Combination Chemotherapy With or Without Temsirolimus in Treating Patients With Intermediate Risk Rhabdomyosarcoma
This important study is investigating better treatments for rhabdomyosarcoma, a cancer that can form in soft tissues like muscles. Specifically, it's for patients whose cancer has an intermediate risk of returning after treatment. The study is comparing the usual chemotherapy treatment with a new approach: chemotherapy combined with an additional drug called temsirolimus. Researchers want to find out if adding temsirolimus to the standard chemotherapy makes the treatment more effective at stopping the cancer from growing, or at preventing it from coming back. By comparing these two treatments, the study aims to improve care for people with this type of cancer.
At a glance
Results
Results from this study
Posted October 2024Results have been published for this study.
What is this study about?
This study is about finding better ways to treat a type of cancer called rhabdomyosarcoma. This cancer can develop in soft tissues in the body, such as muscles. The study is specifically looking at patients who have an "intermediate risk" type of rhabdomyosarcoma. This means their cancer has an average chance of coming back after the initial treatment.
The main goal of this research is to compare two different treatment approaches. One approach is the standard chemotherapy, which is a combination of powerful medicines designed to kill cancer cells or stop them from growing. The second approach is the same standard chemotherapy, but with an extra drug called temsirolimus added in. Temsirolimus works by blocking certain things cancer cells need to grow, similar to how chemotherapy works but in a different way. The researchers want to see if adding temsirolimus makes the treatment work better than chemotherapy alone.
This is a 'Phase 3' study, which means it's a large study comparing a new treatment idea to one that's already in use. The hope is to discover if the new combination treatment can help patients live longer without their cancer returning, or improve their overall health outcomes. The information gained from this study could help doctors decide on the best treatments for rhabdomyosarcoma in the future.
Key takeaways
- This study evaluates if adding a drug called temsirolimus improves standard chemotherapy for rhabdomyosarcoma.
- It's for children, teenagers, and young adults with intermediate-risk rhabdomyosarcoma.
- Participation involves receiving chemotherapy and possibly temsirolimus, with regular check-ups.
- The main goal is to see if the new combination prevents cancer from returning for longer.
- All participants are closely monitored for health and potential side effects.
- It's a Phase 3 study, meaning it compares a new approach to current standard care.
Who may be eligible?
This study is looking for children, teenagers, and young adults with rhabdomyosarcoma. For most types of rhabdomyosarcoma, you need to be under 40 years old to join. If you have just been diagnosed with rhabdomyosarcoma, and it's not the 'adult-type pleomorphic' kind, you might be able to take part. The specific type, stage, and where the cancer is in your body will also determine if you qualify. For example, some types like embryonal rhabdomyosarcoma or alveolar rhabdomyosarcoma are included.
To join, you also need to be generally well enough to take part in the study treatments. Doctors will check your overall health and how effectively your blood, kidney, and liver are working through blood tests. They’ll also need to be able to get a sample of your cancer tissue for various tests. If you meet these general health requirements and your specific cancer type and stage fit the study criteria, you could be eligible.
It's really important to talk to your doctor or care team if you think you or your child might be eligible. They can look at your full medical history and all your test results to see if this study is an option 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.
- Are you or the patient under 40 years old?
- Have you recently been diagnosed with rhabdomyosarcoma (not adult-type pleomorphic)?
- Is your specific type and stage of rhabdomyosarcoma listed as eligible (e.g., certain embryonal or alveolar types)?
- Are you generally well enough for treatment, with good blood, kidney, and liver function?
- Can a sample of your cancer tissue be provided for study tests?
What does participation involve?
If you join this study, you would receive treatment that includes a combination of chemotherapy drugs like vincristine, dactinomycin, and cyclophosphamide, sometimes alternated with irinotecan or vinorelbine. Some participants will also receive temsirolimus, in addition to the chemotherapy. These drugs are usually given directly into a vein (intravenously) over a period of time, as injections or drips.
The study involves regular visits to the hospital for your treatments, which will be scheduled over many weeks or months. You will have various assessments, including blood tests and possibly scans, to monitor your health and how the treatment is working. You might also be asked to fill in questionnaires. Some patients may also receive radiation therapy as part of their overall treatment plan. The total duration of your participation, including follow-up, will be decided by the study doctors.
This study is comparing two different treatment groups, so you would be randomly assigned to one group, much like flipping a coin. You wouldn't be able to choose which treatment combination you receive.
Potential risks and benefits
Locations (382)
- Children's Hospital of AlabamaVerified postcodeBirmingham, United States
- USA Health Strada Patient Care CenterVerified postcodeMobile, United States
- Anchorage Associates in Radiation MedicineVerified postcodeAnchorage, United States
- Anchorage Radiation Therapy CenterVerified postcodeAnchorage, United States
- Alaska Breast Care and Surgery LLCVerified postcodeAnchorage, United States
- Alaska Oncology and Hematology LLCVerified postcodeAnchorage, United States
- Alaska Women's Cancer CareVerified postcodeAnchorage, United States
- Anchorage Oncology CentreVerified postcodeAnchorage, United States
- Katmai Oncology GroupVerified postcodeAnchorage, United States
- Providence Alaska Medical CenterVerified postcodeAnchorage, United States
- Kingman Regional Medical CenterVerified postcodeKingman, United States
- Banner Children's at DesertVerified postcodeMesa, United States
Common questions
What is rhabdomyosarcoma?
Rhabdomyosarcoma is a rare type of cancer that forms in soft tissues like muscles, tendons, or fat. It often affects children.
What is temsirolimus?
Temsirolimus is a drug that helps stop cancer cells from growing by blocking certain signals they need to multiply. It works differently from traditional chemotherapy.
What does 'intermediate risk' mean?
Intermediate risk means that based on features of the cancer, there's an average chance of it returning after initial treatment. This study is focused on this specific risk group.
Will I know which treatment I'm getting?
This is a 'randomised' study, meaning you would be put into one of the treatment groups by chance, like drawing numbers from a hat. You or your doctor may not know which specific treatment you are receiving until later.
Can I leave the study if I change my mind?
Yes, you can leave the study at any time, for any reason. Your decision will not affect your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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