Spots Global Cancer Trial Database for Second International Inter-Group Study for Classical Hodgkin Lymphoma in Children and Adolescents
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Trial Identification
Brief Title: Second International Inter-Group Study for Classical Hodgkin Lymphoma in Children and Adolescents
Official Title: European Network-Paediatric Hodgkin Lymphoma Study Group (EuroNet-PHL) Second International Inter-Group Study for Classical Hodgkin Lymphoma in Children and Adolescents
Study ID: NCT02684708
Conditions
Study Description
Brief Summary: The EuroNet-PHL-C2 trial is an international, multicentre, randomised controlled trial with the aims to reduce the indication for radiotherapy in newly diagnosed patients with classical Hodgkin lymphoma without compromising cure rates and to investigate a chemotherapy intensification randomisation in intermediate and advanced classical Hodgkin lymphoma to compensate for reduction in radiotherapy.
Detailed Description: EuroNet-PHL-C2 is a comprehensive treatment strategy for all first line classical Hodgkin Lymphoma (cHL) patients under 18 years (under 25 years in UK, Italy and France). The overall strategy is risk stratified (defining chemotherapy) and response adapted (defining radiotherapy) to tailor the amount of treatment to the individual patient and decrease long term complications. * Radiotherapy indication will be restricted. Patients with a negative PET scan after two cycles of OEPA chemotherapy (Early Response Assessment - ERA) will not receive radiotherapy. The threshold for negative PET scan at ERA shifts from the previously used Deauville 1 and 2 = negative (as in the C1 trial) to Deauville 1, 2 and 3 = negative, thereby increasing the number of negative patients without indication for RT. * Chemotherapy Randomisation All intermediate (TL-2) and advanced stage (TL-3) patients will be randomised between respectively 2 or 4 standard COPDAC-28 or intensified DECOPDAC-21 consolidation chemotherapy cycles. To avoid delayed consolidation, randomisation has to be performed before ERA and as soon as the TL-assignment is confirmed by central review. Therefore two randomised sub-studies arise based on the ERA PET response: Patients with adequate response at ERA do not receive radiotherapy - a randomised controlled chemotherapy comparison to show that intensified DECOPDAC-21 consolidation chemotherapy improves EFS as compared to standard COPDAC-28 Patients with inadequate response at ERA - a randomised controlled chemotherapy-radiotherapy comparison - to show that DECOPDAC-21 combined with radiotherapy restricted to sites that remain FDG-PET positive at the end of all chemotherapy (Late response assessment - LRA) has comparable EFS compared to COPDAC-28 plus standard involved node radiotherapy as in the C1 trial. * Risk stratification is refined Former treatment groups (TG) of the EuroNet-PHL-C1 trial are reassigned into treatment levels (TL) by shifting early stage patients (former TG-1) with risk factors into TL-2. * Semi-quantitative 'qPET' Results of semi-quantitative qPET are formally integrated into the response assessment.
Keywords
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Royal Children's Hospital and Monash Medical Centre Royal Children's Hospital, Victoria Park, , Australia
St. Anna Kinderspital, Wien, , Austria
Paediatric haemato-oncology, University Hospitals of Leuven, Leuven, , Belgium
Dpt. of Pediatric Hematology and Oncology, Faculty Hospital Motol, Prague, , Czechia
Department of Pediatric Hematology/Oncology (5054) The Child and Youth Clinic, University Hospital of Copenhagen, Copenhagen, , Denmark
Service d'Oncohématologie, Hopital d'Ènfants Armand Trousseau, Paris, , France
Justus Liebig University of Giessen, Giessen, , Germany
Our Lady's Children's Hospital, Crumlin, Dublin, , Ireland
Tel Aviv University Schneider Children's Medical Center of Israel The Rina Zaizov Pediatric Hematology Oncology Division, Petach Tikva, , Israel
Pediatric Radiotherapy and Youth Area Unit C.R.O. - Centro di Riferimento Oncologico IRCCS, Aviano, , Italy
Princess Máxima Center for pediatric oncology, Utrecht, , Netherlands
Starship Blood and Cancer Centre, Starship Children's Hospital, Auckland, , New Zealand
Department of Medical Oncology Oslo University Hospital, Oslo, , Norway
Head of Department of Pediatric Oncology and Hematology, Polish-American Pediatric Institute, Jagiellonian University Medical Faculty, Kraków, , Poland
Clinic of Pediatric Oncology University Children's Hospital, Bratislava, , Slovakia
Sección de Onco-Hematología Pediátrica Hospital Universitario Virgen Macarena y Virgen del Rocío, Sevilla, , Spain
Pediatric Hematology & Oncology Children´s University Hospital, Uppsala, , Sweden
CHUV - Centre Hospitalier Universitaire Vaudois = LS, Départment femme - meré - enfant, Service de pédiatrie, Unité d'hématologie-oncologie pédiatrique, Lausanne, , Switzerland
University College London Hospitals, London, , United Kingdom
Contact Details
Name: Dieter Koerholz, MD
Affiliation: Justus-Liebig University of Giessen
Role: STUDY_CHAIR
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