Active not recruitingPHASE2INTERVENTIONAL

Clinical and Biological Activity of an Anti-PD-L1 (Atezolizumab) in Operable Localised Soft Tissue Sarcomas Patients to be Treated With Radiotherapy

This study is for people with soft tissue sarcoma, a type of cancer that can be safely removed by surgery. It aims to find the best way to combine standard treatments – radiotherapy (radiation therapy) and surgery – with a new anti-cancer drug called atezolizumab. Atezolizumab works by helping your body's immune system fight cancer. Patients will be split into three groups by chance, each receiving the treatments in a different order. For example, some will get radiotherapy first, then the drug, then surgery, while others will have the drug first, then surgery, then radiotherapy. The main goal is to see which order of treatment works best to control the cancer and understand its effects on the body.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Centre Leon Berard

Enrolment target

Start

01 Aug 2018

Estimated completion

30 Dec 2026

Sarcoma,Soft Tissue

What is this study about?

This research study is about finding better ways to treat soft tissue sarcoma, which is a type of cancer that grows in soft tissues like muscles, fat, and blood vessels. If you have been diagnosed with this type of cancer and surgeons believe it can be removed, this study might be relevant to you. The study focuses on combining standard treatments, which are radiotherapy (using high-energy rays to kill cancer cells) and surgery (removing the tumour), with a new drug called atezolizumab. Atezolizumab is a type of immunotherapy, meaning it helps your own immune system recognise and fight the cancer cells.

The main idea behind this study is to test if the order in which these treatments are given makes a difference to how well they work. Patients taking part will be randomly assigned to one of three groups. Each group will receive radiotherapy, atezolizumab, and surgery, but the sequence will be different for each group. For example, one group might have radiotherapy first, then the drug, then surgery; another might have the drug first, then surgery, then radiotherapy; and the third might have radiotherapy first, then surgery, then the drug. By comparing these different sequences, the researchers hope to identify the most effective way to use these treatments together.

This is a 'Phase 2' trial, which means it's an early-stage study designed to check if the new treatment approach is safe and whether it shows promise in shrinking tumours or slowing cancer growth. It's an important step in developing new and more effective treatments for soft tissue sarcoma. The researchers will also collect tissue samples from your tumour before and during the study to learn more about how the treatments affect the cancer at a biological level.

Key takeaways

Tests a new drug (atezolizumab) for soft tissue sarcoma.
Combines drug with surgery and radiotherapy.
Explores different treatment sequences to find the best one.
Participation involves being randomly assigned to one of three treatment groups.
Requires regular hospital visits and follow-up for at least one year.

Who may be eligible?

To join this study, you need to be at least 18 years old. You must have been diagnosed with a soft tissue sarcoma and your doctors must believe that the tumour can be successfully removed by surgery. This could be a new diagnosis or if your cancer has come back locally and can still be operated on.

The cancer should be either high-grade (more aggressive) and not spread to other parts of the body, or intermediate to low-grade if the tumour is 5 centimetres or larger. You'll also need to be well enough to take part, meaning you can carry out most of your normal daily activities without much difficulty. Your blood test results, which check how well your organs like kidneys and liver are working, must also be within certain healthy ranges.

To help researchers understand your cancer, you’ll need to have at least one part of your tumour that is big enough (at least 1 cm across) for doctors to safely take a small biopsy sample using a needle. This process helps them study the tumour closely before and during treatment.

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 that your doctors say can be surgically removed?
Are your doctors able to take a small sample (biopsy) from your tumour safely?
Are your general health and organ functions, as shown by recent blood tests, within healthy limits?
Can you do most of your daily activities without much trouble?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be randomly placed into one of three treatment groups. This choice is made by chance, like flipping a coin, to ensure a fair comparison. Each group will receive a combination of radiotherapy, two doses of the study drug atezolizumab, and surgery. The order of these treatments will be different depending on which group you are in.

Atezolizumab is given through a drip into your vein every three weeks, for a total of two times. Radiotherapy will be given five days a week for five weeks in total. Surgery will be performed by your medical team in the usual way. Throughout the study, you'll have regular hospital visits for check-ups, blood tests, and scans to monitor your health and how the treatment is working. After finishing the main treatments, you will have follow-up appointments, starting two weeks after treatment, then at 18 weeks, 24 weeks, and every three months after that until your cancer either returns, you pass away, or you can no longer be followed up. The minimum follow-up will be for one year.

Potential risks and benefits

Taking part in a clinical trial means you might benefit from receiving a new drug or treatment approach that isn't widely available yet, which could be more effective than standard care. You'll also be closely monitored by a healthcare team. However, there are potential risks, as atezolizumab can cause side effects, and radiotherapy and surgery also have their own set of known risks. These will be fully explained by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (6)

Institut Bergonie
Verified postcode
Bordeaux, France
Centre Oscar Lambret
Verified postcode
Lille, France
Centre Léon Bérard
Verified postcode
Lyon, France
Institut Claudius Regaud
Verified postcode
Toulouse, France
Institut Gustave Roussy
Verified postcode
Villejuif, France
Royal Marsden Hospital
Verified postcode
London, United Kingdom

Common questions

What is soft tissue sarcoma?

It's a type of cancer that starts in soft tissues of the body, such as fat, muscle, nerves, blood vessels, and fibrous tissues.

What is atezolizumab?

It's a new drug that helps your body's own immune system find and fight cancer cells.

Why is the order of treatment being changed?

Researchers want to find out if giving radiotherapy, atezolizumab, and surgery in a different sequence can make the overall treatment more effective for your cancer.

Will I know which treatment order I'm getting?

Yes, this is an 'open-label' study, meaning both you and your doctors will know which treatment sequence you are receiving.

How long will I be followed after treatment?

You will have follow-up appointments for at least one year after your main treatments end, and potentially longer to monitor your health.