Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
30/05/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

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 measures

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

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 Hodgkin’s 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

http://www.bnli.ucl.ac.uk

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes