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ISRCTN
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ISRCTN94798326
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ClinicalTrials.gov identifier
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Public title
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A Phase III Study of Radiotherapy or ABVD Plus Radiotherapy Versus ABVD Alone in the Treatment of Early Stage 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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HD305
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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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Canada
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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. Histologically proven Hodgkin's disease
2. Ann Arbor stage I-IIa disease
3. Age between 16 and 70 years
4. No prior chemotherapy or radiotherapy
5. No prior or concurrent malignancies, except treated basal cell carcinoma
6. No cardiac disease
7. No stage Ia disease which is treatable with involved field only irradiation
8. No interabdominal disease
9. No B symptoms
10. No known Human Immunodeficiency Virus (HIV) infection
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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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22/07/1994
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Anticipated end date
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22/07/1999
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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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Patients are divided into two cohorts based on risk factors and randomised to receive either standard treatment (radiation or combined modality therapy according to cohort assignment) or experimental treatment (ABVD):
1. STANDARD ARM:
A. Cohort 1: Radiotherapy only.
B. Cohort 2: Chemotherapy, adriamycin, bleomycin, vinblastine and decarbazine (ABVD) given intravenously on days 1 and 15 of a 28 day cycle. Two cycles of ABVD to be followed by radiotherapy.
2. EXPERIMENTAL ARM:
Chemotherapy, ABVD given intravenously on days 1 and 15 of a 28 day cycle. Patients initially receive two cycles of ABVD followed by restaging. Patients in complete remission receive a further two cycles of ABVD, and those patients assessed as achieving a partial remission and not demonstrating progressive disease receive a further four cycles of ABVD.
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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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National Cancer Institute of Canada Clinical Trials Group
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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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National Cancer Institute of Canada Clinical Trials Group (NCIC CTG)
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Address
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10 Alcorn Avenue
Suite 200
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City/town
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Toronto
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Zip/Postcode
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M4V 3B1
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Country
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Canada
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Tel
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+1 416 9617223
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Fax
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+1 416 9614189
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Email
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webadmin@cancer.ca
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Sponsor website:
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http://www.ncic.cancer.ca
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Date applied
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19/08/2002
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Last edited
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29/08/2007
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Date ISRCTN assigned
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19/08/2002
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