| Source of record | UK Trials |
| ISRCTN | ISRCTN97144519 |
| Date ISRCTN assigned | 01/07/2001 |
| Local reference number(s) | LY09 |
| Public title | A randomised trial of therapy in advanced Hodgkin's disease |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Hodgkin's lymphoma |
| Study hypothesis | To perform an open-label, randomized, controlled trial comparing treatment with doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) with two multidrug regimens (MDRs) for advanced Hodgkin's lymphoma (HL). |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Histologically proven Hodgkin's Disease requiring systemic therapy (this may also include patients with Clinical Stage IA or IIA in the presence of adverse factors, eg bulky disease or more than three sites of involvement)
2. Patient fit and able to receive chemotherapy
3. Informed consent |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material | Not provided at time of registration |
| Anticipated start date | 01/01/1998 |
| Anticipated end date | 01/01/2002 |
| Status of trial | Completed |
| Target number of participants | 807 |
| Interventions | Patients with advanced HL (stage III to IV, or earlier stage with systemic symptoms or bulky disease) were randomly assigned between ABVD and MDR specified before randomization as alternating chlorambucil, vinblastine, procarbazine, and prednisolone (ChlVPP) with prednisolone, doxorubicin, bleomycin, vincristine, and etoposide (PABIOE), or hybrid ChlVPP/etoposide, vincristine, and doxorubicin (EVA). Radiotherapy was planned for incomplete response or initial bulk disease. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Publications | Results in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16314615 |
| Sources of funding | Cancer Research UK |
| Sponsor name | Cancer Research UK |
| Sponsor details | PO Box 123
Lincoln's Inn Fields
London
United Kingdom
WC2A 3PX |
| Sponsor telephone | +44 (0)20 7317 5186 |
| Sponsor fax | +44 (0)20 7487 4302 |
| Sponsor email | kate.law@cancer.org.uk |
| Sponsor website | http://www.cancer.org.uk |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN97144519 |
| Date last extracted from ISRCTN register | 17/04/2008 |
