| Source of record | UK Trials |
| ISRCTN | ISRCTN63499520 |
| Date ISRCTN assigned | 01/07/2001 |
| Local reference number(s) | HO3001 |
| Public title | Randomised comparison of cyclical anthracyline-based chemotherapy [PA(B1)OE] with alternating chemotherapy [Ch1VPP/PABLOE] in advanced Hodgkins disease |
| Scientific title |
|
| Acronym | Not Applicable |
| Disease/condition/study domain | Lymphoma (Hodgkins) |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Previously untreated and properly stage patients with Hodgkin's disease for whom chemotherapy is indicated, ie stage I and IIA (poor prognosis), IB, IIB, III and IV
2. Patients must be free from any irreversible medical condition that would drastically limit their life span or prohibit use of combination chemotherapy
3. Aged 15 to 69 years inclusive |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated end date | 01/04/1996 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | FIRST RANDOMISATION: Patients are randomised to one of two chemotherapy regimens:
1. PA(B1)OE Regimen: Multi-drug chemotherapy with adriamycin, vincristine, prednisolone, etoposide and bleomycin (PA(B1)OE) repeated every 21 days for six to eight courses. Bleomycin is given for the first four course only.
2. Ch1VPP/PABLOE Regimen: Multi-drug chemotherapy with chlorambucil, procarbazine, prednisolone and vinblastine(CH1VPP) alternating with PA(B1)OE. The total cycle Ch1VPP/PA(B1)OE takes 7 weeks. A minimum of six, three each of Ch1VPP and PA(B1)OE, and a maximum of eight courses of chemotherapy to be given.
SECOND RANDOMISATION: Patients in complete remission following chemotherapy whose original presentation was with bulky (>5 cm) nodal disease are eligible for the second randomisation. Patients are randomised to one of two groups:
1. Group A: Radiotherapy 35-40 Gy given over 4 weeks.
2. Group B: No radiotherapy. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Cancer Research UK
British National Lymphoma Investigation (BNLI) |
| 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 | ISRCTN63499520 |
| Date last extracted from ISRCTN register | 17/04/2008 |
