RecruitingPHASE3INTERVENTIONAL

PROton Versus Photon Therapy for Esophageal Cancer - a Trimodality Strategy

This study, called PROTECT, is testing a new way to treat oesophageal cancer with radiotherapy. Standard radiotherapy uses 'photons,' but this study is looking at 'proton therapy.' Scientists believe proton therapy might be better because it can target the cancer more precisely, potentially reducing damage to healthy tissues like the lungs. The main goal is to find out if proton therapy leads to fewer lung-related side effects compared to standard treatment. Patients will be randomly chosen to receive either the standard photon therapy or the newer proton therapy, along with chemotherapy, before surgery. This research will help doctors understand the best and safest ways to treat oesophageal cancer in the future.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

University of Aarhus

Enrolment target

396

Start

01 May 2022

Estimated completion

01 Dec 2032

Esophageal Cancer Radiotherapy Side Effect Proton Therapy

What is this study about?

When someone has oesophageal cancer, doctors often recommend a treatment plan that includes radiotherapy and chemotherapy before surgery. Radiotherapy uses high-energy beams to kill cancer cells. There are two main types of radiotherapy: 'photon therapy,' which is the standard treatment, and 'proton therapy,' which is a newer, more advanced method.

This study, called PROTECT, wants to compare these two types of radiotherapy. The idea behind proton therapy is that it can deliver radiation more accurately to the tumour, potentially sparing nearby healthy organs, like the lungs and heart, from unnecessary radiation. The researchers particularly want to see if proton therapy can reduce lung complications, which can sometimes happen with radiotherapy for oesophageal cancer.

The study aims to involve many patients from different hospitals to get a clear picture. Participants will be randomly assigned to receive either the standard photon therapy or the proton therapy, in addition to the same chemotherapy drugs. This will help doctors understand if proton therapy is not only effective at treating the cancer but also safer by reducing common side effects, especially those affecting the lungs.

Key takeaways

Compares standard radiotherapy (photon) with a newer type (proton) for oesophageal cancer.
Aims to see if proton therapy reduces lung problems as a side effect.
Patients receive either photon or proton therapy plus the same chemotherapy.
Your treatment group will be decided randomly, like flipping a coin.
The study involves radiotherapy, chemotherapy, and then surgery.
Participation could help improve future treatments for oesophageal cancer.

Who may be eligible?

To be part of this study, you would generally need to have cancer in your oesophagus or where your oesophagus meets your stomach. Doctors would have confirmed this with tests, and the cancer should be at a certain stage (not spread far). You also need to be at least 18 years old and generally well enough for treatment and surgery.

Your general health would be checked through blood tests, and doctors would need to agree that surgery followed by radiotherapy and chemotherapy is a suitable plan for you. The type of surgery you're expected to have also matters.

There are also reasons why you might not be able to join. For example, if you've already had radiotherapy or certain types of surgery for cancer in your chest or stomach area, you wouldn't be eligible. Also, women who could become pregnant would need to take precautions to avoid pregnancy during the study.

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.

Do I have oesophageal cancer or cancer where the oesophagus joins the stomach?
Am I at least 18 years old?
Am I generally well enough for cancer treatment and surgery?
Have doctors confirmed that surgery and pre-surgery treatments are suitable for me?
Have I had prior radiotherapy or surgery in the chest/stomach area for cancer (excluding very minor procedures)?
If I am a woman who could become pregnant, am I willing to use effective contraception?

Answer every question to see your result.

What does participation involve?

If you join the PROTECT study, you'll be randomly assigned to one of two groups: either receiving standard photon radiotherapy or proton radiotherapy. Both groups will also receive the same chemotherapy drug treatments. You and your doctors will know which treatment you are receiving.

The radiotherapy will be given five days a week over several weeks, with the exact number of treatments being decided by your specific treatment centre. You'll have regular hospital visits for your chemotherapy and radiotherapy sessions. After completing these treatments, you will have surgery. Following treatment, you will be followed up by your medical team to see how you are doing.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving state-of-the-art proton therapy which could lead to fewer side effects, especially lung problems, although this is what the study aims to find out. As with any medical treatment, there are potential risks, including side effects from the radiotherapy and chemotherapy, which your medical team will discuss in detail. You are always free to withdraw from the study at any time, for any reason, without it affecting your standard medical care.

Locations (15)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Catholic University of Leuven
Verified postcode
Leuven, Belgium· Recruiting
Aarhus University Hospital (AUH)
Verified postcode
Aarhus, Denmark· Recruiting
Centre Léon Bérard (CLB)
Verified postcode
Lyon, France· Not yet recruiting
Centre Antoine Lacassagne (CAL)
Verified postcode
Nice, France· Not yet recruiting
Institut Curie
Verified postcode
Paris, France· Not yet recruiting
Technische Universität Dresden (TUD)
Verified postcode
Dresden, Germany· Recruiting
San Raffaele Hospital
Verified postcode
Milan, Italy· Recruiting
Centro Nazionale di Adroterapia Oncologica (CNAO)
Verified postcode
Pavia, Italy· Recruiting
Azienda Provinciale Per I Servizi Sanitari (APSS)
Verified postcode
Trento, Italy· Recruiting
Academisch Ziekenhuis Groningen (UMCG)
Verified postcode
Groningen, Netherlands· Withdrawn
Stichting Maastricht Radiation Oncology (MAASTRO)
Verified postcode
Maastricht, Netherlands· Withdrawn
Paul Scherrer Institute (PSI)
Verified postcode
Villigen, Switzerland· Recruiting

Common questions

What is the difference between photon and proton therapy?

Photon therapy uses X-rays that can travel through the body. Proton therapy uses 'protons' that can be controlled to stop after they hit the cancer, potentially causing less damage to healthy tissue beyond the tumour.

Will I know which treatment I'm getting?

Yes, both you and your medical team will know whether you are receiving photon or proton therapy.

What kind of chemotherapy will I receive?

All participants will receive the same chemotherapy drug combination, which is carboplatin and paclitaxel, given weekly for five cycles.

What happens after the radiotherapy and chemotherapy?

After completing your radiotherapy and chemotherapy, you will have surgery to remove the cancer, as planned by your medical team.

Can I leave the study once I've joined?

Yes, you can choose to leave the study at any point. Your decision will not affect your standard medical care.

How to find out more

Dorte Winter

dorte.skriver.winther@auh.rm.dk +45 78456442 Official trial record

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