Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
NCT00002561
Protocol/serial number
HD305
Study information
Scientific title
A Phase III Study of Radiotherapy or ABVD Plus Radiotherapy Versus ABVD Alone in the Treatment of Early Stage Hodgkin's Disease
Acronym
Study hypothesis
Not provided at time of registration.
Ethics approval(s)
Not provided at time of registration.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Not Specified
Patient information sheet
Condition
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
Not provided at time of registration.
Secondary outcome measures
Not provided at time of registration.
Overall study start date
22/07/1994
Overall study end date
22/07/1999
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Not Specified
Sex
Not Specified
Target number of participants
Not provided at time of registration.
Total final enrolment
405
Participant exclusion criteria
Not provided at time of registration.
Recruitment start date
22/07/1994
Recruitment end date
22/07/1999
Locations
Countries of recruitment
Canada, England, United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
National Cancer Institute of Canada Clinical Trials Group (NCIC CTG)
Sponsor details
10 Alcorn Avenue
Suite 200
Toronto
M4V 3B1
Canada
+1 416 9617223
webadmin@cancer.ca
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
National Cancer Institute of Canada Clinical Trials Group
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 02/02/2012 | 17/05/2019 | Yes | No |