| Source of record | UK Trials |
| ISRCTN | ISRCTN64141244 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | STANFORD V |
| Public title | Protocol for a Randomised Phase II Study of the Stanford V regimen compared with ABVD for the treatment of Advanced Hodgkin's Disease |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Lymphoma (Hodgkin's) |
| Study hypothesis | To compare the Stanford V regimen with Adriamycin, Bleomycin, Vinblastine, Dacarbazine (ABVD) for the treatment of Advanced Hodgkin's Disease. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | This trial is currently awaiting approval for an amendment, and sites will be able to recruit once this has been granted. |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - 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 |
| Patient information material |
|
| Anticipated start date | 01/01/2001 |
| Anticipated end date | 30/06/2008 |
| Status of trial | Ongoing |
| Target number of participants | 700 |
| Interventions | STANFORD V regimen: Chemotherapy with mustine, doxorubicin, vinblastine, prednisolone, vincristine, bleomycin and etoposide
ABVD Regimen: Chemotherapy with doxorubicin, bleomycin, vinblastine and dacarbazine |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Publications | Questionnaire-based audit in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=17959922 |
| Sources of funding | British National Lymphoma Investigation (UK) |
| Sponsor name | British National Lymphoma Investigation (BNLI) |
| Sponsor details | CRC and UCL Cancer Trials Centre
222 Euston Road
London
United Kingdom
NW1 2DA |
| Sponsor telephone | +44(0)20 7679 8060 |
| Sponsor fax | +44(0)20 7679 8061 |
| Sponsor email | bnli@ctc.ucl.ac.uk |
| Sponsor website | http://www.bnli.ucl.ac.uk |
| Contact name | Mr Paul Mouncey |
| Contact details | Lymphoma Trials Office
222 Euston Road
London
United Kingdom
NW1 2DA |
| Contact telephone | +44 (0) 20 7679 8038 |
| Contact email | pm@ctc.ucl.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN64141244 |
| Date last extracted from ISRCTN register | 17/04/2008 |
