Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
LY2
Study information
Scientific title
Randomised Comparison of Cyclical Anthracycline-Based Chemotherapy [PA(BI)OE] with Alternating Chemotherapy [ChlVPP/PABIOE] in Advanced Hodgkin's Disease
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
Not specified
Trial type
Not Specified
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
1. PA(BI)OE Regimen: Multi-drug chemotherapy with adriamycin, vincristine, prednisolone, etoposide and bleomycin [PA(BI)OE] cycle repeated every 21 days. A minimum of six courses to be given with at least two following documentation of clinical complete remission and a maximum of eight courses. Bleomycin to be given for the first four courses only.
2. ChlVPP/PABIOE Regimen: Multi-drug chemotherapy with chlorambucil, procarbazine, prednisolone and vinblastine (ChIVPP) alternating every 21 days with PABIOE.
Intervention type
Drug
Phase
Not Specified
Drug names
Cancer drug
Primary outcome measure
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
30/04/1996
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. All previously untreated and properly staged patients aged between 15 and 69 years (inclusive) with Hodgkin's disease for whom chemotherapy is indicated are eligible for this trial, ie Stage I & IIA (poor prognosis), IB, IIB, III, IV
2. Patients must be free from any irreversible medical condition that would drastically limit their life span or prohibit the use of combination chemotherapy. This applies particularly to elderly patients
3. Adequate long term follow-up must be possible
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
30/04/1996
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
British National Lymphoma Investigation (BNLI) (UK)
Sponsor details
CRC and UCL Cancer Trials Centre
222 Euston Road
London
NW1 2DA
United Kingdom
+44 (0)20 7679 8060
bnli@ctc.ucl.ac.uk
Sponsor type
Charity
Website
Funders
Funder type
Research organisation
Funder name
British National Lymphoma Investigation, Central Lymphoma Group (UK)
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
Basic results (scientific)
Publication list