A Phase III Study of Radiotherapy or ABVD Plus Radiotherapy Versus ABVD Alone in the Treatment of Early Stage Hodgkin's Disease

ISRCTN	ISRCTN94798326
DOI	https://doi.org/10.1186/ISRCTN94798326
ClinicalTrials.gov (NCT)	NCT00002561
Protocol serial number	HD305
Sponsor	National Cancer Institute of Canada Clinical Trials Group (NCIC CTG)
Funder	National Cancer Institute of Canada Clinical Trials Group

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	A Phase III Study of Radiotherapy or ABVD Plus Radiotherapy Versus ABVD Alone in the Treatment of Early Stage 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	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.
Intervention type	Other
Primary outcome measure(s)	Not provided at time of registration.
Key secondary outcome measure(s)	Not provided at time of registration.
Completion date	22/07/1999

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Total final enrolment	405
Key inclusion criteria	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
Key exclusion criteria	Not provided at time of registration.
Date of first enrolment	22/07/1994
Date of final enrolment	22/07/1999

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	02/02/2012	17/05/2019	Yes	No

17/05/2019: Publication reference and total final enrolment added.