What is this study trying to find out about rhabdomyosarcoma?

This study evaluates new drug regimens, radiotherapy approaches, and genetic and imaging markers to improve treatment outcomes for children and adults with rhabdomyosarcoma. Researchers want to understand how different therapies affect survival and quality of life. The University of Birmingham sponsors this research to advance care in this rare cancer.

Who may be eligible for this rhabdomyosarcoma clinical trial?

Patients of all genders who have a confirmed diagnosis of rhabdomyosarcoma may be eligible, typically between 6 months and 25 years old depending on the treatment group. Participants must be medically fit, not pregnant or breastfeeding, and have no recent stem cell transplant. Please review eligibility criteria for more details.

Is there any cost to participate in this rhabdomyosarcoma clinical trial?

Study-related care, including all treatments and trial visits, is provided at no cost. Personal travel and other expenses may vary and are not guaranteed to be covered during the trial.

Actively Recruiting

Phase 1

Phase 2

All Genders

ID04625907

FaR-RMS Study Treatment and Research for Children and Adults with New or Relapsed Rhabdomyosarcoma

Led by University of Birmingham · Updated on 2024-05-23

1672

Participants Needed

128

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating new treatment strategies for children and adults with newly diagnosed and relapsed rhabdomyosarcoma RMS in a multi-arm, multi-stage clinical trial called FaR-RMS. The study aims to assess the impact of new drug regimens, the effects of changing maintenance therapy duration, the influence of radiotherapy dose and timing, and the use of genetic and imaging markers to improve risk stratification and predict outcomes. Participants may receive various chemotherapy drugs including irinotecan, ifosfamide, vincristine, actinomycin, doxorubicin, vinorelbine, cyclophosphamide, temozolomide, and regorafenib administered through infusions or oral tablets on specific schedules. Radiotherapy is also given in different doses and timings depending on the treatment arm. The study includes dose-finding phases and multiple randomizations based on patient risk group and disease status. Throughout the study, participants undergo regular assessments including monitoring for event-free survival, local failure-free survival, toxicity, response to treatment, and quality of life using questionnaires. Follow-up may continue for several years to track progression and survival. Safety is closely monitored with evaluations of acute and late complications, and treatment tolerability is assessed. The study involves written consent and requires participants to use contraception if applicable during and after treatment.

CONDITIONS

Brief Title

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

Who Can Participate

All Genders

Eligibility Criteria

You may qualify if you...

Histologically confirmed diagnosis of RMS (except pleomorphic RMS)
Written informed consent from the patient and/or the parent/legal guardian
For Phase 1b Dose Finding - entered at diagnosis, very high risk disease, age over 12 months and up to 25 years, no prior treatment except surgery, medically fit, adequate liver and kidney function, adequate blood counts, negative pregnancy test if applicable, agreement to use contraception
For Frontline chemotherapy randomisations (Very High Risk CT1a, High Risk CT1b) - entered at diagnosis, risk group criteria met, age 6 months or older, available for randomisation within 60 days post biopsy/surgery, no prior treatment except surgery, medically fit, adequate liver function and blood counts, negative pregnancy test if applicable, agreement to use contraception
For Radiotherapy randomisations - entered into FaR-RMS, risk groups Very High Risk, High Risk or Standard Risk, age 2 years or older, receiving frontline induction treatment, medically fit, negative pregnancy test if applicable, agreement to use contraception
For Maintenance chemotherapy randomisations (CT2a, CT2b) - entered into FaR-RMS, risk group criteria met, completed required cycles of maintenance treatment without progressive disease or severe neuropathy, medically fit, agreement to use contraception
For Relapsed Chemotherapy (CT3) - entered into FaR-RMS, first or subsequent relapse of histologically verified RMS, age 6 months or older, measurable disease, no recent chemotherapy or investigational treatment, medically fit, negative pregnancy test if applicable, agreement to use contraception

You will not qualify if you...

Weight less than 10 kg
Active diarrhea grade greater than 2 (or greater than 1 for relapsed chemotherapy)
Prior allogeneic or autologous stem cell transplant
Uncontrolled illness or active infection
Pre-existing medical condition preventing treatment
Urinary outflow obstruction not relieved before treatment
Active inflammation of the urinary bladder (cystitis)
Known allergy to any treatments or excipients
Second malignancy
Pregnant or breastfeeding women
Receiving radiotherapy as brachytherapy (for radiotherapy randomisations)

Research Team

Bridget Shaw

Emma Gray

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FaR-RMS Study Treatment and Research for Children and Adults with New or Relapsed Rhabdomyosarcoma

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria