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ISRCTN
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ISRCTN39498786
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ClinicalTrials.gov identifier
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Public title
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A Comparison of Hybrid Chemotherapy versus Hybrid Chemotherapy and Autotransplant in Poor Prognosis 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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SNLG HDIII
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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. Histological diagnosis of Hodgkin's disease
2. Prognostic index of at least 0.5
3. Aged under 60
4. No prior chemotherapy or radiotherapy
5. No known significant heart, lung or renal disease
6. No co-existing malignancies apart from localised skin lesions
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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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01/01/2001
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Anticipated end date
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31/12/2004
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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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All patients receive three, 28 day cycles, of PVACE-BOP (chlorambucil, procarbazine, etoposide, vinblastine, adriamycin, bleomycin and prednisolone), together with co-trimoxazole every 3 weeks for the duration of treatment.
Patients who achieve at least a partial remission are randomised to one of two treatment regimens:
1. Regimen A: Radiotherapy, 30 Gy in 3 weeks to initially bulky sites or residual areas of disease, followed by two further cycles of PVACE-BOP
2. Regimen B: Radiotherapy, 30 Gy in 3 weeks to initially bulky sites or residual areas of disease, followed by intensive chemotherapy with melphan and etoposide plus autologous bone marrow transplantation.
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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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Probable funding from Cancer organisations
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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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UK Co-ordinating Committee for Cancer Research (UKCCCR)
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Address
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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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Date applied
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19/08/2002
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Last edited
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28/04/2008
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Date ISRCTN assigned
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19/08/2002
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