A clinico-pathologic study of Primary Mediastinal B-cell lymphoma

ISRCTN ISRCTN88720356
DOI https://doi.org/10.1186/ISRCTN88720356
EudraCT/CTIS number 2006-005794-22
ClinicalTrials.gov number NCT00944567
Secondary identifying numbers 4002
Submission date
31/03/2010
Registration date
31/03/2010
Last edited
10/09/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

http://cancerhelp.cancerresearchuk.org/trials/a-study-to-understand-more-about-the-growth-and-treatment-of-a-rare-type-of-non-hodgkins-lymphoma

Contact information

Mrs Joanne Simon
Scientific

University of Southampton Clinical Trials Unit, MP131
Tremona Road
Southampton
SO16 6YD
United Kingdom

Study information

Study designNon-randomised interventional multicentre process of care trial
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA clinico-pathologic study of Primary Mediastinal B-cell lymphoma
Study acronymIELSG 26
Study objectivesAim 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(s)First MREC approval date 12/06/2007 (ref: 07/Q1704/68)
Health condition(s) or problem(s) studiedTopic: National Cancer Research Network; Subtopic: Lymphoma; Disease: Lymphoma (non-Hodgkin's)
Interventionlymphoma, diffuse large B-cell lymphoma

Follow Up Length: 120 month(s)
Study Entry: Registration only
Intervention typeOther
Primary outcome measureResponse rate on PET scanning following initial chemotherapy and at the end of all treatment
Secondary outcome measures1. Progression Free Survival
2. Overall Survival
Overall study start date16/01/2009
Completion date31/05/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsPlanned Sample Size: 120; UK Sample Size: 120
Total final enrolment125
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment16/01/2009
Date of final enrolment31/05/2010

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University of Southampton Clinical Trials Unit, MP131
Southampton
SO16 6YD
United Kingdom

Sponsor information

Southampton University Hospitals NHS Trust (UK)
Hospital/treatment centre

Tremona Road
Southampton
SO16 6YD
England
United Kingdom

Website http://www.suht.nhs.uk/home.aspx
ROR logo "ROR" https://ror.org/0485axj58

Funders

Funder type

Research organisation

International Extranodal Lymphoma Study Group (IELSG) (Switzerland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Basic results 16/05/2019 No No
Results article results 10/06/2014 10/09/2019 Yes No
Results article results 20/08/2015 10/09/2019 Yes No
Results article results 12/07/2018 10/09/2019 Yes No

Editorial Notes

10/09/2019: The following changes were made to the trial record:
1. Publication references added.
2. ClinicalTrials.gov number added.
16/05/2019: The following changes were made to the trial record:
1. Added clinicaltrialsregister.eu link to basic results (scientific).
2. The total final enrollment was added.
15/03/2017: No publications found in PubMed, verifying study status with principal investigator