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

ISRCTN	ISRCTN88720356
DOI	https://doi.org/10.1186/ISRCTN88720356
ClinicalTrials.gov (NCT)	NCT00944567
Clinical Trials Information System (CTIS)	2006-005794-22
Protocol serial number	4002
Sponsor	Southampton University Hospitals NHS Trust (UK)
Funder	International Extranodal Lymphoma Study Group (IELSG) (Switzerland)

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

Primary study design	Interventional
Study design	Non-randomised interventional multicentre process of care trial
Secondary study design	Non randomised study
Study type	Participant information sheet
Scientific title	A clinico-pathologic study of Primary Mediastinal B-cell lymphoma
Study acronym	IELSG 26
Study objectives	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(s)	First MREC approval date 12/06/2007 (ref: 07/Q1704/68)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Response rate on PET scanning following initial chemotherapy and at the end of all treatment
Key secondary outcome measure(s)	1. Progression Free Survival 2. Overall Survival
Completion date	31/05/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	120
Total final enrolment	125
Key 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
Key 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
Date of first enrolment	16/01/2009
Date of final enrolment	31/05/2010

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University of Southampton Clinical Trials Unit, MP131

Southampton
SO16 6YD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
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
Basic results			16/05/2019	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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