Spots Global Cancer Trial Database for A Study of Avastin (Bevacizumab) in Combination With Standard Chemotherapy in Children and Adolescents With Sarcoma.
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Trial Identification
Brief Title: A Study of Avastin (Bevacizumab) in Combination With Standard Chemotherapy in Children and Adolescents With Sarcoma.
Official Title: An Open-label, Multi-center, Randomized Study of the Safety and Effect on Event-free Survival of Bevacizumab in Combination With Standard Chemotherapy in Childhood and Adolescent Patients With Metastatic Rhabdomyosarcoma and Non-rhabdomyosarcoma Soft Tissue Sarcoma
Study ID: NCT00643565
Conditions
Study Description
Brief Summary: This open-label two-arm study will assess the safety and efficacy of a combination of bevacizumab + standard chemotherapy with standard chemotherapy alone as active comparator in childhood and adolescent patients with metastatic rhabdomyosarcoma or non-rhabdomyosarcoma soft tissue sarcoma. Patients will be randomized to receive bevacizumab + standard chemotherapy or standard chemotherapy alone. Treatment will consist of 9 x 3-week cycles of induction treatment (standard chemotherapy with or without bevacizumab 7.5 mg/kg iv on day 1 of each cycle) followed by 12 x 4-week cycles of maintenance treatment (standard chemotherapy with or without bevacizumab 5 mg/kg iv on days 1 and 15 of each cycle). The anticipated time on study treatment is 1-2 years.
Detailed Description:
Keywords
Eligibility
Minimum Age: 6 Months
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Hôpital Enfants Reine Fabiola, Bruxelles, , Belgium
Cliniques Universitaires St-Luc, Bruxelles, , Belgium
UZ Gent, Gent, , Belgium
Instituto Nacional do Cancer - INCA, Rio de Janeiro, RJ, Brazil
Clinica de Oncologia de Porto Alegre - CliniOnco, Porto Alegre, RS, Brazil
Hospital de Cancer de Barretos, Barretos, SP, Brazil
Instituto de Oncologia Pediatrica, Sao Paulo, SP, Brazil
ITACI - Instituto de Tratamento do Cancer Infantil, Sao Paulo, SP, Brazil
Hospital Santa Marcelina, Sao Paulo, SP, Brazil
Hospital For Sick Children, Toronto, Ontario, Canada
Pavillion Chul-Chuq, Sainte-foy, Quebec, Canada
Hospital Luis Calvo Mackenna; Oncologia, Santiago, , Chile
Fakultni nemocnice Brno, Brno, , Czechia
Fakultni nemocnice v Motole, Praha 5, , Czechia
CHU Bordeaux; Unite Onco-Hematologie Pediatrique, Bordeaux, , France
Centre Oscar Lambret; Service de Pediatrie, Lille, , France
Centre Leon Berard; Pediatrie, Lyon, , France
Hopital Timone Enfants; Onco Pediatrie, Marseille, , France
Chr De Nantes; Service D'oncologie Pediatrique, Nantes, , France
Institut Curie; Oncologie Medicale, Paris, , France
CHU Hopital Sud; Service d'Hematologie Pediatrique, Rennes, , France
Hopital Des Enfants; Service d Hemato-Oncologie, Toulouse, , France
CHU Hopital d Enfants; Centre hospitalier Universitaire Nancy, Vandoeuvre Les Nancy, , France
Institut Gustave Roussy; Service Pediatrique, Villejuif, , France
University Hospital Essen; Department of Pediatric Oncology, Essen, , Germany
Universitaetsklinikum Freiburg - PS; Partnersite - Onkologie, Freiburg, , Germany
Universitatsklinikum Munster; Padiatrische Hamatologie und Onkologie, Münster, , Germany
Soroka Medical Center, Beer Sheva, , Israel
Rambam Health Care Campus; Pediatric Hematology Oncology Department, Haifa, , Israel
Schneider Children's Medical Center, Petach-Tikva, , Israel
Tel Aviv Sourasky MC, Dana Children's Hospital; Pediatric Hemato-Oncology Clinic, Tel Aviv, , Israel
Ospedale Pediatrico Bambino Gesu, Roma, Lazio, Italy
Istituto Gaslini Ospedale Pediatrico; Dipartimento di Oncoematologia pediatrica, Genova, Liguria, Italy
Istituto Nazionale Tumori di Milano; S.C. Oncologia Pediatrica, Milano, Lombardia, Italy
Dipartimento di Scienze Pediatriche Adolescenza; Osp. Infantile Regina Margherita, Torino, Piemonte, Italy
U.O.A University Onco-Ematologia Pedicatria; Azienda Ospedaliera A.Meyer, Firenze, Toscana, Italy
Azienda Ospedaliera di Padova; Clinica di Onco-ematologia pediatrica, Padova, Veneto, Italy
Emma Kinderziekenhuis; Dept of Pediatric Oncology, Amsterdam, , Netherlands
Erasmus Mc/Sophia's Childrens Hospital; Dept. of Pediatric Oncology, Rotterdam, , Netherlands
Prinses Maxima Centrum, Utrecht, , Netherlands
Uniwersytet Medyczny W Lublinie; Klinika Hematologii i Onkologii Dzieciecej, Lublin, , Poland
Instytut Pomnik-Centrum Zdrowia Dziecka; Klinika Onkologii, Warsaw, , Poland
Center for Children's Hematology, Oncology and Immunology, Moscow, , Russian Federation
Saint-Petersburg SHI City Clinical Hospital #31, St. Petersburg, , Russian Federation
Hospital de Cruces, Barakaldo, Vizcaya, Spain
Hospital Universitari Vall d'Hebron; Servicio de Nefrologia, Barcelona, , Spain
Hospital Infantil Universitario Nino Jesus, Madrid, , Spain
Hospital Regional Universitario Carlos Haya;Servicio Oncologia Pediatrica, Malaga, , Spain
Hospital Universitario Virgen del Rocio; Servicio de Onco-Hematologia Pediatrica, Sevilla, , Spain
Hospital Universitario La Fe, Valencia, , Spain
Birmingham Childrens Hospital; Oncology Dept, Birmingham, , United Kingdom
Bristol Royal Hospital For Children, Bristol, , United Kingdom
Royal Hospital for Sick Children, Edinburgh, , United Kingdom
Royal Hospital For Children, Glasgow, , United Kingdom
St. James's University Hospital; Leeds Regional Paediatric Oncology Unit, Leeds, , United Kingdom
Alder Hey Children s Hospital; Department of Pediatrics, Liverpool, , United Kingdom
Great Ormond Street Hospital; Dept. Of Pediatric Oncology, London, , United Kingdom
Royal Manchester Children's Hospital, Manchester, , United Kingdom
The Royal Victoria Infirmary; Paediatric and Adolescent Oncology Unit, Newcastle Upon Tyne, , United Kingdom
University Hospital Queens Medical Centre; Department of Paediatric Oncology, Nottingham, , United Kingdom
Royal Marsden Hospital; Pediatric Unit, Surrey, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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