This Trial is a Randomized, Open-label 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
Conditions
Primary Mediastinal B-cell Lymphoma
Conditions: official terms
Lymphoma - Lymphoma, B-Cell
Conditions: Keywords
previously, untreated
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: observation Type: Other
Name: 3D-Conformal Radiotherapy (3D-CRT) Type: Radiation
Overall Status
Recruiting
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trial is to test whether radiation therapy is really necessary in patients where PET/CT has shown that the tumor is no longer active.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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Previously untreated primary mediastinal diffuse large B-cell lymphoma, CD20 positive.

- Patients must have histological confirmation of the diagnosis (it is recommended that the immunohistochemical panel includes: CD45, CD20, CD30, CD15, CD10, BCL6, BCL2, MUM-1), and in addition have a dominant mass within the anterior mediastinum.

- No evidence of extranodal disease outside the chest including spleen and bone marrow.

- Age at least 18 years.

- Fit to receive chemotherapy and radiotherapy with curative intent.

- Patients will be eligible if the treatment phase consisting in a Rituximab combined with any anthracycline-containing chemotherapy regimen without consolidation with autologous stem cell support (e.g., 6 cycles of CHOP14-21, DA-EPOCH, Mega-CHOP or 12 weeks of VACOP-B or MACOP-B).

- At least 6 courses of Rituximab should be administered

- Able and willing to give informed consent, and to undergo staging including PET scanning

- Willingness to comply with an appropriate contraceptive method in women of childbearing potential or men.

- Histological diagnostic material available for review.

Exclusion Criteria:

- History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 5 years.

- Evidence of clinically significant cardiac disease at diagnosis, as defined by history of symptomatic ventricular arrhythmias, congestive heart failure or myocardial infarction within 12 months before study entry. Cardiac impairment due to local extension of lymphoma will not be an exclusion criterion in the absence of other cardiac disease.

- Known HIV-positive serology.

- Pregnant or lactating women.

- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
Locations
Mayo Clinil Rocheser
Rochester, Minnesota, United States
Status: Recruiting
Contact: Grzegorz Nowakowski
Nebraska Medical Centre
Omaha, Nebraska, United States
Status: Withdrawn
Centro de Hematologia y Oncologia Pavlovsky
Buenos Aires, Argentina
Status: Not yet recruiting
Contact: Astrid Pavlovski
Princess Margaret Hospital
Toronto, Canada
Status: Recruiting
Contact: David Hodgson, MD
A.O. SS. Antonio e Biagio e Cesare Arrigo
Alessandria, Italy
Status: Recruiting
Contact: Flavia Salvi, MD
Clinica di Ematologia Ospedali Riuniti "Umberto I"
Ancona, Italy
Status: Recruiting
Contact: Guido Gini
Centro di Riferimento Oncologico - Aviano
Aviano, Italy
Status: Recruiting
Contact: Michele Spina
A.O.U Policlinico Consorziale di Bari
Bari, Italy
Status: Recruiting
Contact: Giorgina Specchia, Prof
Bari IRCCS Istituto Tumori
Bari, Italy
Status: Recruiting
Contact: Attilio Guarini
Sant'Orsola Malpighi
Bologna, Italy
Status: Recruiting
Contact: Vittorio Stefoni
Comprensorio Sanitario di Bolzano
Bolzano, Italy
Status: Recruiting
Contact: Atto Billio
Spedali Civili
Brescia, Italy
Status: Recruiting
Contact: Giuseppe Rossi
Ospedale Businco
Cagliari, Italy
Status: Recruiting
Contact: Giuseppina Cabras
AO Garibaldi Nesima Catalia
Catania, Italy
Status: Recruiting
Contact: Ugo Consoli
Policlinico Careggi
Firenze, Italy
Status: Recruiting
Contact: Luigi Rigacci, MD
Unità Funzionale di Ematologia AOU Careggi
Firenze, Italy
Status: Recruiting
Contact: Alberto Bosi
U.O. Ematologia Vito Fazzi
Lecce, Italy
Status: Recruiting
Contact: Nicola De Renzi
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, Italy
Status: Recruiting
Contact: Gerardo Musuraca
SC Ematologia Azienda Ospedali Riuniti Papardo Piemonte
Messina, Italy
Status: Recruiting
Contact: Donato Mannina
Istituto Scientifico San Raffaele
Milano, Italy
Status: Recruiting
Contact: Andrés Ferreri, MD
SC Ematologia AO Niguarda
Milano, Italy
Status: Recruiting
Contact: Chiara Rusconi, MD
AOU Policlinico di Modena
Modena, Italy
Status: Recruiting
Contact: Stefano Luminari
Ematologia Università degli Studi di Federico II
Napoli, Italy
Status: Recruiting
Contact: Amalia De Renzo
Ospedale Umberto I
Nocera, Italy
Status: Recruiting
Contact: Alfonso D'Arco
Ospedali Riuniti Villa Sofia
Palermo, Italy
Status: Recruiting
Contact: Caterina Patti
AOU di Parma
Parma, Italy
Status: Recruiting
Contact: Francesca Re
Fondazione IRCCS S. Matteo
Pavia, Italy
Status: Recruiting
Contact: Luca Arcaini
Ospedale Civico Guglielmo di Saliceto
Piacenza, Italy
Status: Recruiting
Contact: Daniele Vallisa
A.O. Bianchi-Melacrino-Morelli, Divisione di Ematologia
Reggio Calabria, Italy
Status: Recruiting
Contact: Caterina Stelitano, MD
ICCRS Azienda Ospedaliera Arcipedale "Santa Maria Nuova"
Reggio Emilia, Italy
Status: Recruiting
Contact: Francesco Merli
AO San Camillo Forlanini
Roma, Italy
Status: Recruiting
Contact: Roberta Battistini
AOU S. Andrea Roma
Roma, Italy
Status: Recruiting
Contact: Maria Christina Cox
Ospedale S. Eugenio
Roma, Italy
Status: Recruiting
Contact: Elisabetta Abruzzese
Roma Regina Elena IFO
Roma, Italy
Status: Recruiting
Contact: Francesco Pisani
Roma San Giovanni
Roma, Italy
Status: Recruiting
Contact: Paola Anticoli
Università degli Studi La Sapienza
Roma, Italy
Status: Recruiting
Contact: Maurizio Martelli, MD
Rozzano Humanitas
Rozzano, Italy
Status: Recruiting
Contact: Monica Balzarotti
Siena
Siena, Italy
Status: Recruiting
Contact: Alberto Fabbri
AOS Maria di Terni
Terni, Italy
Status: Recruiting
Contact: Anna Marina Liberati
AOS S. Giovanni Battista "Molinette"
Torino, Italy
Status: Recruiting
Contact: Umberto Vitolo
Ospedale Maggiore San Giovanni Battista
Torino, Italy
Status: Recruiting
Contact: Umberto Vitolo, MD
Ospedale Cardinale Panico
Tricase, Italy
Status: Recruiting
Contact: Vincenzo Pavone
Azienda Ospedaliera Univesritaria
Udine, Italy
Status: Recruiting
Contact: Francesco Zaja
Ospedale dell'Angelo
Venezia Mestre, Italy
Status: Recruiting
Contact: Renato Bassan
Oslo University Hospital
Oslo, Norway
Status: Recruiting
Contact: Alexander Fossa, MD
St Olavs Hospital
Trondheim, Norway
Status: Recruiting
Contact: Unn-Merete Fagerli, MD
Lund Universitet
Lund, Sweden
Status: Recruiting
Contact: Mats Jerkeman
IOSI
Bellinzona, Switzerland
Status: Recruiting
Contact: Emanuele Zucca, MD
Inselspital Bern
Bern, Switzerland
Status: Recruiting
Contact: Codruta Ionescu, MD
Kantonsspital
St Gallen, Switzerland
Status: Recruiting
Contact: Felicitas Hitz, MD
Kyiv National Cancer Institute
Kiev, Ukraine
Status: Recruiting
Contact: Irina Kryachok
National Cancer Institute
Kyiv, Ukraine
Status: Recruiting
Contact: Irina Kryachok, MD
Basingstoke & North Hamptshire Hospital
Basingstoke, United Kingdom
Status: Recruiting
Contact: Alison Milne
University Hospital Coventry & Warwickshire NHS Trust
Coventry, United Kingdom
Status: Recruiting
Contact: Clive Irvin
Plimouth Derriford Hospital
Derriford, United Kingdom
Status: Recruiting
Contact: Simon Rule
Glasgow Beatson Cancer Center
Glasgow, United Kingdom
Status: Recruiting
Contact: Pam Mc Kay
Leeds St. James's Hospital
Leeds, United Kingdom
Status: Recruiting
Contact: Rod Johnson
Guy's & St. Thomas London
London, United Kingdom
Status: Recruiting
Contact: George Mikhaeel
UCLH St. Thomas
London, United Kingdom
Status: Recruiting
Contact: Kirit Ardeshna
Manchester The Christie NHS Foundation Trust
Manchester, United Kingdom
Status: Recruiting
Contact: Tim Illdge
Newcastle Freeman Hospital
Newcastle, United Kingdom
Status: Recruiting
Contact: Anne Lennard
General Hospital
Southampton, United Kingdom
Status: Recruiting
Contact: Andrew Davies, MD
Start Date
November 2011
Completion Date
May 2025
Sponsors
International Extranodal Lymphoma Study Group (IELSG)
Source
International Extranodal Lymphoma Study Group (IELSG)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page