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Randomized, Open-label, Two-arms, Phase III Comparative Study Assessing the Role of Involved Mediastinal Radiotherapy After Rituximab Containing Chemotherapy Regimens to Patients With Newly Diagnosed Primary Mediastinal Large B-Cell Lymphoma
Sponsor: International Extranodal Lymphoma Study Group (IELSG)
Summary
Primary mediastinal large B cell lymphoma is treated with a combination of chemotherapy and the monoclonal antibody rituximab (chemoimmunotherapy). Following chemoimmunotherapy patients receive radiation therapy if they have residues which may be active tumour. However at the end of chemoimmunotherapy the majority of patients show tissue scarring that is not necessarily active tumor. In recent years, PET/CT has proved to be a good tool to accurately identify active tumor from scar tissue in patients treated for mediastinal lymphoma.The purpose of this trial is to test whether radiation therapy is really necessary in patients where PET/CT has shown that the tumor is no longer active. Therefore we will compare radiation treatment with careful observation. Patients that at the end of conventional treatment of chemoimmunotherapy have a negative PET/CT (i.e., without residues suspected to contain active tumor), will randomly assigned to two different treatment groups: one treatment group will receive the radiation treatment, and the other treatment group will receive careful observation. The trial is planned according to a non-inferiority design aimed at demonstrating that progression free survival after the experimental treatment (observation) is not worse than after the standard comparator (mediastinal irradiation.Participation in this study could spare patients with complete remission at the end of chemo immunotherapy (PET/CT negative) radiation therapy that may be unnecessary.
Official title: IELSG37: A Randomized, Open-label, Multicentre, Two-arm Phase III Comparative Study Assessing the Role of Involved Mediastinal Radiotherapy After Rituximab Containing Chemotherapy Regimens to Patients With Newly Diagnosed Primary Mediastinal Large B-Cell Lymphoma (PMLBCL)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
540
Start Date
2012-10
Completion Date
2029-12-17
Last Updated
2026-01-15
Healthy Volunteers
No
Conditions
Interventions
observation
observation
3D-Conformal Radiotherapy (3D-CRT)
Radiation treatment should start within 6-8 weeks after the end of chemotherapy.
Locations (85)
Norton Cancer Institute
Louisville, Kentucky, United States
Mayo Clinil Rocheser
Rochester, Minnesota, United States
MD Anderson Cancer Center
Houston, Texas, United States
Centro de Hematologia y Oncologia Pavlovsky
Buenos Aires, Argentina
Princess Margaret Hospital
Toronto, Canada
Ruijin Hospital
Shanghai, China
Faculty Hospital Brno
Brno, Czechia
University Hospital
Hradec Králové, Czechia
Faculty Hospital Kralovske Vinohrady
Prague, Czechia
General University Hospital
Prague, Czechia
University of Duisburg-Essen, Campus Essen
Essen, Germany
A.O. SS. Antonio e Biagio e Cesare Arrigo
Alessandria, Italy
Clinica di Ematologia Ospedali Riuniti "Umberto I"
Ancona, Italy
Centro di Riferimento Oncologico - Aviano
Aviano, Italy
A.O.U Policlinico Consorziale di Bari
Bari, Italy
Bari IRCCS Istituto Tumori
Bari, Italy
Ospedale Mons. Dimiccoli
Barletta, Italy
Ospedale Papa Giovanni Xxiii
Bergamo, Italy
Sant'Orsola Malpighi
Bologna, Italy
Comprensorio Sanitario di Bolzano
Bolzano, Italy
Spedali Civili
Brescia, Italy
Asl Uoc Ematologia A Perrino
Brindisi, Italy
Ospedale Businco
Cagliari, Italy
AO Garibaldi Nesima Catalia
Catania, Italy
Ospedale S. Croce e Carle
Cuneo, Italy
Unità Funzionale di Ematologia AOU Careggi
Florence, Italy
U.O. Ematologia Vito Fazzi
Lecce, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, Italy
SC Ematologia Azienda Ospedali Riuniti Papardo Piemonte
Messina, Italy
Istituto Scientifico San Raffaele
Milan, Italy
Milano Ieo
Milan, Italy
SC Ematologia AO Niguarda
Milan, Italy
AOU Policlinico di Modena
Modena, Italy
Ematologia Università degli Studi di Federico II
Naples, Italy
Ospedale Umberto I
Nocera Inferiore, Italy
Azienda Ospedaliera Universitaria
Padova, Italy
Ospedali Riuniti Villa Sofia
Palermo, Italy
AOU di Parma
Parma, Italy
Fondazione IRCCS S. Matteo
Pavia, Italy
S.C. Ematologia Ospedale S. Marid Della Misericordia
Perugia, Italy
Ospedale Civile di Pescara
Pescara, Italy
Ospedale Civico Guglielmo di Saliceto
Piacenza, Italy
Ospedale San Carlo di Potenza
Potenza, Italy
U.O. Oncologia Ematologia Ospedale S. Maria Delle Croci
Ravenna, Italy
A.O. Bianchi-Melacrino-Morelli, Divisione di Ematologia
Reggio Calabria, Italy
ICCRS Azienda Ospedaliera Arcipedale "Santa Maria Nuova"
Reggio Emilia, Italy
Ospedale Degli Infermi
Rimini, Italy
Fondazione PTV Policlinico Tor Vergata
Roma, Italy
AO San Camillo Forlanini
Roma, Italy
AOU S. Andrea Roma
Roma, Italy
Ospedale S. Eugenio
Roma, Italy
Policlinico Universitario Campus Bio-Medico
Roma, Italy
Roma Regina Elena IFO
Roma, Italy
Roma San Giovanni
Roma, Italy
Università degli Studi La Sapienza
Roma, Italy
Rozzano Humanitas
Rozzano, Italy
Siena
Siena, Italy
AOS Maria di Terni
Terni, Italy
AOS S. Giovanni Battista "Molinette"
Torino, Italy
Azienda Ospedaliera Citta Della Salute E Della Scienza Di Torino
Torino, Italy
Ospedale Cardinale Panico
Tricase, Italy
Azienda Ospedaliera Univesritaria
Udine, Italy
Asst Settelaghi Ospedale Macchi
Varese, Italy
Oslo University Hospital
Oslo, Norway
St Olavs Hospital
Trondheim, Norway
Warsaw Centrum Onkologi Instytucie
Warsaw, Poland
Istituto Portugues de Oncologia de Lisboa
Lisbon, Portugal
Lund Universitet
Lund, Sweden
IOSI
Bellinzona, Switzerland
Inselspital Bern
Bern, Switzerland
Kantonsspital Olten
Olten, Switzerland
Kantonsspital
Sankt Gallen, Switzerland
Kyiv National Cancer Institute
Kiev, Ukraine
Basingstoke & North Hamptshire Hospital
Basingstoke, United Kingdom
Birmingham Heartlands Hospital
Birmingham, United Kingdom
Glasgow Beatson Cancer Center
Glasgow, United Kingdom
Leeds St. James's Hospital
Leeds, United Kingdom
Royal Liverpool University Hospital
Liverpool, United Kingdom
Guy's & St. Thomas London
London, United Kingdom
UCLH St. Thomas
London, United Kingdom
Manchester The Christie NHS Foundation Trust
Manchester, United Kingdom
Newcastle Freeman Hospital
Newcastle, United Kingdom
Norfolk & Norwich University Hospital
Norfolk, United Kingdom
Nottingham University Hospital
Nottingham, United Kingdom
General Hospital
Southampton, United Kingdom