Contact information
Type
Scientific
Primary contact
Prof Stephen John Proctor
ORCID ID
Contact details
Academic Haematology
Leech Building
Medical School
University of Newcastle upon Tyne
Newcastle upon Tyne
NE2 4HH
United Kingdom
+44 (0) 191 222 7791
s.j.proctor@ncl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00079105
Protocol/serial number
Version 3: 20.1.2005
Study information
Scientific title
A phase II study of vinblastine, endoxana (cyclophosphamide), procarbazine, prednisolone, etoposide, mitoxantrone and bleomycin in patients with Hodgkin's lymphoma aged over 60 years
Acronym
SHIELD Study
Study hypothesis
Progress in the treatment of Hodgkins Lymphoma (HL) in patients under 60 years has been substantial but in the over 60 years age group only small studies have been conducted and limited progress in outcome has been seen. It is necessary to create a starting point of uniform treatment for HL in the over 60 years age group, giving potentially curative treatment in a form that would be acceptable to individuals in this age group.
Nationally and internationally there is no existing co-ordinated study of HL in this age group and recent data indicates that outcome has not improved in the last 15 years. A number of older patients with HL fail to enter clinical trials as they are "not fit" for multiple drug chemotherapy. This study will aim to register all pathologically eligible patients in participating centres in order to provide a clearer overall clinical picture of this disease, whether or not they undergo protocol chemotherapy.
This study is of a phase II nature that aims to assess the efficacy, toxicity and applicability of the Vinblastine, Endoxana (cyclophosphamide), Procarbazine, Prednisolone, Etoposide, Mitoxantrone and Bleomycin (VEPEMB) chemotherapy schedule in this particular patient population, as a prelude to a subsequent randomised trial. The linking of this phase II study with total data collection aims to assess:
1. The proportions of patients who can enter a study of curative intent within this age group.
2. To assess complete response rate, event free survival and overall survival following this treatment schedule.
Please note that, as of 12/12/2008, the anticipated end date of this trial has been updated from 31/08/2007 to 31/08/2009.
Ethics approval
Thames Valley Multi-Centre Research Ethics Committee, reference number: 03/12/062.
Study design
Phase II two-arm non-randomised clinical study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Patient information can be found at: http://www.shieldstudy.co.uk/publicdocs/VEPEMBV5.doc
Condition
Hodgkin's lymphoma
Intervention
The patient either receives the VEPEMB treatment or is simply registered on the database and the alternative treatment which they receive is recorded. The patient's treatment is determined by their physicians who assess their 'fragility'. If they are too 'fragile' they will not be given the VEPEMB regimen.
Intervention type
Drug
Phase
Phase II
Drug names
Vinblastine, Endoxana (cyclophosphamide), Procarbazine, Prednisolone, Etoposide, Mitoxantrone and Bleomycin
Primary outcome measure
The primary endpoints will be progression-free survival, with clinical progression and death as the events. On suspicion of progression (e.g. new or enlarging masses, development of B symptoms) patients should be re-evaluated according to normal procedures to confirm relapse. Histological confirmation of relapse is recommended but not mandatory.
Survival time, including death from any cause, will also be investigated. For both endpoints, the event-free times will be dated from the date of histological diagnosis.
Secondary outcome measures
Analysis will be done to assess potential prognostic factors (Epstein-Barr Virus [EBV] status, "Fragility" assessment, Hasenclever index, soluble form of the CD30 molecule [sCD30]) which might be relevant in this age group.
Overall trial start date
01/09/2004
Overall trial end date
31/08/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Histologically confirmed classical Hodgkin's Lymphoma (HL)
2. No previous treatment for HL
3. Aged over 60
4. "Non fragile" patients, i.e. patients mental and physical status must be sufficient to withstand the treatment described
5. No concomitant neoplasia or known Human Immunodeficiency Virus (HIV) infection
6. Written informed consent
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
150
Participant exclusion criteria
1. Nodular Lymphocyte Predominance Hodgkin's Lymphoma (NLPHL)
2. Aged under 60
3. Patient previously treated for HL
4. Known HIV infection or concomitant neoplasia
5. "Fragile patient" or significant abnormality of another system (pulmonary, cardiac, renal, and hepatic) which is a contraindication to full dose chemotherapy
6. Unable to give informed consent
Recruitment start date
01/09/2004
Recruitment end date
31/08/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Academic Haematology
Newcastle upon Tyne
NE2 4HH
United Kingdom
Sponsor information
Organisation
Newcastle Hospitals NHS Trust (UK)
Sponsor details
Research & Development
Royal Victoria Infirmary
Newcastle upon Tyne
NE2 4HH
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Marrow & Stem Cell Transplant 2000 (The Millennium Fund) (UK)
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)
Publication list
2012 results in https://www.ncbi.nlm.nih.gov/pubmed/22577177
Publication citations
-
Symposium article
Proctor SJ, Wilkinson J, Extreme Hodgkin's lymphoma: current problem areas., Ann. Oncol., 2006, 17 Suppl 4, iv15-7, doi: 10.1093/annonc/mdj993.