Protocol for a Randomised Phase II Study of the Stanford V regimen compared with ABVD for the treatment of Advanced Hodgkin's Disease

ISRCTN	ISRCTN64141244
DOI	https://doi.org/10.1186/ISRCTN64141244
Secondary identifying numbers	STANFORD V

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Mr Paul Mouncey
Scientific

Lymphoma Trials Office
222 Euston Road
London
NW1 2DA
United Kingdom

Phone	+44 (0) 20 7679 8038
Email	pm@ctc.ucl.ac.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study objectives	To compare the Stanford V regimen with Adriamycin, Bleomycin, Vinblastine, Dacarbazine (ABVD) for the treatment of Advanced Hodgkin's Disease.
Ethics approval(s)	This trial is currently awaiting approval for an amendment, and sites will be able to recruit once this has been granted.
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Phase II
Drug / device / biological / vaccine name(s)	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 study start date	01/01/2001
Completion date	30/06/2008

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	60 Years
Sex	Both
Target number of participants	700
Key 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
Key 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
Date of first enrolment	01/01/2001
Date of final enrolment	30/06/2008

Lymphoma Trials Office

London
NW1 2DA
United Kingdom

British National Lymphoma Investigation (BNLI) (UK)
Charity

CRC and UCL Cancer Trials Centre
222 Euston Road
London
NW1 2DA
United Kingdom

Research organisation

British National Lymphoma Investigation (BNLI) (UK)

No information available

Intention to publish date
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

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Plain English results			No	Yes
Other publications	questionnaire-based audit	01/10/2007	Yes	No
Results article	results	10/11/2009	Yes	No

18/10/2018: Cancer Research UK lay results summary link added to Results (plain English)