Plain English Summary
Trial website
Additional identifiers
EudraCT number
2006-005794-22
ClinicalTrials.gov number
NCT00944567
Protocol/serial number
4002
Study information
Scientific title
A clinico-pathologic study of Primary Mediastinal B-cell lymphoma
Acronym
IELSG 26
Study hypothesis
Aim of the study is to evaluate prospectively the role of PET-scans in the management of primary mediastinal lymphoma treated with convential approaches.
Ethics approval
First MREC approval date 12/06/2007 (ref: 07/Q1704/68)
Study design
Non-randomised interventional multicentre process of care trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: National Cancer Research Network; Subtopic: Lymphoma; Disease: Lymphoma (non-Hodgkin's)
Intervention
lymphoma, diffuse large B-cell lymphoma
Follow Up Length: 120 month(s)
Study Entry: Registration only
Intervention type
Other
Phase
Phase III
Drug names
Primary outcome measure
Response rate on PET scanning following initial chemotherapy and at the end of all treatment
Secondary outcome measures
1. Progression Free Survival
2. Overall Survival
Overall trial start date
16/01/2009
Overall trial end date
31/05/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Primary mediastinal diffuse large B-cell lymphoma, CD20 positive. Patients must have histological confirmation of the diagnosis, and in addition have a dominant mass within the anterior mediastinum.
2. No prior treatment of lymphoma. Patients may have received corticosteroids for up to 1 week for the relief of local compressive symptoms.
3. Any stage of disease
4. Age at least 18 years
5. Fit to receive chemotherapy with curative intent
6. Able and willing to give informed consent, and to undergo staging including PET scanning
7. Willingness to comply with an appropriate contraceptive method in women of childbearing potential or men
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 120; UK Sample Size: 120
Total final enrolment
125
Participant exclusion criteria
1. Evidence of clinically significant cardiac disease, as defined by history of symptomatic ventricular arrhythmias, congestive heart failure or myocardial infarction within 12 months before study entry
2. Cardiac compromise due to local extension of lymphoma will not be an exclusion criterion in the absence of other cardiac disease
3. Impairment of bone marrow function (WBC < 3.0 x 10^9/L, ANC < 1.5 x 10^9/L, PLT < 100 x 10^9/L), unless due to involvement by lymphoma
4. Major impairment of renal function (serum creatinine > 2 x upper normal) or liver function (ASAT/ALAT > 2.5 x upper normal, total bilirubin > 2.5 x upper normal), unless due to lymphoma involvement
5. Known HIV infection. Patients will not be tested routinely.
6. Pregnant or lactating women
7. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
Recruitment start date
16/01/2009
Recruitment end date
31/05/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Southampton Clinical Trials Unit, MP131
Southampton
SO16 6YD
United Kingdom
Sponsor information
Organisation
Southampton University Hospitals NHS Trust (UK)
Sponsor details
Tremona Road
Southampton
SO16 6YD
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
International Extranodal Lymphoma Study Group (IELSG) (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
https://www.clinicaltrialsregister.eu/ctr-search/trial/2006-005794-22/results (added 16/05/2019)
Publication list
2014 results in: https://www.ncbi.nlm.nih.gov/pubmed/24799481 (added 10/09/2019)
2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/26089397 (added 10/09/2019)
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29720487 (added 10/09/2019)