| Source of record | UK Trials |
| ISRCTN | ISRCTN97767916 |
| Date ISRCTN assigned | 01/07/2001 |
| Local reference number(s) | BNLI2 |
| Public title | Randomised trial in newly diagnosed Hodgkin's disease: evaluation of drug scheduling (alternating LOPP/EVAP versus LOPP/EVA hybrid) and consolidation radiotherapy |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Hodgkin's Lymphoma |
| Study hypothesis | Evaluation of drug scheduling (alternating LOPP/EVAP versus LOPP/EVA hybrid) and consolidation radiotherapy |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Aged over 15 years
2. Stage IB, IIB, III or IV Hodgkin's Disease.
3. Histologically confirmed Hodgkin's lymphoma
4. Free from any potentially life threatening disease other than Hodgkin's Disease
5. Lymphangiography or Computed Tomography (CT) scan of the abdomen
6. No previous treatment except as an emergency measure |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | Patients are randomised to either:
1. Regimen A: Chemotherapy, chlorambucil vincristine, procarbazine and prednisolone (LOPP) alternating every 28 days with etoposide, vinblastine, adriamycin and prednisolone (EVAP). A course of chemotherapy is given every 28 days for a minimum of six cycles.
2. Regimen B: Chemotherapy, chlorambucil, vincristine, procarbazine and prednisolone, etoposide, vinblastine, adriamycin (LOPP/EVA) repeated every 28 days for a minimum of six cycles. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | 1. Lymphoma Research Trust
2. Cancer Research UK
3. Lisa Lear Fund
4. Isle of Man Anti-Cancer Association |
| 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 |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN97767916 |
| Date last extracted from ISRCTN register | 17/04/2008 |
