Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HO3001
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
Cancer drugs
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1990
Overall trial end date
01/04/1996
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/1990
Recruitment end date
01/04/1996
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Cancer Research UK (CRUK) (UK)
Sponsor details
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)207 317 5186
kate.law@cancer.org.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Funder name
British National Lymphoma Investigation (BNLI)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2001 Results in http://www.ncbi.nlm.nih.gov/pubmed/11355937
Publication citations
-
Results
Hancock BW, Gregory WM, Cullen MH, Hudson GV, Burton A, Selby P, Maclennan KA, Jack A, Bessell EM, Smith P, Linch DC, , , ChlVPP alternating with PABlOE is superior to PABlOE alone in the initial treatment of advanced Hodgkin's disease: results of a British National Lymphoma Investigation/Central Lymphoma Group randomized controlled trial., Br. J. Cancer, 2001, 84, 10, 1293-1300, doi: 10.1054/bjoc.2001.1778.