Condition category
Cancer
Date applied
31/03/2010
Date assigned
31/03/2010
Last edited
11/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Mrs Joanne Simon

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

2006-005794-22

ClinicalTrials.gov number

Protocol/serial number

4002

Study information

Scientific title

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 controlled trial

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 measures

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

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

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

http://www.suht.nhs.uk/home.aspx

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes