RecruitingNAINTERVENTIONAL

Sacral Chordoma: Surgery Versus Definitive Radiation Therapy in Primary Localized Disease

This research is looking at sacral chordoma, a rare bone cancer found at the base of the spine. Doctors want to compare two main ways of treating it: surgery or radiation therapy. The study aims to see which treatment is more effective for patients whose cancer has not spread to other parts of the body. Some patients may choose to be randomly assigned to one treatment, while others may choose their preferred option. This will help doctors understand the best approach to treat sacral chordoma, offering hope for improved care for those affected by this condition.

At a glance

Status

Recruiting

Phase

Sponsor

Italian Sarcoma Group

Enrolment target

100

Start

16 Mar 2017

Estimated completion

31 Dec 2026

Chordoma

What is this study about?

This study is about a type of cancer called sacral chordoma. This is a rare cancer that affects the bones at the very bottom of your spine, near your tailbone (sacrum). We want to understand the best way to treat it when it's only in this area and hasn't spread.

Currently, doctors use either surgery or radiation therapy to treat sacral chordoma. However, we don't have enough clear information to say definitively which treatment is better for everyone. This study aims to gather that information by carefully comparing these two treatments. It's an international effort, with various hospitals working together.

If you're considered for this study, you'll get detailed information about both treatment options – surgery (which might include some radiation) or radiation therapy alone. We'll explain what these treatments involve, how effective they might be, and any potential side effects. Some people might be asked if they're willing to be randomly assigned to one treatment group, like flipping a coin. Others can choose their preferred treatment, and their progress will still be followed closely.

Key takeaways

This study compares surgery and radiation therapy for sacral chordoma.
It aims to find the best treatment for cancer that hasn't spread.
Participation involves either random assignment or choosing your preferred treatment.
All participants receive detailed information about treatment options.
You can withdraw from the study at any time without impacting your care.

Who may be eligible?

To join this study, you would need to have been diagnosed with sacral chordoma that has been confirmed through a biopsy, and this cancer should be located from the S1 bone down to your tailbone. You also need to be at least 18 years old and in reasonably good health, able to carry out your daily activities.

Important conditions for joining include having no previous cancer treatments forsacral chordoma and the cancer must be visible on scans like MRI or CT. You also need to be well enough to have either surgery or radiation therapy, and you must be willing to give your written consent after understanding everything about the study.

You wouldn't be able to join if your cancer has spread to other parts of your body. Other reasons to exclude someone include having previously had radiation therapy to your hip area, or if you have other serious health problems, such as a severe heart condition, another active cancer (unless it's a very early skin or cervix cancer), or if you are pregnant or breastfeeding. We also need to make sure that you can realistically attend all the appointments and follow the study's plan.

Quick self-check

Have you been diagnosed with sacral chordoma that has been confirmed by a doctor?
Is your cancer only in the sacrum/tailbone area and has not spread?
Are you 18 years old or older?
Are you generally well and able to perform your usual daily activities?
Have you not had any prior treatment for sacral chordoma?

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

What does participation involve?

If you decide to take part in this study, you will receive full details about the treatment chosen for you – either surgery (possibly with radiation) or radiation therapy by itself. The specific details of your treatment will be decided by your medical team following established medical guidelines, just as if you weren't in a study. The study involves regular check-ups and scans to monitor your progress and the effectiveness of the treatment. These follow-up appointments are important to see how you are responding and will continue for a period of time after your main treatment. The total duration of your participation, including treatment and follow-up, will be explained fully by your study team.

Potential risks and benefits

Participating in this study might mean you receive a treatment that is found to be more effective for sacral chordoma, potentially leading to better outcomes or quality of life than another treatment. However, all medical treatments carry risks, including potential side effects from surgery or radiation therapy, such as pain, infection, or damage to surrounding tissues. The study aims to compare established treatments, so you would be receiving standard care. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (28)

Medical University of Graz
Graz, Austria· Recruiting
EBG GmbH MedAustron
Wiener Neustadt, Austria· Recruiting
Medical Faculty Carl Gustav Carus Faculty of Medicine, Department of Radiation Oncology,
Dresden, Germany· Not yet recruiting
University Hospital Carl Gustav Carus Dresden
Dresden, Germany· Not yet recruiting
University Hospital Essen. West German Proton Therapy Center Essen
Essen, Germany· Recruiting
Heidelberg Ion-Beam Therapy Center - HIT
Heidelberg, Germany· Not yet recruiting
National Center for Spinal Disorders
Budapest, Hungary· Not yet recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy· Recruiting
Istituto Ortopedico Rizzoli
Bologna, Italy· Recruiting
Azienda Ospedaliero-Universitaria Careggi
Florence, Italy· Not yet recruiting
Istituto Clinico Humanitas
Milan, Italy· Recruiting
I.R.C.C.S. Istituto Ortopedico Galeazzi
Milan, Italy· Active not recruiting

+16 more sites — see the official record for the full list.

Common questions

What is sacral chordoma?

It's a rare type of bone cancer that forms in the bones at the very base of your spine, near your tailbone (the sacrum).

What's the main goal of this study?

The main goal is to compare surgery and radiation therapy to see which one works best for treating sacral chordoma that hasn't spread.

Will I get to choose my treatment?

Some people might be asked to have their treatment chosen randomly, like by chance, while others can choose the treatment they prefer.

What happens if I don't want to be in the study?

You don't have to participate. You can still receive standard care for your condition outside of the study.

Is this a new or experimental treatment?

No, this study is comparing two well-established treatments (surgery and radiation therapy) that are already used for sacral chordoma.

How to find out more

Alessandro Gronchi, MD

alessandro.gronchi@istitutotumori.mi.it +390223903714 Official trial record

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