Benefit of Intensified Peri-operative Chemotherapy Within High-risk CINSARC Patients With Resectable Soft-tissue Sarcomas
This study is for adults with a high-risk type of soft-tissue sarcoma that hasn't spread and can be removed by surgery. Researchers want to find out if giving more chemotherapy before surgery (6 cycles instead of 3) helps prevent the cancer from coming back or spreading in the long term. Participants will be randomly assigned to either receive the standard 3 cycles of chemotherapy or 6 cycles, both followed by surgery and possibly radiotherapy. The main goal is to see if the extra chemotherapy improves how long people live without the cancer spreading. For those with a lower-risk sarcoma, there's also a separate part of the study where treatment is decided by their doctor.
At a glance
What is this study about?
This research study is trying to find the best way to treat a type of cancer called "soft-tissue sarcoma," specifically in people who have a "high-risk" form of the disease. Soft-tissue sarcomas are rare cancers that can grow in muscles, fat, blood vessels, or other soft tissues of the body. "High-risk" means there's a higher chance the cancer might spread or come back after treatment. The good news is that for this study, the cancer hasn't spread to other parts of the body (non-metastatic) and doctors believe it can be completely removed with surgery (resectable).
Currently, the standard treatment often involves chemotherapy (cancer-fighting drugs) before surgery, usually for 3 cycles, followed by the operation and sometimes radiation therapy. This study wants to see if adding more chemotherapy, specifically 3 extra cycles for a total of 6 cycles before surgery, can make a difference. The main aim is to see if this intensified treatment can stop the cancer from spreading to other parts of the body, also known as metastatic progression, three years after treatment.
There are two main groups in the study for high-risk patients. One group will get the standard treatment (3 cycles of chemotherapy, then surgery and possibly radiotherapy). The other group will get the experimental treatment (6 cycles of chemotherapy, then surgery and possibly radiotherapy). They'll decide which group you're in by chance, like flipping a coin. This helps make sure the results are fair. For people with a lower-risk sarcoma, there's also a part of the study where doctors will decide the best treatment for each patient individually.
Key takeaways
- This study is for adults with high-risk soft-tissue sarcoma that hasn't spread and can be surgically removed.
- It compares 3 cycles of pre-surgery chemotherapy to 6 cycles to see if more chemo is better.
- The main goal is to prevent the cancer from spreading over three years.
- Participants will be randomly assigned to one of the two treatment groups.
- There are specific health and tumour requirements for joining the study.
Who may be eligible?
To be part of this study, you generally need to be at least 18 years old and have a soft-tissue sarcoma that has been confirmed by specialists and is considered "high-risk." The cancer must not have spread to other parts of your body, and your doctors must believe it can be removed with surgery. You shouldn't have had any treatment for this specific cancer before.
Your general health also matters. You should be well enough to take part in daily activities without much trouble, and your doctors expect you to live at least another three months. If you are a woman who could become pregnant, you'll need to have a negative pregnancy test and agree to use reliable birth control during the study and for a year afterwards. Men also need to use effective birth control.
There are some reasons why you might not be able to join. For example, if you have certain rare types of soft-tissue sarcoma, or if you've had another cancer diagnosed or treated within the last two years (unless it was a very early-stage cancer that was completely removed). The study will also check specific details about your tumour to make sure it fits their criteria.
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 at least 18 years old?
- Has your soft-tissue sarcoma been confirmed by specialists, and is it a 'high-risk' type?
- Has your cancer *not* spread to other parts of your body?
- Have you *not* had any previous treatment for this specific cancer?
- Are you generally well enough to do most daily activities?
What does participation involve?
If you join this study, your commitment will involve several appointments, treatments, and follow-ups over time. For high-risk patients, you would either receive 3 or 6 cycles of doxorubicin-based chemotherapy over several weeks before your surgery. Each cycle involves specific drug infusions and recovery periods. After your chemotherapy, you would have surgery to remove the tumour, and your doctors might decide you also need radiotherapy.
Throughout the study, you'll have regular hospital visits for check-ups, blood tests, and scans to monitor your health and the cancer. These visits will be more frequent during the treatment phase. After your initial treatment, you'll continue to have follow-up appointments to track your health and screen for any signs of the cancer returning or spreading. The main follow-up for the study will last for three years after your treatment ends, but your overall medical care would continue beyond that. The specific number of visits and tests will be detailed by the study team.
Potential risks and benefits
Locations (10)
- Institut BergonieVerified postcodeBordeaux, France· Recruiting
- Centre Georges François LeclercVerified postcodeDijon, France· Recruiting
- CHU DupuytrenVerified postcodeLimoges, France· Recruiting
- Centre Léon BérardVerified postcodeLyon, France· Recruiting
- Institut Paoli CalmettesVerified postcodeMarseille, France· Recruiting
- Insitut du CancerVerified postcodeMontpellier, France· Recruiting
- Institut de Cancérologie de l'Ouest - Site René GauducheauVerified postcodeSaint-Herblain, France· Recruiting
- CHRU StrasbourgVerified postcodeStrasbourg, France· Recruiting
- Institut Claudius RegaudVerified postcodeToulouse, France· Recruiting
- Institut Gustave RoussyVerified postcodeVillejuif, France· Not yet recruiting
Common questions
What is soft-tissue sarcoma?
It's a rare type of cancer that grows in soft body tissues like muscle, fat, or blood vessels.
What does 'non-metastatic and resectable' mean?
It means the cancer hasn't spread to other parts of your body and doctors believe they can completely remove it with surgery.
What is chemotherapy?
Chemotherapy is medicine used to kill cancer cells, often given through an IV (drip).
Why is there a 'high-risk' and 'low-risk' group?
The study focuses on high-risk patients, as they are more likely to benefit from new treatments. Low-risk patients are followed separately to understand their outcomes.
How long will I be followed after treatment?
The main part of the study will follow your health for three years after your initial treatment.
How to find out more
Antoine ITALIANO, MD, PhD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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