Randomised Comparison of Cyclical Anthracycline-Based Chemotherapy [PA(BI)OE] with Alternating Chemotherapy [ChlVPP/PABIOE] in Advanced Hodgkin's Disease

ISRCTN	ISRCTN46778796
DOI	https://doi.org/10.1186/ISRCTN46778796
Secondary identifying numbers	LY2

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Randomised Comparison of Cyclical Anthracycline-Based Chemotherapy [PA(BI)OE] with Alternating Chemotherapy [ChlVPP/PABIOE] in Advanced Hodgkin's Disease
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	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Cancer drug
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/1990
Completion date	30/04/1996

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	Not provided at time of registration
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/1990
Date of final enrolment	30/04/1996

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

British National Lymphoma Investigation (BNLI) (UK)
Charity

CRC and UCL Cancer Trials Centre
222 Euston Road
London
NW1 2DA
United Kingdom

Research organisation

British National Lymphoma Investigation, Central Lymphoma Group (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

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