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
Protocol serial number	STANFORD V
Sponsor	British National Lymphoma Investigation (BNLI) (UK)
Funder	British National Lymphoma Investigation (BNLI) (UK)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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
Phase	Phase II
Drug / device / biological / vaccine name(s)	Mustine, doxorubicin, vinblastine, prednisolone, vincristine, bleomycin, etoposide and dacarbazine.
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/06/2008

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	60 Years
Sex	All
Target sample size at registration	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

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	10/11/2009		Yes	No
Other publications	questionnaire-based audit	01/10/2007		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results				No	Yes

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