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ISRCTN
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ISRCTN63499520
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ClinicalTrials.gov identifier
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Public title
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Randomised comparison of cyclical anthracyline-based chemotherapy [PA(B1)OE] with alternating chemotherapy [Ch1VPP/PABLOE] in advanced Hodgkin's disease
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Scientific title
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Acronym
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N/A
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Serial number at source
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HO3001
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Study hypothesis
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Lymphoma (Hodgkin's)
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/01/1990
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Anticipated end date
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01/04/1996
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Status of trial
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Completed
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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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.
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Cancer Research UK
British National Lymphoma Investigation (BNLI)
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Trial website
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Publications
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Contact name
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Dr
-
-
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Address
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UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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Tel
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+44 (0) 20 7670 4723
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Fax
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+44 (0) 20 7670 4818
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Email
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register@ctu.mrc.ac.uk
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Sponsor
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Cancer Research UK (CRUK) (UK)
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Address
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PO Box 123
Lincoln's Inn Fields
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City/town
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London
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Zip/Postcode
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WC2A 3PX
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Country
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United Kingdom
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Tel
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+44 (0)20 7317 5186
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Fax
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+44 (0)20 7487 4302
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Email
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kate.law@cancer.org.uk
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Sponsor website:
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http://www.cancer.org.uk
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Date applied
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01/07/2001
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Last edited
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28/05/2008
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Date ISRCTN assigned
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01/07/2001
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