FaR-RMS : An overarching study for children and adults with Frontline and Relapsed RhabdoMyoSarcoma

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Multiple<Br/>Treatment TypesTypeMultiple
Treatment Types

One/TwoPhase One/Two

0+Age Over 0

Sarcoma<br/>CancersCancer LocationSarcoma
Cancers

Multiple treatment types,Radiotherapy,Systemic therapy | SarcomaRhabdomyosarcoma,Sarcoma

Trial Overview Read MoreRead more

This study is evaluating the impact of new cancer treatments in both newly diagnosed and relapsed rhabdomyosarcoma patients; it will determine whether changing the duration of maintenance therapy affects outcome; and whether changes to dose, extent and timing of radiotherapy improve outcomes and quality of life for patients.
 

This trial is treating patients with Rhabdomyosarcoma.

This is a systemic therapy and radiotherapy trial.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

  • 2018-000515-24, ISRCTN45535982

Scientific Title

An overarching study for children and adults with Frontline and Relapsed RhabdoMyoSarcoma

Other Non-Commercial Sponsor

University of Birmingham & Cancer Research UK

Summary

The first part of this study will be a phase Ib dose-finding trial, open to newly diagnosed patients. This study will investigate the addition of irinotecan to IVA (ifosfamide, vincristine and actinomycin D) chemotherapy (IrIVA) and support the identification of a recommended phase II dose. Once the recommended phase II dose has been determined, patients will be randomised, according to whether they are newly diagnosed or high risk, into the next part of the study. In this part of the study, newly diagnosed patients will be randomised to receive either IVADo (Ifosfamide, Vincristine, Actinomycin D, Doxorubicin) or IrIVA; and high risk patients will be randomised to IVA or IrIVA. Cycles of chemotherapy will be given at 21-day intervals. The next part of the study will contain several radiotherapy randomisations for patients with newly diagnosed and high risk rhabdomyosarcoma, followed by maintenance chemotherapy. Following the completion of treatment, the frequency of follow-up assessments will be guided by local practice. However, every 3 months for the first 3 years and every 6 months thereafter is suggested. Patients will be followed-up for a minimum of 3 years, until the last patient has been followed-up for 3 years.

Recruiting Hospitals Read MoreRead more

Royal Childrens Hospital
Parkville
Trial Coordinator
CCC.ClinicalTrials@rch.org.au

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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