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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

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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