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

ConditionRhabdomyosarcoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of Birmingham

About this trial

FaR-RMS is an over-arching study for children and adults with newly diagnosed and relapsed rhabdomyosarcoma (RMS)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed diagnosis of RMS (except pleomorphic RMS)

Written informed consent from the patient and/or the parent/legal guardian

Entered in to the FaR-RMS study at diagnosis

Very High Risk disease

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Irinotecan

    Drug

    antineoplastic enzyme inhibitor

  • Actinomycin D

    Drug

    Antineoplastic agent that is a polypeptide antibiotic

  • Doxorubicin

    Drug

    An anthracycline topoisomerase inhibitor isolated from streptpmyces peucetius var. casesius

  • Ifosfamide

    Drug

    chemotherapeutic agent chemically related to the nitrogen mustards and is a synthetic analog of cyclophosphamide

  • Vincristine

    Drug

    anti neoplastic vinca alkaloid agent

  • Vinorelbine

    Drug

    vinca alkaloid with a role as an antineoplastic agent

  • Cyclophosphamide

    Drug

    Precursor of an alkylating nitrogen mustard antineoplastic and immunosuppressive agent

  • Temozolomide

    Drug

    oral antineoplastic alkylating agent

  • radiotherapy

    Radiation

    Ionising radiation

  • Regorafenib

    Drug

    Oral multi-kinase inhibitor that targets a broad range of angiogenic, stromal and oncogenic kinases, including vascular endothelial growth factor receptors (VEFGR) 1, 2 and 3, tyrosine kinase with immunoglobulin and epidermal growth factor homology domain 2 (TIE2), platelet-derived growth factor receptor (PDGFR), fibroblast growth factor receptors (FGFR), c-KIT, RET, RAF-1 and BRAF (wild-type and V600E mutant).

Treatment groups

1,672 Participants
are divided into 19 treatment groups

19

Treatment groups

See each treatment group below.

Group A: Phase 1b Dose finding: VHR induction - IRIVAExperimental treatment 4 interventions
Group B: CT1A: VHR induction - IVADOActive comparator 4 interventions
Group C: CT1A: VHR Induction IRIVAExperimental treatment 4 interventions
Group D: CT1B: HR Induction IVAActive comparator 3 interventions
Group E: CT1B: HR Induction IRIVAExperimental treatment 4 interventions
Group F: RT1A: Preoperative RadiotherapyExperimental treatment 1 intervention
Group G: RT1A: Post operative radiotherapyActive comparator 1 intervention
Group H: RT1B: Radiotherapy for resectable disease: dose escalatedExperimental treatment 1 intervention
Group I: RT1B: Radiotherapy for resectable disease: standard doseActive comparator 1 intervention
Group J: RT1C: Radiotherapy for unresectable disease: dose escalatedExperimental treatment 1 intervention
Group K: RT1C: Radiotherapy for unresectable disease: standard doseActive comparator 1 intervention
Group L: RT2: Radiotherapy to primary tumour and involved lymph nodesExperimental treatment 1 intervention
Group M: RT2: Radiotherapy to all metastatic sitesExperimental treatment 1 intervention
Group N: CT2A: VHR Maintenance - VCExperimental treatment 2 interventions
Group O: CT2A: Maintenance -Stop treatmentNo intervention 0 interventions
Group P: CT2B: HR Maintenance - VCExperimental treatment 2 interventions
Group Q: CT2B: HR Maintenance - Stop TreatmentNo intervention 0 interventions
Group R: CT3: Relpased Chemotherapy - VIRTActive comparator 3 interventions
Group S: CT3: Relapsed Chemotherapy - VIRRExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Event Free Survival (RT2)

Failure events are: * Relapse or progression of existing disease, or occurrence of disease at new sites, * Death from any cause without disease progression, * Second malignant neoplasm

Time frame
From randomisation to first failure event, timeframe 36 months
2

Event Free Survival (CT1A)

Failure events are: * Relapse or progression of existing disease, or occurrence of disease at new sites, * Death from any cause without disease progression, * Second malignant neoplasm

Time frame
From randomisation to first failure event, timeframe 36 months
3

Event Free Survival (CT1B)

Failure events are: * Relapse or progression of existing disease, or occurrence of disease at new sites, * Death from any cause without disease progression, * Second malignant neoplasm

Time frame
From randomisation to first failure event, timeframe 36 months
4

Event Free Survival (CT2A)

Failure events are: * Relapse or progression of existing disease, or occurrence of disease at new sites, * Death from any cause without disease progression, * Second malignant neoplasm

Time frame
From randomisation to first failure event, timeframe 36 months

Secondary outcomes

1

Recommended Phase II Dose (Phase 1b)

Based on tolerability, where tolerability is evaluated through the occurrence of dose limiting toxicity (DLT).

Time frame
From first patient first visit in dose finding study until appropriate dose level found, estimated 9 months
2

Maximum Tolerated Dose (Phase 1b)

Dose level at which no or one participant experiences a DLT when at least two of three to six participants experience a DLT at the next highest dose.

Time frame
From first patient first visit in dose finding study until appropriate dose level
3

Toxicity (All chemotherapy randomisations)

Categorised and graded using Common Terminology Criteria for Adverse Events

Time frame
From date of protocol defined treatment until 30 days after the administration of the last treatment
4

Dose Limiting Toxicity (Phase 1b)

Diarrhoea: Grade 3 for \>3 days despite loperamide therapy Diarrhoea: Grade 4 despite loperamide therapy. Enterocolitis: Grade 3 or above Ileus: Grade 3 or above for more than 3 days Oral mucositis: Grade 3 above for \>3 days despite optimal supportive care Persistent neutropenia or thrombocytopenia leading to delay of start of next course by \>7 days; i.e. starting \> day 28 Any grade 3 or 4 toxicity resulting in discontinuation of the new combination Any grade 5 toxicity

Time frame
From commencement of treatment until 21 days after the start of cycle 2 (each cycle is 21 days)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Birmingham

Lead sponsor

Source ClinicalTrials.gov
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