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Radiation-Free hope for mediastinal lymphoma patients

NCT ID NCT01599559

Disease control Sponsor: International Extranodal Lymphoma Study Group (IELSG) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether people with a type of lymphoma (primary mediastinal large B-cell lymphoma) can safely avoid radiation therapy after standard chemoimmunotherapy if a PET/CT scan shows no active tumor. About 540 patients who had a negative PET/CT after treatment were randomly assigned to either receive radiation or just careful observation. The goal is to see if observation is as good as radiation at preventing the cancer from coming back, which could spare patients from unnecessary radiation side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
observation (no additional treatment) vs. mediastinal radiation therapy
What this could lead to
If successful, this could spare many lymphoma patients from unnecessary radiation and its long-term side effects, while still keeping the cancer under control.
What could go wrong
This is an active but not recruiting trial, and results are not yet available. It is possible that skipping radiation could lead to higher relapse rates, so caution is needed until final data are published.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 540 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2012

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

primary mediastinal large B-cell lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Primary mediastinal B cell lymphoma

Contacts and locations

Locations

  • A.O. Bianchi-Melacrino-Morelli, Divisione di Ematologia

    Reggio Calabria, Italy

  • A.O. SS. Antonio e Biagio e Cesare Arrigo

    Alessandria, Italy

  • A.O.U Policlinico Consorziale di Bari

    Bari, Italy

  • AO Garibaldi Nesima Catalia

    Catania, Italy

  • AO San Camillo Forlanini

    Roma, Italy

  • AOS Maria di Terni

    Terni, Italy

  • AOS S. Giovanni Battista "Molinette"

    Torino, Italy

  • AOU Policlinico di Modena

    Modena, Italy

  • AOU S. Andrea Roma

    Roma, Italy

  • AOU di Parma

    Parma, Italy

  • Asl Uoc Ematologia A Perrino

    Brindisi, Italy

  • Asst Settelaghi Ospedale Macchi

    Varese, Italy

  • Azienda Ospedaliera Citta Della Salute E Della Scienza Di Torino

    Torino, Italy

  • Azienda Ospedaliera Universitaria

    Padova, Italy

  • Azienda Ospedaliera Univesritaria

    Udine, Italy

  • Bari IRCCS Istituto Tumori

    Bari, Italy

  • Basingstoke & North Hamptshire Hospital

    Basingstoke, United Kingdom

  • Birmingham Heartlands Hospital

    Birmingham, United Kingdom

  • Centro de Hematologia y Oncologia Pavlovsky

    Buenos Aires, Argentina

  • Centro di Riferimento Oncologico - Aviano

    Aviano, Italy

  • Clinica di Ematologia Ospedali Riuniti "Umberto I"

    Ancona, Italy

  • Comprensorio Sanitario di Bolzano

    Bolzano, Italy

  • Ematologia Università degli Studi di Federico II

    Naples, Italy

  • Faculty Hospital Brno

    Brno, Czechia

  • Faculty Hospital Kralovske Vinohrady

    Prague, Czechia

  • Fondazione IRCCS S. Matteo

    Pavia, Italy

  • Fondazione PTV Policlinico Tor Vergata

    Roma, 00133, Italy

  • General Hospital

    Southampton, United Kingdom

  • General University Hospital

    Prague, Czechia

  • Glasgow Beatson Cancer Center

    Glasgow, United Kingdom

  • Guy's & St. Thomas London

    London, United Kingdom

  • ICCRS Azienda Ospedaliera Arcipedale "Santa Maria Nuova"

    Reggio Emilia, Italy

  • IOSI

    Bellinzona, 6500, Switzerland

  • Inselspital Bern

    Bern, Switzerland

  • Istituto Portugues de Oncologia de Lisboa

    Lisbon, Portugal

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    Meldola, Italy

  • Istituto Scientifico San Raffaele

    Milan, Italy

  • Kantonsspital

    Sankt Gallen, Switzerland

  • Kantonsspital Olten

    Olten, Switzerland

  • Kyiv National Cancer Institute

    Kiev, Ukraine

  • Leeds St. James's Hospital

    Leeds, United Kingdom

  • Lund Universitet

    Lund, Sweden

  • MD Anderson Cancer Center

    Houston, Texas, United States

  • Manchester The Christie NHS Foundation Trust

    Manchester, United Kingdom

  • Mayo Clinil Rocheser

    Rochester, Minnesota, 55905, United States

  • Milano Ieo

    Milan, Italy

  • Newcastle Freeman Hospital

    Newcastle, United Kingdom

  • Norfolk & Norwich University Hospital

    Norfolk, United Kingdom

  • Norton Cancer Institute

    Louisville, Kentucky, United States

  • Nottingham University Hospital

    Nottingham, United Kingdom

  • Oslo University Hospital

    Oslo, Norway

  • Ospedale Businco

    Cagliari, Italy

  • Ospedale Cardinale Panico

    Tricase, Italy

  • Ospedale Civico Guglielmo di Saliceto

    Piacenza, Italy

  • Ospedale Civile di Pescara

    Pescara, Italy

  • Ospedale Degli Infermi

    Rimini, Italy

  • Ospedale Mons. Dimiccoli

    Barletta, Italy

  • Ospedale Papa Giovanni Xxiii

    Bergamo, Italy

  • Ospedale S. Croce e Carle

    Cuneo, Italy

  • Ospedale S. Eugenio

    Roma, Italy

  • Ospedale San Carlo di Potenza

    Potenza, Italy

  • Ospedale Umberto I

    Nocera Inferiore, Italy

  • Ospedali Riuniti Villa Sofia

    Palermo, Italy

  • Policlinico Universitario Campus Bio-Medico

    Roma, Italy

  • Princess Margaret Hospital

    Toronto, Canada

  • Roma Regina Elena IFO

    Roma, Italy

  • Roma San Giovanni

    Roma, Italy

  • Royal Liverpool University Hospital

    Liverpool, United Kingdom

  • Rozzano Humanitas

    Rozzano, Italy

  • Ruijin Hospital

    Shanghai, China

  • S.C. Ematologia Ospedale S. Marid Della Misericordia

    Perugia, Italy

  • SC Ematologia AO Niguarda

    Milan, Italy

  • SC Ematologia Azienda Ospedali Riuniti Papardo Piemonte

    Messina, Italy

  • Sant'Orsola Malpighi

    Bologna, Italy

  • Siena

    Siena, Italy

  • Spedali Civili

    Brescia, Italy

  • St Olavs Hospital

    Trondheim, Norway

  • U.O. Ematologia Vito Fazzi

    Lecce, Italy

  • U.O. Oncologia Ematologia Ospedale S. Maria Delle Croci

    Ravenna, Italy

  • UCLH St. Thomas

    London, United Kingdom

  • Unità Funzionale di Ematologia AOU Careggi

    Florence, Italy

  • University Hospital

    Hradec Králové, Czechia

  • University of Duisburg-Essen, Campus Essen

    Essen, Germany

  • Università degli Studi La Sapienza

    Roma, Italy

  • Warsaw Centrum Onkologi Instytucie

    Warsaw, Poland

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