Randomised comparison of cyclical anthracyline-based chemotherapy [PA(B1)OE] with alternating chemotherapy [Ch1VPP/PABLOE] in advanced Hodgkin's disease
| ISRCTN | ISRCTN63499520 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63499520 |
| Protocol serial number | HO3001 |
| Sponsor | Cancer Research UK (CRUK) (UK) |
| Funders | Cancer Research UK, British National Lymphoma Investigation (BNLI) |
- Submission date
- 01/07/2001
- Registration date
- 01/07/2001
- Last edited
- 01/02/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Lymphoma (Hodgkin's) |
| Intervention | 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. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Cancer drugs |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/04/1996 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1990 |
| Date of final enrolment | 01/04/1996 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 18/05/2001 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
