koeln
Cologne, Germany
Universitaetklinikum Halle - Martin Luther Universitaet
Halle, Germany
Universitaets Krankenhaus Eppendorf - UKE - University Cancer Center
Hamburg, Germany
Universitaetsklinikum Jena
Jena, Germany
Staedtisches Klinikum Leipzig - Klinikum St Georg
Leipzig, Germany
Universitaetsklinikum Leipzig
Leipzig, Germany
Klinikum Rechts der isar Der Technische Universitaet Muenchen
München, Germany

+20 more sites — see the official record for the full list.

Common questions

What is 'early stage' throat cancer?

Early stage means the cancer is small and hasn't spread widely in your body, making it potentially easier to treat successfully.

What is IMRT?

IMRT stands for Intensity-Modulated Radiation Therapy. It's an advanced type of radiation that shapes the radiation beams to precisely match the tumor, helping to protect healthy tissues nearby.

What is Trans Oral Surgery (TOS)?

TOS means surgery performed through your mouth using special instruments, sometimes robots or lasers, to remove the cancer without making large cuts on your neck.

Why is swallowing so important in this study?

Swallowing is crucial for eating and drinking, and cancer treatments in the throat can sometimes make it difficult. This study wants to find the treatment that helps people keep their ability to swallow best.

What happens if I decide to withdraw from the study?

You can withdraw from the study at any time for any reason, and your decision will not affect the quality of care you receive.