AuthorisedPhase I and Phase II (Integrated)- OtherInterventional

Phase I-II prospective trial, multicenter, open label, exploring the combination of Trabectedin plus RAdiotherapy in Soft Tissue Sarcoma patients

This research is testing a new way to treat soft tissue sarcoma, a type of cancer that affects muscles, fat, and other body tissues. The study combines a chemotherapy drug called Yondelis (also known as trabectedin) with radiotherapy. Doctors want to find the best dose of Yondelis to use alongside radiotherapy, which means finding a dose that works well without causing too many side effects. They will also be carefully watching how well this combination treatment shrinks tumours. For some patients, the study hopes to significantly reduce the chances of the cancer returning after treatment. This is an early-stage study, meaning it's one of the first times this combination is being tested in people.

At a glance

Status

Authorised

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Asoc Grupo Espanol De Investigacion En Sarcomas

Enrolment target

163

Start

25 Nov 2024

Soft tissue sarcoma patients

What is this study about?

This study is looking at a new treatment approach for patients with soft tissue sarcoma. Soft tissue sarcoma is a cancer that can grow in various parts of the body, such as muscles, fat, nerves, and blood vessels. Treatments often involve surgery, radiotherapy, and sometimes chemotherapy.

Researchers are investigating whether combining a chemotherapy drug called Yondelis (also known by its scientific name, trabectedin) with radiotherapy could be a more effective way to treat this cancer. Yondelis works by stopping cancer cells from growing and multiplying. Radiotherapy uses high-energy rays to kill cancer cells and shrink tumours. The idea is that using these two treatments together might boost their ability to fight the cancer.

The main goal of this research is to safely find the best dose of Yondelis to give alongside radiotherapy. They will start with a small dose and gradually increase it, carefully checking for any side effects to find the highest dose that is safe and well-tolerated. They also want to see how well this combined treatment shrinks the cancer and, for some patients, if it can help stop the cancer from coming back after treatment, hopefully improving their long-term health.

Key takeaways

This study is for adults with soft tissue sarcoma.
It combines chemotherapy (Yondelis) with radiotherapy.
The main aims are to find a safe dose and see how well it works.
The study hopes to reduce the chance of cancer returning for some patients.
It's an important step in finding new cancer treatments.

Who may be eligible?

This study is looking for adult patients who have been diagnosed with soft tissue sarcoma. To be eligible, you need to be at least 18 years old, and there is no upper age limit, meaning older adults can also take part.

Both men and women are welcome to participate in this study. The medical team will check other specific health details to make sure the treatment is suitable for you and that taking part would be safe.

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 18 years old or older?
Have you been diagnosed with soft tissue sarcoma?
Are you comfortable with receiving chemotherapy and radiotherapy?
Are you able to attend regular hospital appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the exact details will depend on which part of the study you are in. Generally, it will involve receiving a chemotherapy drug called Yondelis through a drip into your arm, usually at the same time as you have radiotherapy treatment. You will have regular visits to the hospital for these treatments and for check-ups.

During these visits, doctors and nurses will monitor your health closely, perform examinations, and take blood tests to see how you are responding to the treatment and to check for any side effects. There will also be scans, such as CT or MRI scans, to see how the tumour is reacting. After your treatment finishes, there will be follow-up appointments over several years to monitor your recovery and check if the cancer returns. The total duration of active treatment and follow-up will vary depending on your specific situation within the study.

Potential risks and benefits

Potential benefits of joining this study include receiving a new combination treatment for your soft tissue sarcoma, which might be more effective than standard treatments. You would also be helping doctors to learn more about how to treat this condition, which could benefit others in the future. However, there are potential risks, as all medical treatments can have side effects. These risks will be fully explained by the study team, and typically include those associated with Yondelis and radiotherapy, such as feeling unwell, tiredness, hair loss, and skin problems. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

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Unverified
Italy
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Unverified
Spain
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Unverified
France

Common questions

What is soft tissue sarcoma?

It's a rare type of cancer that starts in the body's soft tissues, like muscles, fat, blood vessels, nerves, and tendons.

What is Yondelis?

Yondelis is a chemotherapy drug that aims to stop cancer cells from growing and spreading.

What is radiotherapy?

Radiotherapy uses high-energy rays to kill cancer cells, often by damaging their DNA.

Why are they combining these two treatments?

Researchers hope that using Yondelis and radiotherapy together will make the treatment more powerful against soft tissue sarcoma than using either alone.

What does 'Phase I and II' mean?

These are early stages of testing. Phase I usually checks for safety and the best dose, while Phase II starts to look at how well the treatment works.