RecruitingPHASE1, PHASE2INTERVENTIONAL

FaR-RMS: An Overarching Study for Children and Adults With Frontline and Relapsed RhabdoMyoSarcoma

The FaR-RMS study is for children and adults who have rhabdomyosarcoma, a type of cancer. It's a big research project looking for better ways to treat this cancer, both when it's first found and if it comes back. Researchers are testing different combinations of chemotherapy drugs and radiotherapy. They want to see if new treatments, different timings for therapies, or changes to how radiotherapy is given can improve results and quality of life for patients. This study is designed to keep evolving, adding new treatments as new information becomes available.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

University of Birmingham

Enrolment target

1,672

Start

17 Sep 2020

Estimated completion

01 Jun 2030

Rhabdomyosarcoma

What is this study about?

The FaR-RMS study is a comprehensive research program for children and adults living with rhabdomyosarcoma, a type of cancer that develops from soft tissues. It's designed to find more effective treatments for people who are newly diagnosed, as well as for those whose cancer has returned.

This study is a bit like a collection of smaller studies, all working together under one main project. Researchers are looking at several key questions, such as whether new drug combinations work better, if changing how long 'maintenance' treatment is given makes a difference, and if tweaking the dose, area, or timing of radiotherapy can improve outcomes and a person's quality of life. They are also exploring new ways to understand how aggressive a person's cancer might be and how well treatments are working.

Because this is an 'over-arching' study, it means new treatment ideas and studies can be added over time based on the latest research and discoveries. The goal is to continuously improve how rhabdomyosarcoma is treated, helping more people achieve better health and well-being.

Key takeaways

Targets both new and recurring rhabdomyosarcoma.
Open to children and adults.
Tests various chemotherapy drugs and radiotherapy approaches.
Aims to improve treatment effectiveness and quality of life.
New treatment ideas can be added to the study over time.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be part of the FaR-RMS study, you need to have been diagnosed with rhabdomyosarcoma (but not a type called pleomorphic RMS), and you or your parent/guardian must agree to take part by signing a consent form. While it’s best to join when you're first diagnosed, you might still be able to join later, even if your cancer has returned.

For some specific parts of the study, like the 'IRIVA' group, there are more detailed rules. For example, you would typically need to be between 1 and 25 years old and have a specific type of 'very high risk' disease. You shouldn't have had any treatment for rhabdomyosarcoma yet, apart from surgery. Your body's organs, like your liver and kidneys, need to be working well, and your blood counts should be at a healthy level. If you are a woman who could get pregnant, you'd need to have a negative pregnancy test and agree to use contraception during and after the trial. Men also need to agree to use contraception if they are sexually active.

There are also reasons why someone might not be able to join. These include having a very low weight (under 10kg), severe ongoing diarrhoea, having had a stem cell transplant before, or having other serious health problems that might make the treatment unsafe. You couldn't join if you have a second cancer, are pregnant or breastfeeding, or have certain bladder issues.

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.

Have I been diagnosed with rhabdomyosarcoma (not pleomorphic RMS)?
Am I (or my legal guardian) willing to give written consent?
Am I generally healthy enough to receive strong cancer treatments?
If I am a woman of childbearing age, am I willing to use contraception?
Do I have healthy kidney and liver function?
Have I had a stem cell transplant before (this would likely make me ineligible)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the FaR-RMS study, your treatment will involve a combination of medicines like chemotherapy drugs (e.g., Irinotecan, Vincristine, Cyclophosphamide) and possibly radiotherapy. The exact treatments will depend on your specific situation and which part of the study you join.

You will have regular hospital visits for assessments, which might include blood tests, scans, and check-ups to see how you are responding to treatment and to monitor for any side effects. The study aims to look at different timings and doses of these treatments. The total duration of your participation will vary depending on the treatment plan you are on, but cancer treatments often last many months, followed by a period of observation.

Some patients might be suitable for more than one arm of the study at different times, depending on how their disease progresses.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and risks. A potential benefit of joining FaR-RMS is receiving treatments that could be more effective than standard care, based on the latest research. You would also be contributing to medical science, which could help future patients with rhabdomyosarcoma. However, there are also risks, as the treatments involve powerful medicines and radiotherapy, which can have side effects. These side effects can vary widely, from feeling unwell to more serious complications. The research team will explain all known side effects. It's very important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (128)

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

Queensland Children's Hospital
Verified postcode
Brisbane, Australia· Recruiting
Chris O'brien Lifehouse
Verified postcode
Camperdown, Australia· Recruiting
Monash Children's Hospital
Verified postcode
Clayton, Australia· Recruiting
Peter Maccallum Cancer Centre
Verified postcode
Melbourne, Australia· Recruiting
Royal Childrens Hospital Melbourne
Verified postcode
Melbourne, Australia· Recruiting
John Hunter Children's Hospital
Verified postcode
New Lambton Heights, Australia· Recruiting
Perth Children's Hospital
Verified postcode
Perth, Australia· Recruiting
Sydney Children's Hospital
Verified postcode
Sydney, Australia· Recruiting
The Childrens Hospital At Westmead
Verified postcode
Sydney, Australia· Recruiting
Westmead Hospital
Verified postcode
Westmead, Australia· Recruiting
Princess Alexandra Hospital
Verified postcode
Woolloongabba, Australia· Recruiting
Kepler University Clinic Linz
Verified postcode
Linz, Austria· Recruiting

Common questions

What is rhabdomyosarcoma?

Rhabdomyosarcoma is a rare type of cancer that forms in soft tissues, most commonly in muscles.

Can adults and children join this study?

Yes, this study is open to both children and adults with rhabdomyosarcoma.

Do I have to join the study right after being diagnosed?

It's best to join at diagnosis, but you might still be able to join later, even if your cancer has come back.

What kinds of treatments are being tested?

The study tests different chemotherapy drugs and radiotherapy to find the best ways to use them.

What if I change my mind about participating?

You can leave the study at any time, for any reason, and it won't affect your regular medical care.

How to find out more

Bridget Shaw

farrms@trials.bham.ac.uk 0121 414 2996 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.