A clinico-pathologic study of Primary Mediastinal B-cell lymphoma
ISRCTN | ISRCTN88720356 |
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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
Plain English summary of protocol
Contact information
Scientific
University of Southampton Clinical Trials Unit, MP131
Tremona Road
Southampton
SO16 6YD
United Kingdom
Study information
Study design | Non-randomised interventional multicentre process of care trial |
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Primary study design | Interventional |
Secondary study design | Non randomised study |
Study setting(s) | Hospital |
Study type | Diagnostic |
Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 16/01/2009 |
Completion date | 31/05/2010 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | Planned Sample Size: 120; UK Sample Size: 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
- England
- United Kingdom
Study participating centre
SO16 6YD
United Kingdom
Sponsor information
Hospital/treatment centre
Tremona Road
Southampton
SO16 6YD
England
United Kingdom
Website | http://www.suht.nhs.uk/home.aspx |
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https://ror.org/0485axj58 |
Funders
Funder type
Research organisation
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not 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