Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Mr Paul Mouncey
ORCID ID
Contact details
Lymphoma Trials Office
222 Euston Road
London
NW1 2DA
United Kingdom
+44 (0) 20 7679 8038
pm@ctc.ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
STANFORD V
Study information
Scientific title
Protocol for a Randomised Phase II Study of the Stanford V regimen compared with ABVD for the treatment of Advanced Hodgkin's Disease
Acronym
Study hypothesis
To compare the Stanford V regimen with Adriamycin, Bleomycin, Vinblastine, Dacarbazine (ABVD) for the treatment of Advanced Hodgkin's Disease.
Ethics approval
This trial is currently awaiting approval for an amendment, and sites will be able to recruit once this has been granted.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Lymphoma (Hodgkin's)
Intervention
STANFORD V regimen: Chemotherapy with mustine, doxorubicin, vinblastine, prednisolone, vincristine, bleomycin and etoposide
ABVD Regimen: Chemotherapy with doxorubicin, bleomycin, vinblastine and dacarbazine
Intervention type
Drug
Phase
Phase II
Drug names
Mustine, doxorubicin, vinblastine, prednisolone, vincristine, bleomycin, etoposide and dacarbazine.
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2001
Overall trial end date
30/06/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Histologically confirmed Hodgkin's disease
2. Clinical stage IIB, IIIA, IIIB or IV
3. Aged 18 - 60 years
4. No previous history of malignancy, except for basal cell or squamous cell carcinoma of the skin
5. Normal values for Full Blood Count (FBC), hepatic and renal function, unless directly attributable to involvement by Hodgkin's disease
6. Written informed consent
7. All patients must be assessed by the treating haematologist/medical oncologist and radiation oncologist TOGETHER prior to study entry. This is an absolute requirement for the study eligibility
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
700
Participant exclusion criteria
1. Previous therapy for Hodgkins disease
2. Clinical evidence of infection with the Human Immunodeficiency Virus (HIV)
3. Pre-existing cardiac or pulmonary disease
Recruitment start date
01/01/2001
Recruitment end date
30/06/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Lymphoma Trials Office
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
British National Lymphoma Investigation (BNLI) (UK)
Sponsor details
CRC and UCL Cancer Trials Centre
222 Euston Road
London
NW1 2DA
United Kingdom
+44 (0)20 7679 8060
bnli@ctc.ucl.ac.uk
Sponsor type
Charity
Website
Funders
Funder type
Research organisation
Funder name
British National Lymphoma Investigation (BNLI) (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
1. 2007 questionnaire-based audit in http://www.ncbi.nlm.nih.gov/pubmed/17959922
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19738111
Publication citations
-
Results
Hoskin PJ, Lowry L, Horwich A, Jack A, Mead B, Hancock BW, Smith P, Qian W, Patrick P, Popova B, Pettitt A, Cunningham D, Pettengell R, Sweetenham J, Linch D, Johnson PW, Randomized comparison of the stanford V regimen and ABVD in the treatment of advanced Hodgkin's Lymphoma: United Kingdom National Cancer Research Institute Lymphoma Group Study ISRCTN 64141244., J. Clin. Oncol., 2009, 27, 32, 5390-5396, doi: 10.1200/JCO.2009.23.3239.
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Diez P, Hoskin PJ, Aird EG, Treatment planning and delivery of involved field radiotherapy in advanced Hodgkin's disease: results from a questionnaire-based audit for the UK Stanford V regimen vs ABVD clinical trial quality assurance programme (ISRCTN 64141244)., Br J Radiol, 2007, 80, 958, 816-821, doi: 10.1259/bjr/56458296.