Actively Recruiting
FaR-RMS: An Overarching Study for Children and Adults With Frontline and Relapsed RhabdoMyoSarcoma
Led by University of Birmingham · Updated on 2024-05-23
1672
Participants Needed
128
Research Sites
506 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
FaR-RMS is an over-arching study for children and adults with newly diagnosed and relapsed rhabdomyosarcoma (RMS)
CONDITIONS
Official Title
FaR-RMS: An Overarching Study for Children and Adults With Frontline and Relapsed RhabdoMyoSarcoma
Who Can Participate
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
- Age >12 months and 4 years for Phase 1b dose finding
- Very High Risk disease for Phase 1b dose finding
- No prior treatment for RMS other than surgery for Phase 1b dose finding
- Medically fit to receive treatment for Phase 1b dose finding
- Adequate liver function: total bilirubin 4 1.5 times upper limit of normal (ULN) for age unless Gilbert's syndrome, ALT or AST < 2.5 x ULN
- Absolute neutrophil count 4 1.0 x 10^9/L
- Platelets 4 80 x 10^9/L
- Adequate kidney function: creatinine clearance 4 60 ml/min/1.73 m2
- Negative pregnancy test for females of childbearing potential
- Agreement to use contraception during therapy and for 12 months after last trial treatment (females) or 6 months (males) if sexually active
- Entered into FaR-RMS study at diagnosis or prior to radiotherapy depending on randomisation group
- Age 4 6 months for frontline chemotherapy randomisations
- Available for randomisation within 60 days after diagnostic biopsy or surgery
- Fractional shortening 4 28% for frontline chemotherapy randomisations
- For radiotherapy randomisations, age 4 2 years and receiving frontline induction treatment
- Completion of required cycles of maintenance chemotherapy without disease progression or severe vincristine neuropathy for maintenance chemotherapy randomisations
- Measurable or evaluable disease for relapsed chemotherapy randomisation
- Medically fit to receive trial treatment for all groups
- Written informed consent from patient or guardian
You will not qualify if you...
- Weight less than 10 kg
- Active grade >2 diarrhea
- Prior allogeneic or autologous stem cell transplant
- Uncontrolled inter-current illness or active infection
- Pre-existing medical condition that prevents treatment
- Urinary outflow obstruction that cannot be relieved before treatment
- Active bladder inflammation (cystitis)
- Known allergy to any study treatments or ingredients
- Second malignancy
- Pregnant or breastfeeding women
- Progression during frontline therapy without prior response for relapsed chemotherapy
- Prior treatment with regorafenib or temozolomide for relapsed chemotherapy
- Elevated liver enzymes above specified limits for relapsed chemotherapy
- Certain cardiac conditions including unstable angina or heart failure
- Uncontrolled high blood pressure above 95th percentile for age and gender
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 128 locations
1
Queensland Children's Hospital
Brisbane, Australia, 4101
Actively Recruiting
2
Chris O'brien Lifehouse
Camperdown, Australia
Actively Recruiting
3
Monash Children's Hospital
Clayton, Australia
Actively Recruiting
4
Peter Maccallum Cancer Centre
Melbourne, Australia
Actively Recruiting
5
Royal Childrens Hospital Melbourne
Melbourne, Australia
Actively Recruiting
6
John Hunter Children's Hospital
New Lambton Heights, Australia, 2310
Actively Recruiting
7
Perth Children's Hospital
Perth, Australia
Actively Recruiting
8
Sydney Children's Hospital
Sydney, Australia
Actively Recruiting
9
The Childrens Hospital At Westmead
Sydney, Australia
Actively Recruiting
10
Westmead Hospital
Westmead, Australia
Actively Recruiting
11
Princess Alexandra Hospital
Woolloongabba, Australia
Actively Recruiting
12
Kepler University Clinic Linz
Linz, Austria
Actively Recruiting
13
St Anna Childrens Hospital
Vienna, Austria
Actively Recruiting
14
Cliniques Universitaires Saint Luc
Brussels, Belgium
Actively Recruiting
15
Hopital Universitaire Des Enfants Reine Fabiola
Brussels, Belgium
Actively Recruiting
16
Universitair Ziekenhuis Gent
Ghent, Belgium
Actively Recruiting
17
Uz Leuven Campus Gasthuisberg
Leuven, Belgium
Actively Recruiting
18
Centre Hospitalier Regional De La Citadelle
Liège, Belgium
Actively Recruiting
19
Clinique Chc Montlegia
Liège, Belgium
Actively Recruiting
20
Masaryk University Hospital Brno
Brno, Czechia, 625 00
Actively Recruiting
21
Aarhus University Hospital
Aarhus, Denmark
Actively Recruiting
22
University Hospital Rigshospitalet
Copenhagen, Denmark
Actively Recruiting
23
Centre Hospitalier Universitaire D'angers
Angers, France
Actively Recruiting
24
Centre Hospitalier Regional Universitaire Besancon - Hopital Jean Minjoz
Besançon, France
Actively Recruiting
25
Centre Hospitalier Universitaire De Bordeaux - Hopital Pellegrin
Bordeaux, France
Actively Recruiting
26
Centre Hospitalier Regional Universitaire Brest - Hopital Morvan
Brest, France
Actively Recruiting
27
Centre Francois Baclesse
Caen, France
Actively Recruiting
28
Centre Hospitalier Universitaire De Caen
Caen, France
Actively Recruiting
29
Centre Hospitalier Universitaire Dijon Bourgogne - Hopital D'enfants
Dijon, France
Actively Recruiting
30
Centre Hospitalier Universitaire De Grenoble
Grenoble, France
Actively Recruiting
31
Centre Hospitalier Universitaire La Reunion
La Réunion, France
Actively Recruiting
32
Centre Oscar Lambret
Lille, France
Actively Recruiting
33
Centre Leon Berard
Lyon, France
Actively Recruiting
34
Hopital De La Timone (ap-hm)
Marseille, France
Actively Recruiting
35
Centre Hospitalier Universitaire De Nancy
Nancy, France
Actively Recruiting
36
Centre Hospitalier Universitaire De Nantes
Nantes, France
Actively Recruiting
37
Hopital Armand Trousseau
Paris, France
Actively Recruiting
38
Institut Curie
Paris, France
Actively Recruiting
39
Centre Hospitalier Universitaire Haut Levque
Pessac, France
Actively Recruiting
40
Centre Hospitalier Universitaire De Poitiers
Poitiers, France
Actively Recruiting
41
Chu De Reims
Reims, France
Actively Recruiting
42
Centre Eugne Marquis De Rennes
Rennes, France
Actively Recruiting
43
Centre Hospitalier Universitaire De Rennes - Hopital Pontchaillou
Rennes, France
Actively Recruiting
44
Centre Hospitalier Universitaire De Rouen
Rouen, France
Actively Recruiting
45
Centre Hospitalier Universitaire Saint-etienne
Saint-Etienne, France
Actively Recruiting
46
Strasbourg Hautepierre
Strasbourg, France
Actively Recruiting
47
Centre Hospitalier Universitaire De Toulouse - Hopital Des Enfants
Toulouse, France
Actively Recruiting
48
Centre Hospitalier Regional Universitaire De Tours - Hopital Clocheville
Tours, France
Actively Recruiting
49
Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
50
Children's General Hospital P and A Kyriakou
Athens, Greece, 115 27
Actively Recruiting
51
Department of Pediatric Hematology-oncology - Aghia Sophia Children's Hospital
Athens, Greece
Actively Recruiting
52
Hellenic Society of Pediatric Hematology- Oncology
Athens, Greece
Actively Recruiting
53
University Unit of Pediatric Oncology-hematology - Children's Hospital Agia Sophia
Athens, Greece
Actively Recruiting
54
Children's and Adolescent's Oncology Clinic, "MITERA" Children's Hospital
Attiki, Greece, 151 23
Actively Recruiting
55
Hematology-oncology Children's Clinic, University General Hospital of Heraklion
Heraklion, Greece, 715 00
Actively Recruiting
56
Ahepa University General Hospital of Thessaloniki
Thessaloniki, Greece
Actively Recruiting
57
Ippokratio General Hospital of Thessaloniki
Thessaloniki, Greece
Actively Recruiting
58
Our Lady's Children's Hospital
Crumlin, Ireland
Not Yet Recruiting
59
Rambam Health Care Campus
Haifa, Israel
Actively Recruiting
60
Hadassah University Medical Centre
Jerusalem, Israel
Actively Recruiting
61
Schneider Medical Centre
Petah Tikva, Israel
Actively Recruiting
62
Dana Children's Hospital, Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Actively Recruiting
63
Chaim Sheba Medical Centre
Tel Litwinsky, Israel
Actively Recruiting
64
University Hospital of Padova (azienda Ospedaliera of Padua)
Padova, Italy
Not Yet Recruiting
65
University Medical Centre Groningen
Groningen, Netherlands
Actively Recruiting
66
Prinses Maxima Centrum Voor Kinderoncologie
Utrecht, Netherlands
Actively Recruiting
67
Starship Children's Health
Auckland, New Zealand
Actively Recruiting
68
Christchurch Hospital
Christchurch, New Zealand
Actively Recruiting
69
Haukeland University Hospital - Paediatric
Bergen, Norway
Actively Recruiting
70
Oslo University Hospital - Paediatrics
Oslo, Norway
Actively Recruiting
71
Oslo University Hospital - Radiumhospitalet
Oslo, Norway
Actively Recruiting
72
University Hospital of North Norway - Paediatric
Tromsø, Norway
Actively Recruiting
73
St Olavs Hospital - Paediatric
Trondheim, Norway
Actively Recruiting
74
Instituto Portugues De Oncologia De Losbona Francisco Gentil, Epe
Lisbon, Portugal
Not Yet Recruiting
75
Bratislava, National Institute for Children's Diseases
Bratislava, Slovakia
Not Yet Recruiting
76
University Childrens Hospital Ljubljana
Ljubljana, Slovenia
Actively Recruiting
77
University Medical Centre Ljubjlana
Ljubljana, Slovenia
Actively Recruiting
78
Hospital Sant Joan De Deu
Barcelona, Spain
Actively Recruiting
79
Hospital Universitari Vall D'hebron
Barcelona, Spain
Actively Recruiting
80
Hospital De Cruces
Bilbao, Spain, 48903
Actively Recruiting
81
Hospital Del Nino Jesus
Madrid, Spain, 28009
Actively Recruiting
82
Hospital Universitario Gregorio Maranon
Madrid, Spain, 28009
Actively Recruiting
83
Hospital Universitario La Paz
Madrid, Spain
Actively Recruiting
84
Hospital Regional Universitario De Malaga
Málaga, Spain
Actively Recruiting
85
Hospital Virgen Del Rocio
Seville, Spain
Actively Recruiting
86
Hospital Politecnico U La Fe
Valencia, Spain, 46026
Actively Recruiting
87
Hospital Universitario Miguel Servet Materno - infantil
Zaragoza, Spain
Actively Recruiting
88
Uppsala University Childrens Hospital
Uppsala, Sweden
Actively Recruiting
89
Kantonsspital Aarau
Aarau, Switzerland
Actively Recruiting
90
Universitats-kinderspital Bieder Basel (UKBB)
Basel, Switzerland
Actively Recruiting
91
Ospedale San Giovanni
Bellinzona, Switzerland
Actively Recruiting
92
Inselspital Bern
Bern, Switzerland
Actively Recruiting
93
Hug Hopitaux Universitaires De Geneve
Geneva, Switzerland
Actively Recruiting
94
Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne
Lausanne, Switzerland
Actively Recruiting
95
Luzerner Kantonspital - Kinderspital Luzern
Lucerne, Switzerland
Actively Recruiting
96
Ostschweizer Kinderspital
Sankt Gallen, Switzerland
Actively Recruiting
97
Universitaetsspital Zurich
Zurich, Switzerland
Actively Recruiting
98
Royal Marsden Hospital
Sutton, Surrey, United Kingdom, SM2 5PT
Actively Recruiting
99
Royal Aberdeen Children's Hospital
Aberdeen, United Kingdom
Actively Recruiting
100
Belfast City Hospital
Belfast, United Kingdom
Not Yet Recruiting
101
Royal Belfast Hospital for Sick Children
Belfast, United Kingdom
Not Yet Recruiting
102
Birmingham Children's Hospital
Birmingham, United Kingdom
Actively Recruiting
103
The Queen Elizabeth Hospital
Birmingham, United Kingdom
Not Yet Recruiting
104
Bristol Haematology And Oncology Centre
Bristol, United Kingdom
Actively Recruiting
105
Bristol Royal Hospital for Children
Bristol, United Kingdom
Actively Recruiting
106
Addenbrooke's Hospital
Cambridge, United Kingdom
Actively Recruiting
107
Noah's Ark Children's Hospital for Wales
Cardiff, United Kingdom
Actively Recruiting
108
Velindre Hospital
Cardiff, United Kingdom
Actively Recruiting
109
Royal Hospital for Children and Young People
Edinburgh, United Kingdom
Actively Recruiting
110
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
Actively Recruiting
111
Royal Hospital for Children Glasgow
Glasgow, United Kingdom
Actively Recruiting
112
Leeds General Infirmary
Leeds, United Kingdom
Actively Recruiting
113
St James's University Hospital
Leeds, United Kingdom
Actively Recruiting
114
Leicester Royal Infirmary
Leicester, United Kingdom
Actively Recruiting
115
Alder Hey Children's Hospital
Liverpool, United Kingdom
Actively Recruiting
116
Great Ormond Street Hospital for Children
London, United Kingdom
Actively Recruiting
117
Royal Marsden Hospital London
London, United Kingdom
Actively Recruiting
118
University College London Hospital
London, United Kingdom
Actively Recruiting
119
Royal Manchester Children's Hospital
Manchester, United Kingdom, M13 9WL
Actively Recruiting
120
Christie Hospital
Manchester, United Kingdom
Actively Recruiting
121
Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, United Kingdom
Actively Recruiting
122
Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom
Actively Recruiting
123
Nottingham City Hospital
Nottingham, United Kingdom
Actively Recruiting
124
Queen's Medical Centre, Nottingham
Nottingham, United Kingdom
Actively Recruiting
125
John Radcliffe Hospital
Oxford, United Kingdom
Actively Recruiting
126
Sheffield Children's Hospital
Sheffield, United Kingdom
Actively Recruiting
127
Weston Park Hospital
Sheffield, United Kingdom
Not Yet Recruiting
128
Southampton General Hospital
Southampton, United Kingdom
Actively Recruiting
Research Team
B
Bridget Shaw
CONTACT
E
Emma Gray
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
19
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