FaR-RMS

FaR-RMS is intended to be a rolling programme of research, with new treatment arms introduced as emerging data and innovation inform.

This study has multiple aims.

It aims to evaluate the impact of new agent regimens in both newly diagnosed and relapsed RMS; whether changing the duration of maintenance therapy affects outcome; and whether changes to dose, extent (in metastatic disease) and timing of radiotherapy improve outcome and quality of life.

In addition the study will evaluate risk stratification through the use of PAX-FOXO1 fusion gene status instead of histological subtyping and explore the use of FDG PET-CT response assessment as a prognostic biomarker for outcome following induction chemotherapy.

Newly diagnosed patients should, where possible, be entered into the FaR-RMS study at the time of first diagnosis prior to receiving any chemotherapy. However, patients can enter at the point of radiotherapy or maintenance, and those with relapsed disease can enter the study even if not previously entered at initial diagnosis. Patients may be entered into more than one randomisation/registration, dependant on patient risk group and disease status. 

Please note that the trials team cannot give individuals clinical advice. Patients and their families should contact their treating physician to discuss trials for which they may be eligible

Chief Investigator: Dr Julia Chisholm
Coordinating Sponsor: University of Birmingham
Funders: Bayer and CRUK (Cancer Research UK)
Disease Site: Muscle
Trial Type: Open, randomised, multicentre, international
Status: Open
UKCRN Study ID: 42490
Open to new sites? Yes
Recruitment start date: September 2019
Anticipated Recruitment end date: September 2027
CRCTU Trial Management Team: Children's Cancer Trials Team
Trial E-mail Address: farrms@trials.bham.ac.uk

 

Medical imaging plays a crucial role in the care of Rhabdomyosarcoma (RMS). Imaging can play a role in detecting the tumour, determining how far it has spread, monitoring treatment progress, and follow-up after treatment.

The FaR-RMS study includes two imaging studies that evaluate different medical imaging techniques to improve patient care.

Traditionally, doctors have measured tumour shrinkage after chemotherapy to assess treatment response. However, research shows this is not a reliable way to predict long-term outcomes. Therefore, it is not possible to change to a different therapy based on tumour size changes. This means that, because researchers can evaluate new treatments only by measuring how long patients remain disease-free or survive after treatment, clinical trials take many years to enrol enough patients and collect follow-up data to determine whether new treatments actually work.

The FaR-RMS trial is testing whether two types of modern imaging can predict treatment success much earlier:

• FDG-PET study
• Diffusion-weighted MRI study

FDG-PET Study:

This technique measures the amount of radioactive glucose absorbed by the tumour at diagnosis and after three cycles of chemotherapy. Tumour cells are cells which grow and multiply when they shouldn’t. This requires a lot of sugar. When chemotherapy works, we expect the tumour to absorb less radioactive sugar as the tumour cells become less vital.

Diffusion-weighted MRI Study:

This method looks at how water molecules move through tumour tissue at diagnosis and after three cycles of chemotherapy. When chemotherapy works, and the tumour cells break down, we expect water molecules to move more freely through the tissue.

What makes these studies special is that imaging data from different hospitals around the world will be collected and analysed in one central location. This allows for better quality control and more precise computer analysis. We have created detailed guidelines to ensure that all participating hospitals perform the scans consistently. This is especially important since rhabdomyosarcoma is a rare cancer.

Our goal:

The goal for both the FDG-PET and diffusion-weighted MRI studies is to develop new imaging techniques to determine whether treatments for rhabdomyosarcoma are working. First, to help doctors make better treatment decisions at an earlier stage of the disease, and second, to speed up the development of new therapies.