RecruitingNAINTERVENTIONAL

Neoadjuvant Irradiation of Retroperitoneal Soft Tissue Sarcoma With Ions Retro-Ion

This research study is investigating new and advanced types of radiation therapy – proton and carbon ion therapy – for people with retroperitoneal soft tissue sarcoma, a type of cancer deep in the tummy area. Before surgery, patients will receive one of these radiation treatments. The main goal is to find out if these newer radiation methods are safe and practical, meaning they don't cause a lot of serious side effects or lead to treatment being stopped early. Doctors also want to see how well these treatments help control the cancer and improve quality of life. This study hopes to offer a better option for people facing this challenging cancer.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital Heidelberg

Enrolment target

Start

09 May 2019

Estimated completion

09 May 2027

Sarcoma,Soft Tissue

What is this study about?

This study is looking at a type of cancer called retroperitoneal soft tissue sarcoma. This is a rare cancer that grows in the soft tissues at the back of your tummy area. Usually, the best way to treat it is by removing the tumour with surgery. Before surgery, doctors often give radiation therapy to shrink the tumor and make the surgery more successful. This study is testing two new types of radiation – called proton therapy and carbon ion therapy.

These special types of radiation are thought to be more precise than standard radiation. This means they can target the cancer more accurately, protecting nearby healthy organs like your bowel, kidneys, and liver from damage. By doing this, doctors hope to reduce the side effects you might experience.

The main aim of this study is to check how safe these new radiation treatments are. They want to see if the treatments cause serious side effects (like those that might lead to treatment being stopped) and if they are practical to deliver. They will also be looking at how well the cancer is controlled, your overall health, how long you live without the cancer coming back, and importantly, your quality of life during and after treatment.

Key takeaways

Tests new, precise radiation for retroperitoneal soft tissue sarcoma.
Compares proton and carbon ion therapies before surgery.
Main focus is on safety and practical use of these treatments.
Aims to protect healthy organs and reduce side effects.
Also looking at how well cancer is controlled and your quality of life.
You'll be randomly assigned to one of the two treatments.

Who may be eligible?

To be considered for this study, you would need to have been diagnosed with retroperitoneal soft tissue sarcoma, and your doctors must believe it can either be removed by surgery or is nearly removable. You also need to be at least 18 years old and in reasonably good health, able to carry out most of your daily activities.

There are some reasons why you couldn't join. For example, if your cancer has already spread to other parts of your body or to your lymph nodes. You also can't have certain metal implants near the cancer area or have had radiation in that area before. Other specific conditions like Desmoid tumors or GIST, previous radiation therapy in the treatment area, or participation in another study that could affect the results would also prevent you from joining. The study is also not for pregnant women or those with certain active medical devices like pacemakers that aren't safe with this type of radiation.

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 you have retroperitoneal soft tissue sarcoma?
Do your doctors think your cancer can be removed by surgery?
Are you 18 years or older?
Are you generally well and able to do most daily activities?
Has your cancer not spread to other parts of your body (no distant spread or lymph node spread)?
Are you not pregnant and don't have certain medical implants that would be affected by radiation?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first be randomly assigned to receive either proton radiation or carbon ion radiation, much like flipping a coin. You would receive six radiation treatments per week. The total length of the radiation treatment period is not specified but is delivered in six 'fractions' (meaning individual sessions).

During and after your treatment, you would have regular check-ups to monitor your health, look for any side effects, and see how the treatment is working. Doctors will also ask you to fill out questionnaires about your quality of life. The study monitors how well the treatments work and your health over time, so you'd have follow-up appointments for a period after your main treatment. The full duration of your participation, including follow-up, would be fully explained by the study team.

Potential risks and benefits

Taking part in any medical study carries potential benefits and risks. A potential benefit of this study is that you might receive a new, more precise radiation treatment that could lead to fewer side effects compared to standard radiation, and potentially better cancer control. However, like all medical treatments, there are potential risks, including side effects from the radiation treatments, which may be serious. The study team will explain all known side effects in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

University Hospital of Heidelberg, Radiation Oncology
Verified postcode
Heidelberg, Germany· Recruiting

Common questions

What is retroperitoneal soft tissue sarcoma?

It's a rare cancer that develops in the soft tissues and muscles deep in the tummy area, behind many of your organs.

What's the difference between proton and carbon ion radiation?

They are both advanced forms of radiation that can target cancer more accurately than traditional radiation, potentially causing less harm to healthy tissues nearby.

Will I know which treatment I'm getting?

Yes, once you're randomly chosen for either proton or carbon ion therapy, the study team will let you know which one you will receive.

What does 'neoadjuvant' mean?

It means the treatment (in this case, radiation) is given before the main treatment, which is usually surgery, to help make it more effective.

Will this study cure my cancer?

This study is looking at how safe and effective these new treatments are. While it aims to improve outcomes, no study can guarantee a cure. The goal is to find better ways to treat this cancer.

How to find out more

Juergen Debus, Prof.

juergen.debus@med.uni-heidelberg.de +496221 Official trial record

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