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Brief Title: A Study to Compare the Efficacy and Safety of Ifosfamide and Etoposide With or Without Lenvatinib in Children, Adolescents and Young Adults With Relapsed and Refractory Osteosarcoma
Official Title: A Multicenter, Open-label, Randomized Phase 2 Study to Compare the Efficacy and Safety of Lenvatinib in Combination With Ifosfamide and Etoposide Versus Ifosfamide and Etoposide in Children, Adolescents and Young Adults With Relapsed or Refractory Osteosarcoma (OLIE)
Study ID: NCT04154189
Brief Summary: This Is a Multicenter, Randomized, Open-Label, Parallel-Group, Phase 2 Study to Compare the Efficacy and Safety of Lenvatinib in Combination with Ifosfamide and Etoposide Versus Ifosfamide and Etoposide in Children, Adolescents, and Young Adults with Relapsed or Refractory Osteosarcoma.
Detailed Description:
Minimum Age: 2 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Children's of Alabama, Birmingham, Alabama, United States
Loma Linda University Medical Center, Loma Linda, California, United States
Children's Hospital of Orange County, Orange, California, United States
UCSF Benioff Children's Hospitals, San Francisco, California, United States
Childrens Hospital Colorado, Aurora, Colorado, United States
Children's National Medical Center, Washington, District of Columbia, United States
Riley Hospital For Children, Indianapolis, Indiana, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
Children's Medical Center Dallas, Dallas, Texas, United States
Cook Children's Health Care System, Fort Worth, Texas, United States
Texas Children's Hospital, Houston, Texas, United States
Chris O'Brien Lifehouse Hospital, Camperdown, , Australia
Perth Childrens Hospital, Nedlands, , Australia
Royal Children's Hospital Melbourne, Parkville, , Australia
Queensland Children's Hospital, South Brisbane, , Australia
Children's Hospital at Westmead, Westmead, , Australia
St. Anna Kinderspital, Wien, , Austria
UZ Gent, Gent, , Belgium
Hospital For Sick Children, Toronto, , Canada
FN Brno 2 Detska Klinika, Brno, , Czechia
Fakultní nemocnice v Motole, Prague, , Czechia
Tampereen yliopistollinen sairaala, Tampere, Länsi-Suomen Lääni, Finland
Centre Hospitalier Universitaire de Bordeaux, Hopital Pellegrin, Bordeaux, , France
Centre Oscar Lambret, Lille, , France
Centre Léon Berard, Lyon, , France
Hopitaux de La Timone, Marseille, , France
Hôpital de La Mère Et de L'enfant, Nantes, , France
CHU de Nice, Nice, , France
Hôpital Armand Trousseau, Paris, , France
Institut Curie, Paris, , France
Hopital de Hautepierre, Strasbourg, , France
Hôpital Des Enfants, Toulouse, , France
CHRU Nancy, Vandœuvre-lès-Nancy, , France
Institut Gustave Roussy, Villejuif, , France
Hong Kong Children's Hospital, Hong Kong, , Hong Kong
Prince of Wales Hospital, Hong Kong, , Hong Kong
Children's Health Ireland at Crumlin, Dublin, , Ireland
Schneider Children's Medical Center of Israel, Petach Tikva, , Israel
Istituti Ortopedici Rizzoli, Bologna, , Italy
Azienda Ospedaliera A Meyer, Firenze, , Italy
Istituto Giannina Gaslini, Genova, , Italy
Istituto Nazionale Dei Tumori, Milan, , Italy
IRCCS Ospedale Pediatrico Bambino Gesù, Roma, , Italy
National Cancer Center, Goyang-si, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital Yonsei University Health System, Seoul, , Korea, Republic of
Princess Maxima Center for Pediatric Oncology, Utrecht, , Netherlands
Auckland City Hospital, Auckland, , New Zealand
Starship Children's Hospital, Auckland, , New Zealand
KK Women's and Children's Hospital, Singapore, , Singapore
National Cancer Centre, Singapore, , Singapore
National University Hospital, Singapore, , Singapore
Hospital Universitario de Cruces, Barakaldo, , Spain
Hospital Sant Joan de Deu, Barcelona, , Spain
Hospital Universitario Vall d'Hebrón, Barcelona, , Spain
Hospital Infantil Universitario Niño Jesus, Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital Universitario Virgen del Rocio, Sevilla, , Spain
Hospital Universitari i Politecnic La Fe de Valencia, Valencia, , Spain
Drottning Silvias Barn Och Ungdomssjukhus, Göteborg, , Sweden
Skanes Universitetssjukhus Lund, Lund, , Sweden
Karolinska Universitetssjukhuset Solna, Stockholm, , Sweden
Centre Hospitalier Universitaire Vaudois, Lausanne, , Switzerland
Kinderspital Zürich - Eleonorenstiftung, Zürich, , Switzerland
National Taiwan University Hospital, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Birmingham Children's Hospital, Birmingham, , United Kingdom
The Royal Hospital for Children, Bristol, , United Kingdom
Royal Hospital for Children, Glasgow, , United Kingdom
Leeds Children Hospital, Leeds, , United Kingdom
Alder Hey Children's Hospital, Liverpool, , United Kingdom
UCL Cancer Institute, London, , United Kingdom
Royal Manchester Childrens Hospital, Manchester, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
Royal Victoria Infirmary, Newcastle, , United Kingdom
John Radcliffe Hospital, Oxford, , United Kingdom