Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma
This study, called STRASS 2, is for people in the UK with high-risk retroperitoneal sarcoma, specifically certain types of liposarcoma or leiomyosarcoma. Doctors want to find out if giving chemotherapy before surgery (called 'preoperative chemotherapy') works better than surgery alone. They'll compare how long people live without their cancer returning in both groups. The chemotherapy used depends on the type of sarcoma. This is a "Phase 3" study, meaning it's a large trial testing if a new treatment approach is better than the standard one. Participants will be randomly assigned to either receive chemotherapy first or go straight to surgery.
At a glance
What is this study about?
Imagine you have a rare type of cancer called retroperitoneal sarcoma, which grows in the back of your tummy area. Doctors are always looking for the best way to treat these cancers. This study is trying to answer a really important question: for certain types of this sarcoma, is it better to have chemotherapy first, before surgery, or just have surgery directly?
This trial is called STRASS 2, and it's a "Phase 3" study. This means it's a big, carefully designed study to see if a new way of treating cancer is better than what's currently considered standard. Half of the people in the study will have surgery as they normally would. The other half will have a course of chemotherapy first, and then have their surgery a few weeks later. The main goal is to see if having chemotherapy before surgery helps people live longer without their cancer coming back.
By comparing these two approaches, doctors hope to learn if chemotherapy before surgery can improve the chances of a successful outcome for people with high-risk retroperitoneal sarcoma. This information is vital for helping future patients make informed decisions about their treatment plans and could change how these cancers are treated in the future.
Key takeaways
- This study compares chemotherapy before surgery versus surgery alone for specific retroperitoneal sarcomas.
- It's a 'Phase 3' trial, the final stage before a treatment might be widely adopted.
- Participants are randomly assigned to one of two treatment groups.
- The main goal is to see if chemotherapy before surgery improves how long patients live without their cancer returning.
- Eligibility is strict, based on the type, size, and location of the tumour.
- You can withdraw from the study at any time without affecting your normal care.
Who may be eligible?
To join this study, your doctor will need to confirm you have a specific type of retroperitoneal sarcoma. This includes certain high-risk types of leiomyosarcoma (LMS) or liposarcoma (LPS) that started in your tummy or pelvis area. Your tumour also needs to be a certain size or show specific features when looked at under a microscope or with genetic tests. For example, LMS tumours need to be at least 5cm.
Crucially, your doctors must believe that your tumour can be fully removed by surgery. They will use scans like CT and MRI to decide this. If the cancer has grown into very important structures like major blood vessels, the spine, or too many other organs, then it wouldn't be suitable for this study. The doctors also need to be able to measure your tumour clearly on scans.
Finally, you need to be at least 18 years old, and tissue from your tumour must be collected for expert review. Your medical team will carefully check all these requirements to make sure the study is right for you.
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 a primary high-risk leiomyosarcoma (LMS) or dedifferentiated liposarcoma (LPS) in your tummy/pelvis area?
- Is your tumour considered fully removable by surgery by your local sarcoma team?
- Are you at least 18 years old?
- Has your tumour been clearly identified and measured on scans?
- Are you able to provide a tissue sample from your tumour for review?
What does participation involve?
If you join this study, you'll be randomly assigned to one of two groups, like flipping a coin. You won't get to choose which group you're in.
If you're in the 'standard' group, you'll have surgery to remove your tumour within about 4 weeks of joining the study.
If you're in the 'experimental' group, you'll have three cycles of chemotherapy first, starting within 2 weeks of joining the study. The specific chemotherapy drugs will depend on your type of sarcoma. After the chemotherapy, your doctors will check your tumour again to make sure surgery is still possible. Then, you'll have surgery within 3 to 6 weeks after your last chemotherapy treatment. The total duration of your participation in the study itself isn't specified, but it would involve regular follow-up appointments and scans after surgery to monitor your health and check for any cancer recurrence.
Potential risks and benefits
Locations (169)
- University of Alabama at Birmingham Cancer CenterVerified postcodeBirmingham, United States· Withdrawn
- Mayo Clinic Hospital in ArizonaVerified postcodePhoenix, United States· Recruiting
- City of Hope Comprehensive Cancer CenterVerified postcodeDuarte, United States· Recruiting
- UCI Health-Chao Family Comp CC and Ambulatory CareVerified postcodeIrvine, United States· Recruiting
- UC San Diego Moores Cancer CenterVerified postcodeLa Jolla, United States· Recruiting
- UC Irvine Health/Chao Family Comprehensive Ca CtrVerified postcodeOrange, United States· Recruiting
- UCHealth University of Colorado HospitalVerified postcodeAurora, United States· Recruiting
- Smilow Cancer Hospital-Derby Care CenterVerified postcodeDerby, United States· Recruiting
- Smilow Cancer Hospital Care Center-FairfieldVerified postcodeFairfield, United States· Recruiting
- Smilow Cancer Hospital Care Center at GlastonburyVerified postcodeGlastonbury, United States· Recruiting
- Smilow Cancer Hospital Care Center at GreenwichVerified postcodeGreenwich, United States· Recruiting
- Smilow Cancer Hospital Care Center - GuifordVerified postcodeGuilford, United States· Recruiting
Common questions
What does 'retroperitoneal' mean?
It means the cancer is in the area at the back of your tummy (abdomen) and pelvis, behind the lining of your abdominal cavity.
What is 'randomised'?
It means you'll be put into one of the study groups by chance, like drawing lots or flipping a coin. Neither you nor your doctor can choose which group you're in.
What is 'neoadjuvant chemotherapy'?
This is chemotherapy given before surgery. The aim is often to shrink the tumour or kill any cancer cells that might have spread, making the surgery more effective.
What's the difference between Liposarcoma and Leiomyosarcoma?
These are two different types of soft tissue sarcoma. Liposarcoma grows from fat cells, and Leiomyosarcoma grows from smooth muscle cells.
Will I know which treatment I'm getting?
Yes, this is an 'open label' study, meaning both you and your doctors will know whether you are receiving chemotherapy before surgery or going straight to surgery.
How to find out more
EORTC HQ
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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