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 number | NCT00002561 |
| Secondary identifying numbers | HD305 |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 17/05/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| 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 | Not provided at time of registration. |
| Secondary outcome measures | Not provided at time of registration. |
| Overall study start date | 22/07/1994 |
| Completion date | 22/07/1999 |
Eligibility
| 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 |
| 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 |
Locations
Countries of recruitment
- Canada
- England
- United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
National Cancer Institute of Canada Clinical Trials Group (NCIC CTG)
Government
Government
10 Alcorn Avenue
Suite 200
Toronto
M4V 3B1
Canada
| Phone | +1 416 9617223 |
|---|---|
| webadmin@cancer.ca | |
| Website | http://www.ncic.cancer.ca |
Funders
Funder type
Government
National Cancer Institute of Canada Clinical Trials Group
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 02/02/2012 | 17/05/2019 | Yes | No |
Editorial Notes
17/05/2019: Publication reference and total final enrolment added.
