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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

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ClinicalTrials.gov Identifier: NCT01599559
Recruitment Status : Recruiting
First Posted : May 16, 2012
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
International Extranodal Lymphoma Study Group (IELSG)

Brief 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trial is to test whether radiation therapy is really necessary in patients where PET/CT has shown that the tumor is no longer active.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.


Condition or disease Intervention/treatment Phase
Primary Mediastinal B-cell Lymphoma Other: observation Radiation: 3D-Conformal Radiotherapy (3D-CRT) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : November 2011
Actual Primary Completion Date : May 2017
Estimated Study Completion Date : May 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arm Intervention/treatment
Experimental: observation
Follow up visits are scheduled from randomization. Patients will be seen at 3-months intervals for 24 months, then every 6 months until 5 years from randomization.
Other: observation
observation

Active Comparator: mediastinal irradiation
Radiotherapy will be delivered in this phase III protocol, as alternative to observation, as consolidation treatment in patients achieving a CR status (PET/CT scan negative) at the end of R-chemotherapy, with a total dose of 30 Gy.
Radiation: 3D-Conformal Radiotherapy (3D-CRT)
Radiation treatment should start within 6-8 weeks after the end of chemotherapy.




Primary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: 2 years from the randomization ]

    The primary outcome endpoint will be Progression Free Survival (PFS) in patients PET-negative after R-chemotherapy.

    Failure events for PFS are progression (defined as an increase in size of existing masses or the development of new sites of disease using the same radiological investigations CT or PET/CT and/or MRI - as for the pre-chemotherapy assessment) or death from any cause.



Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: 5 years from registration ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01599559


Contacts
Contact: Emanuele Zucca, MD ++41 91 811 90 40 ielsg@eoc.ch

  Show 79 Study Locations
Sponsors and Collaborators
International Extranodal Lymphoma Study Group (IELSG)
Investigators
Study Chair: Maurizio Martelli, MD Università La Sapienza (Rome - Italy)
Study Chair: Andrew J Davies, MD University of Southampton (UK)
Study Chair: Mary Gospodarowicz, MD Princess Margaret Hospital Toronto (Canada)
Study Chair: Sally F Barrington, MD St. Thomas' - London (UK)
Study Chair: Alberto Biggi, MD AO S. Croce e Carle, Cuneo (Italia)
Study Chair: Annibale Versari, MD S.Maria Nuova Hospital, Reggio Emilia (Italia)
Study Chair: Gianni Ciccone, MD CPO Torino (Italy)
Study Chair: Stèphane Chauvie, MD AO S. Crtoce e Carle - Cuneo (Italy)
Study Chair: Luca Ceriani, MD IOSI - Bellinzona (Switzerland)

Responsible Party: International Extranodal Lymphoma Study Group (IELSG)
ClinicalTrials.gov Identifier: NCT01599559     History of Changes
Other Study ID Numbers: IELSG37
First Posted: May 16, 2012    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: July 2018

Keywords provided by International Extranodal Lymphoma Study Group (IELSG):
previously
untreated

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents