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SNCTP000004598 | EUCTR2018-000515-24 | BASEC2021-01257

Eine Studie für Kinder und Erwachsene mit neu diagnostiziertem oder rezidiviertem Rhabdomyosarkom (RMS)

Base de données : BASEC (Importation du 11.11.2024), WHO (Importation du 07.11.2024)
Modifié: 3 oct. 2024 à 01:00
Catégorie de maladie: Autres cancer

Brève description de l’étude (Source de données: BASEC)

Das RMS ist ein sogenannter Weichteiltumor, der z. B. von Muskel- oder Fasergewebe ausgeht und vor allem bei Kindern, aber auch bei Jugendlichen und Erwachsenen auftritt. Bei den meisten Patientinnen und Patienten besteht die RMS-Behandlung aus intensiver Chemotherapie, Operation und Bestrahlung. Bei der FaR-RMS Studie handelt es sich um eine von Wissenschaftlerinnen und Wissenschaftlern initiierte (nicht-kommerzielle) internationale klinische Studie. Mit der FaR-RMS-Studie möchte man verschiedene Strategien untersuchen, um mit einer Anpassung der Chemo- und Strahlentherapie die Behandlungsergebnisse bei Patientinnen und Patienten mit RMS zu verbessern. Darüber hinaus werden biologische Aspekte des RMS erforscht, um die genetische Struktur von RMS-Zellen besser zu verstehen. Die FaR-RMS Studie besteht aus mehreren Teilen. Im ersten Teil der Studie werden Tumorproben biologisch untersucht. Dabei werden einerseits im Rahmen von Forschungsprojekten neue Informationen über das RMS gesammelt. Andererseits werden die Patientinnen und Patienten aufgrund der Untersuchungsergebnisse für die weitere Behandlung in Risikogruppen eingeteilt.

Maladies étudiées(Source de données: BASEC)

Rhabdomyosarkom (RMS)

Health conditions (Source de données: WHO)

Rhabdomyosarcoma
MedDRA version: 20.0Level: PTClassification code 10039022Term: RhabdomyosarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps);Therapeutic area: Diseases [C] - Cancer [C04]

Maladie rare (Source de données: BASEC)

Non

Intervention étudiée (p. ex., médicament, thérapie, campagne) (Source de données: BASEC)

Im zweiten Teil der Studie werden die Patientinnen und Patienten gemäss ihrer zugeteilten Risikogruppe behandelt. Im Prinzip besteht die Studie aus fünf Abschnitten:
1) Phase 1b (Festlegung der Dosis von neuen Medikamentenkombinationen, beendet).
2) Induktionschemotherapie (erste Behandlung um den Tumor kleiner zu machen). Testung der in der Phase 1b identifizierten Kombinationen.
3) Bestrahlung
4) Erhaltungschemotherapie (Erhaltung oder Verbesserung der zuvor erzielten Therapieergebnisse)
5) Chemotherapie im Falle eines Rückfalls.
Je nach zugeteilter Risikogruppe gibt es für die Patientinnen und Patienten innerhalb der fünf Abschnitte unterschiedliche Behandlungspläne. Diese Behandlungspläne sind in ihrer Stärke und Intensität auf die jeweilige Risikogruppe abgestimmt. Patientinnen und Patienten mit einem geringeren Risiko erhalten dabei weniger intensive Behandlungen. Mit jedem der Behandlungspläne möchten die Forschenden eine Fragestellung beantworten. Dazu gibt es von jedem Behandlungsplan zwei Varianten, welche miteinander verglichen werden. Patientinnen und Patienten werden per Zufall einer der beiden Varianten zugeteilt.
Die Fragestellungen untersuchen unter anderem:
1) Die Wirksamkeit von neuen Medikamentenkombinationen
2) Die Wirksamkeit von höheren Bestrahlungsintensitäten
3) Ob die Bestrahlung vor oder nach der operativen Tumorentfernung besser ist
4) Ob eine zusätzliche Bestrahlung von Metastasen einen zusätzlichen Nutzen bringt.
5) Ob eine verlängerte Erhaltungschemotherapie besser ist
6) Neue Behandlungen bei Rückfall
Die Resultate der verschiedenen Behandlungspläne werden laufend analysiert. Im Verlauf der Studie können Behandlungspläne welchen weniger gut funktionieren, aus der Studie entfernt werden. Es können auch neue Behandlungspläne dazukommen.

Interventions (Source de données: WHO)

Product Name: Actinomycin DPharmaceutical Form: Lyophilisate for solution for injectionINN or Proposed INN: DACTINOMYCINCAS Number: 50-76-0Concentration unit: ?g microgram(s)Concentration type: equalConcentration number: 500-Product Name: DoxorubicinPharmaceutical Form: Solution for injection in vialINN or Proposed INN: DoxorubicinCAS Number: 23214-92-8Concentration unit: mg/ml milligram(s)/millilitreConcentration type: equalConcentration number: 2-Product Name: IfosfamidePharmaceutical Form: Powder for concentrate for solution for infusionINN or Proposed INN: IFOSFAMIDECAS Number: 3778-73-2Concentration unit: g gram(s)Concentration type: rangeConcentration number: 1-2Product Name: IrinotecanPharmaceutical Form: INN or Proposed INN: IRINOTECANCAS Number: 97682-44-5Concentration unit: mg/ml milligram(s)/millilitreConcentration type: equalConcentration number: 20-Product Name: VincristinePharmaceutical Form: Solution for injectionINN or Proposed INN: VINCRISTINECAS Number: 57-22-7Concentration unit: mg/ml milligram(s)/millilitreConcentration type: equalConcentration number: 1-Product Name: VinorelbinePharmaceutical Form: Concentrate for solution for infusionINN or Proposed INN: VINORELBINECAS Number: 71486-22-1Concentration unit: mg/ml milligram(s)/millilitreConcentration type: equalConcentration number: 10-Product Name: VinorelbinePharmaceutical Form: Capsule, softINN or Proposed INN: VINORELBINECAS Number: 71486-22-1Concentration unit: mg milligram(s)Concentration type: rangeConcentration number: 20-30Product Name: CyclophosphamidePharmaceutical Form: Powder for solution for injection/infusionINN or Proposed INN: CYCLOPHOSPHAMIDECAS Number: 50-18-0Concentration unit: mg milligram(s)Concentration type: rangeC

Critères de participation à l’étude (Source de données: BASEC)

- Histologisch bestätigtes RMS
- Unterschriebene Einwilligungserklärung
- Patienten stimmen zu während 6, Patientinnen stimmen zu während 12 Monaten zu verhüten

Critères d’exclusion (Source de données: BASEC)

- Vorgängige Stammzelltransplantation
- Sekundärtumor
- Schwangerschaft bei Patientinnen

Inclusion/Exclusion Criteria (Source de données: WHO)

Gender: Female: yesMale: yes
Inclusion criteria: Inclusion Criteria for study entry1. Histologically confirmed diagnosis of RMS (except pleomorphic RMS)2. Written informed consent from the patient and/or the parent/legal guardianInclusion criteria for all randomisations and registrations:? Patient agrees to use contraception during therapy and for 12 months after last trial treatment (females) or 6 months after last trial treatment (males), where patient is sexually active? Written informed consent from the patient and/or the parent/legal guardian? Medically fit to receive treatmentFrontline chemotherapy specific inclusion:? Entered in to the FaR-RMS study at diagnosis? No prior treatment for RMS other than surgery? Documented negative pregnancy test for female patients of childbearing potential? Adequate hepatic function: Total bilirubin = 1.5 times upper limit of normal (ULN) for age, unless the patient is known tohave Gilbert?s syndromePhase 1b Specific Inclusion? VHR disease? Age >12 months and =25 years? Adequate hepatic function: ALT or AST < 2.5 X ULN for age? Adequate renal function: estimated or measured creatinine clearance =60 ml/min/1.73 m2? Absolute neutrophil count =1.0x 10^9/L? Platelets = 80 x 10^9/LCT1a specific inclusion? VHR disease? Age = 6 months? Available for randomisation =60 days after diagnostic biopsy/surgery? Fractional Shortening = 28%? Absolute neutrophil count =1.0x 10^9/L (except in patients with documented bone marrow disease)? Platelets = 80 x 109/L (except in patients with documented bone marrow disease)CT1b specific inclusion? HR disease? Age = 6 months? Available for randomisation =60 days after diagnostic biopsy/surgery? Absolute neutrophil count =1.0x 10^9/L? Platelets = 80 x 10^9/LRadiotherapy Inclusion? Entered in to the FaR-RMS study (at diagnosis or prior to radiotherapy randomisation)? VHR, HR and SR disease? = 2 years of age? Receiving frontline induction treatment as part of the FaR-RMS trial or with a IVA/IVADo based chemotherapy regimen patients for whom. Note that patients for whom ifosfamide has been replaced with cyclophosphamide will be eligible? Documented negative pregnancy test for female patients of childbearing potentialRT1a and RT1b Specific Inclusion? Primary tumour deemed resectable (predicted R0/ R1 resection feasible) after 3 cycles of induction chemotherapy (6 cycles for metastatic disease)? Adjuvant radiotherapy required in addition to surgical resection (local decision).? Available for randomisation after cycle 3 and prior to the start of cycle 6 of induction chemotherapy for localised disease, or after cycle 6 and prior to the start of cycle 9 for metastatic diseaseRT1b and RT1c Specific Inclusion? Higher Local Failure Risk (HLFR) based on presence of either of the following criteria:o Unfavourable siteo Age = 18yrsRT1c Specific Inclusion? Primary radiotherapy indicated (local decision)? Available for randomisation after cycle 3 and prior to the start of cycle 6 of induction chemotherapy for localised disease, orafter cycle 6 and prior to the start of cycle 9 for metastatic diseaseRT2 Specific Inclusion? Available for randomisation after cycle 6 and before the start of cycle 9 of induction chemotherapy.? Unfavourable metastatic disease, defined as Modified Oberlin Prognostic Score 2-4Maintenance specific Inclusion? Received frontline induction chemotherapy as part of the FaR-RMS trial or with a IVA/IVADo based chemotherapy regimen. Patients for whom ifosfamide has be
Exclusion criteria: Phase 1b specific exclusion? Weight <10kg? Active > grade 2 diarrhoea? Prior allo- or autologous Stem Cell Transplant? Uncontrolled inter-current illness or active infection? Pre-existing medical condition precluding treatment? Known hypersensitivity to any of the treatments or excipients? Second malignancy? Pregnant or breastfeeding women? Urinary outflow obstruction that cannot be relieved prior to starting treatment? Active inflammation of the urinary bladder (cystitis)CT1a and CT1b specific exclusion? Active > grade 2 diarrhoea? Prior allo- or autologous Stem Cell Transplant? Uncontrolled inter-current illness or active infection? Pre-existing medical condition precluding treatment? Known hypersensitivity to any of the treatments or excipients? Second malignancy? Pregnant or breastfeeding women? Urinary outflow obstruction that cannot be relieved prior to starting treatment? Active inflammation of the urinary bladder (cystitis)Radiotherapy specific exclusion? Prior allo- or autologous Stem Cell Transplant? Second malignancy? Pregnant or breastfeeding women? Receiving radiotherapy as brachytherapyCT2a and CT2b specific Exclusion? Prior allo- or autologous Stem Cell Transplant? Uncontrolled inter current illness or active infection? Second malignancy? Pregnant or breastfeeding women? Urinary outflow obstruction that cannot be relieved prior to starting treatment? Active inflammation of the urinary bladder (cystitis)CT3 specific exclusion? Active > grade 2 diarrhoea? Prior allo- or autologous Stem Cell Transplant? Uncontrolled inter-current illness or active infection? Pre-existing medical condition precluding treatment? Known hypersensitivity to any of the treatments or excipients? Second malignancy? Pregnant or breastfeeding women

Plus de données sur l’étude tirée du registre primaire de l’OMS

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-000515-24

Plus de données sur l’étude tirée de la base de données de l’OMS (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2018-000515-24
Plus d’informations sur l’étude

Date d’enregistrement de l’étude

20 avr. 2022

Intégration du premier participant

10 juin 2022

Statut de recrutement

Authorised-recruitment may be ongoing or finished

Titre scientifique (Source de données: WHO)

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

Type d’étude (Source de données: WHO)

Interventional clinical trial of medicinal product

Conception de l’étude (Source de données: WHO)

Controlled: yesRandomised: yesOpen: yesSingle blind: noDouble blind: noParallel group: yesCross over: noOther: noIf controlled, specify comparator, Other Medicinial Product: yesPlacebo: noOther: yesOther specify the comparator: radiotherapy doseNumber of treatment arms in the trial: 19

Phase (Source de données: WHO)

Human pharmacology (Phase I): yesTherapeutic exploratory (Phase II): yesTherapeutic confirmatory - (Phase III): yesTherapeutic use (Phase IV): no

Points finaux primaires (Source de données: WHO)

Main Objective: Phase I Dose Finding StudiesThe aim is to determine the recommended phase II dose (RP2D) of new systemic therapy regimens.Frontline chemotherapy? To compare systemic therapy regimens for patients with Very High Risk (VHR) disease at diagnosis.?To compare new systemic therapy regimens with standard chemotherapy for patients with High Risk (HR) disease at diagnosis.Radiotherapy?To determine whether pre-operative or standard post-operative radiotherapy is better for patients with resectable disease (RT1A)?To determine whether dose escalation of radiotherapy improves the outcome in patients with a higher local failure risk (RT1B/C)?To determine whether radiotherapy treatment of all sites of disease, including metastatic sites, when compared to radiotherapy treatment to the primary site and involved regional lymph nodes alone, improves the outcome for patients with unfavourable metastatic disease (RT2);Secondary Objective: Secondary objectives:To validate whether the use of fusion status (PAX3/PAX7-FOXO1) in place of histopathological diagnosis improves risk stratification? To determine whether assessment of fusion status is necessary in tumours classified as Embryonal RMS (ERMS) by histopathology? To determine whether immunohistochemistry (IHC) assessment for protein expression driven by the fusion protein is an accurate surrogate for fusion status? To determine whether FDG PET- CT response assessment following induction chemotherapy is a prognostic biomarker for local failure and/ or survival.;Primary end point(s): The primary outcome measures for this study are as follows:Recommended Phase 2 Dose (RP2D) - Phase 1bEvent Free Survival for randomisations CT1a, CT1b, CT2, RT2 and CT3.Local failure free survival for randomisations RT1a, RT1b and RT1c;Timepoint(s) of evaluation of this end point: Event-free survival (EFS) time is defined as the time from the each relevant randomisation to first failure event.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 neoplasmLocal failure free survival (LFFS) time is defined as time from randomisation to first local failure event. A local failure event is relapse or progression of tumour at the primary site at any time even if there has been a prior concurrent local, regional ordistant failure.

Points finaux secondaires (Source de données: WHO)

Secondary end point(s): ? Best Response for randomisation CT3? Dose Limiting Toxicity for registration phase 1b? Event Free Survival for all patients, randomisations RT1a, RT1b, RT1c and also the PET sub-study? Local failure free survival for the PET sub-study? Loco-regional failure-free survival for randomisations RT1a, RT1b, RT1c and RT2? Health Related Quality of Life for randomisations RT1a and RT2? Maximum Tolerated Dose for registration phase 1b? Overall Survival for all patients, randomisations CT1a, CT1b, CT2, CT3, RT1a, RT1b, RT1c and also RT2? Response for registration phase 1b and also randomisations CT1a, CT1b, and CT3? Recommended Phase II Dose for registration phase 1b? Toxicity for registration phase 1b and also randomisations CT1a, CT1b, and CT3? Duration of response for randomisation CT3? Acute post-radiotherapy complications for randomisations RT1a, RT1b, RT1c and RT2? Late complications for randomisations RT1a, RT1b and RT1c? Acute post-operative complications for randomisations RT1a and RT1b? Wound complications for randomisations RT1a and RT1b? PET response for the PET sub-study;Timepoint(s) of evaluation of this end point: ? first failure event? death from any cause? first local failure event? first local or regional failure event.? 30 days after the last treatment? within 120 days from surgery? completion of radiotherapy? Progression? Relapse? after 120 days from last local therapy.? at the start of radiotherapy,? At completion of radiotherapy,? 3 months following the end of radiotherapy,? 24 months following radiotherapy? after course 2 and 6 for the newly diagnosed chemotherapy? after course 2 and 4 for the relapse randomisation.? End of any Phase 1b study? time point at which no or one participant experiences a DLT when at least two of three to six participants experience a DLT atthe next highest dose? 3 cycles of induction chemotherapy

Contact pour informations (Source de données: WHO)

Cancer Research UK;Gustave Roussy

Résultats de l’étude (Source de données: WHO)

Résumé des résultats

pas encore d’informations disponibles

Lien vers les résultats dans le registre primaire

pas encore d’informations disponibles

Informations sur la disponibilité des données individuelles des participants

pas encore d’informations disponibles

Lieux de réalisation des études

Lieux de réalisation des études en Suisse (Source de données: BASEC)

Aarau, Bâle, Bellinzona, Berne, Genève, Lausanne, Luzern, St-Gall, Zurich

Pays où sont réalisées les études (Source de données: WHO)

Australia, Austria, Belgium, Canada, Croatia, Czech Republic, Czechia, Denmark, Finland, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom

Contact pour plus d’informations sur l’étude

Données sur la personne de contact en Suisse (Source de données: BASEC)

Dr. med. Willemijn Breunis
+41 44 266 74 55
willemijn.breunis@kispi.uzh.ch

Contact pour des informations générales (Source de données: WHO)

Louise Moeller
University of Birmingham, Edgbaston
University of Birmingham
0044121414 29 96
farrms@trials.bham.ac.uk

Contact pour des informations scientifiques (Source de données: WHO)

Louise Moeller
University of Birmingham, Edgbaston
University of Birmingham
0044121414 29 96
farrms@trials.bham.ac.uk

Autorisation de la commission d’éthique (Source de données: BASEC)

Nom de la commission d’éthique chargée de l’autorisation (dans le cas d’études multicentriques, uniquement la commission directrice)

Kantonale Ethikkommission Zürich

Date d’autorisation de la commission d’éthique

24.08.2021

Plus de numéros d’identification d’étude

Numéro d’identification de l’étude de la commission d’éthique (BASEC-ID) (Source de données: BASEC)

2021-01257

Secondary ID (Source de données: WHO)

ISRCTN45535982
NCT04625907
RG_17-247
2018-000515-24-IE
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