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Spots Global Cancer Trial Database for FaR-RMS: An Overarching Study for Children and Adults With Frontline and Relapsed RhabdoMyoSarcoma

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Trial Identification

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

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

Study ID: NCT04625907

Study Description

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

Detailed Description: FaR-RMS is an over-arching study for children and adults with newly diagnosed and relapsed rhabdomyosarcoma (RMS). It is a multi-arm, multi-stage format, involving several different trial questions. FaR-RMS is intended to be a rolling programme of research with new treatment arms being introduced dependant on emerging data and innovation. 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.

Keywords

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Queensland Children's Hospital, Brisbane, , Australia

Chris O'brien Lifehouse, Camperdown, , Australia

Monash Children's Hospital, Clayton, , Australia

Peter Maccallum Cancer Centre, Melbourne, , Australia

Royal Childrens Hospital Melbourne, Melbourne, , Australia

John Hunter Children's Hospital, New Lambton Heights, , Australia

Perth Children's Hospital, Perth, , Australia

Sydney Children's Hospital, Sydney, , Australia

The Childrens Hospital At Westmead, Sydney, , Australia

Westmead Hospital, Westmead, , Australia

Princess Alexandra Hospital, Woolloongabba, , Australia

Kepler University Clinic Linz, Linz, , Austria

St Anna Childrens Hospital, Vienna, , Austria

Hopital Universitaire Des Enfants Reine Fabiola, Brussels, , Belgium

Cliniques Universitaires Saint Luc, Bruxelles, , Belgium

Universitair Ziekenhuis Gent, Gent, , Belgium

Uz Leuven Campus Gasthuisberg, Leuven, , Belgium

Centre Hospitalier Regional De La Citadelle, Liège, , Belgium

Clinique Chc Montlegia, Liège, , Belgium

Masaryk University Hospital Brno, Brno, , Czechia

Aarhus University Hospital, Aarhus, , Denmark

University Hospital Rigshospitalet, Copenhagen, , Denmark

Centre Hospitalier Universitaire D'angers, Angers, , France

Centre Hospitalier Regional Universitaire Besancon - Hopital Jean Minjoz, Besançon, , France

Centre Hospitalier Universitaire De Bordeaux - Hopital Pellegrin, Bordeaux, , France

Centre Hospitalier Regional Universitaire Brest - Hopital Morvan, Brest, , France

Centre Francois Baclesse, Caen, , France

Centre Hospitalier Universitaire De Caen, Caen, , France

Centre Hospitalier Universitaire Dijon Bourgogne - Hopital D'enfants, Dijon, , France

Centre Hospitalier Universitaire De Grenoble, Grenoble, , France

Centre Hospitalier Universitaire La Reunion, La Réunion, , France

Centre Oscar Lambret, Lille, , France

Centre Leon Berard, Lyon, , France

Hopital De La Timone (ap-hm), Marseille, , France

Centre Hospitalier Universitaire De Nancy, Nancy, , France

Centre Hospitalier Universitaire De Nantes, Nantes, , France

Hopital Armand Trousseau, Paris, , France

Institut Curie, Paris, , France

Centre Hospitalier Universitaire Haut Levque, Pessac, , France

Centre Hospitalier Universitaire De Poitiers, Poitiers, , France

Chu De Reims, Reims, , France

Centre Eugne Marquis De Rennes, Rennes, , France

Centre Hospitalier Universitaire De Rennes - Hopital Pontchaillou, Rennes, , France

Centre Hospitalier Universitaire De Rouen, Rouen, , France

Centre Hospitalier Universitaire Saint-etienne, Saint-Étienne, , France

Strasbourg Hautepierre, Strasbourg, , France

Centre Hospitalier Universitaire De Toulouse - Hopital Des Enfants, Toulouse, , France

Centre Hospitalier Regional Universitaire De Tours - Hopital Clocheville, Tours, , France

Gustave Roussy, Villejuif, , France

Children's General Hospital P and A Kyriakou, Athens, , Greece

Department of Pediatric Hematology-oncology - Aghia Sophia Children's Hospital, Athens, , Greece

Hellenic Society of Pediatric Hematology- Oncology, Athens, , Greece

University Unit of Pediatric Oncology-hematology - Children's Hospital Agia Sophia, Athens, , Greece

Children's and Adolescent's Oncology Clinic, "MITERA" Children's Hospital, Attikí, , Greece

Hematology-oncology Children's Clinic, University General Hospital of Heraklion, Iraklio, , Greece

Ippokratio General Hospital of Thessaloniki, Thessaloniki, , Greece

Ahepa University General Hospital of Thessaloniki, Thessaloníki, , Greece

Our Lady's Children's Hospital, Crumlin, , Ireland

Rambam Health Care Campus, Haifa, , Israel

Hadassah University Medical Centre, Jerusalem, , Israel

Schneider Medical Centre, Petah Tikva, , Israel

Dana Children's Hospital, Tel Aviv Sourasky Medical Center, Tel Aviv, , Israel

Chaim Sheba Medical Centre, Tel HaShomer, , Israel

University Hospital of Padova (azienda Ospedaliera of Padua), Padova, , Italy

University Medical Centre Groningen, Groningen, , Netherlands

Prinses Maxima Centrum Voor Kinderoncologie, Utrecht, , Netherlands

Starship Children's Health, Auckland, , New Zealand

Christchurch Hospital, Christchurch, , New Zealand

Haukeland University Hospital - Paediatric, Bergen, , Norway

Oslo University Hospital - Paediatrics, Oslo, , Norway

Oslo University Hospital - Radiumhospitalet, Oslo, , Norway

University Hospital of North Norway - Paediatric, Tromso, , Norway

St Olavs Hospital - Paediatric, Trondheim, , Norway

Instituto Portugues De Oncologia De Losbona Francisco Gentil, Epe, Lisbon, , Portugal

Bratislava, National Institute for Children's Diseases, Bratislava, , Slovakia

University Childrens Hospital Ljubljana, Ljubljana, , Slovenia

University Medical Centre Ljubjlana, Ljubljana, , Slovenia

Hospital Sant Joan De Deu, Barcelona, , Spain

Hospital Universitari Vall D'hebron, Barcelona, , Spain

Hospital De Cruces, Bilbao, , Spain

Hospital Del Nino Jesus, Madrid, , Spain

Hospital Universitario Gregorio Maranon, Madrid, , Spain

Hospital Universitario La Paz, Madrid, , Spain

Hospital Regional Universitario De Malaga, Malaga, , Spain

Hospital Virgen Del Rocio, Seville, , Spain

Hospital Politecnico U La Fe, Valencia, , Spain

Hospital Universitario Miguel Servet Materno - infantil, Zaragoza, , Spain

Uppsala University Childrens Hospital, Uppsala, , Sweden

Kantonsspital Aarau, Aarau, , Switzerland

Universitats-kinderspital Bieder Basel (UKBB), Basel, , Switzerland

Ospedale San Giovanni, Bellinzona, , Switzerland

Inselspital Bern, Bern, , Switzerland

Hug Hopitaux Universitaires De Geneve, Geneva, , Switzerland

Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Lausanne, , Switzerland

Luzerner Kantonspital - Kinderspital Luzern, Luzern, , Switzerland

Ostschweizer Kinderspital, St Gallen, , Switzerland

Universitaetsspital Zurich, Zurich, , Switzerland

Royal Marsden Hospital, Sutton, Surrey, United Kingdom

Royal Aberdeen Children's Hospital, Aberdeen, , United Kingdom

Belfast City Hospital, Belfast, , United Kingdom

Royal Belfast Hospital for Sick Children, Belfast, , United Kingdom

Birmingham Children's Hospital, Birmingham, , United Kingdom

The Queen Elizabeth Hospital, Birmingham, , United Kingdom

Bristol Haematology And Oncology Centre, Bristol, , United Kingdom

Bristol Royal Hospital for Children, Bristol, , United Kingdom

Addenbrooke's Hospital, Cambridge, , United Kingdom

Noah's Ark Children's Hospital for Wales, Cardiff, , United Kingdom

Velindre Hospital, Cardiff, , United Kingdom

Royal Hospital for Children and Young People, Edinburgh, , United Kingdom

Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom

Royal Hospital for Children Glasgow, Glasgow, , United Kingdom

Leeds General Infirmary, Leeds, , United Kingdom

St James's University Hospital, Leeds, , United Kingdom

Leicester Royal Infirmary, Leicester, , United Kingdom

Alder Hey Children's Hospital, Liverpool, , United Kingdom

Great Ormond Street Hospital for Children, London, , United Kingdom

Royal Marsden Hospital London, London, , United Kingdom

University College London Hospital, London, , United Kingdom

Royal Manchester Children's Hospital, Manchester, , United Kingdom

Christie Hospital, Manchester, , United Kingdom

Royal Victoria Infirmary, Newcastle Upon Tyne, , United Kingdom

Nottingham City Hospital, Nottingham, , United Kingdom

Queen's Medical Centre, Nottingham, Nottingham, , United Kingdom

John Radcliffe Hospital, Oxford, , United Kingdom

Sheffield Children's Hospital, Sheffield, , United Kingdom

Weston Park Hospital, Sheffield, , United Kingdom

Southampton General Hospital, Southampton, , United Kingdom

Clatterbridge Cancer Centre, Wirral, , United Kingdom

Contact Details

Name: Meriel Jenney

Affiliation: Chief Investigator

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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