| Source of record | UK Co-ordinating Committee on Cancer Research (UKCCCR) |
| ISRCTN | ISRCTN94798326 |
| Serial number at source | HD305 |
| Title of trial | A Phase III Study of Radiotherapy or ABVD Plus Radiotherapy Versus ABVD Alone in the Treatment of Early Stage Hodgkin's Disease |
| Disease or condition | Lymphoma (Hodgkin's) |
| Current status of trial | Open |
| Objectives | 1. To compare twelve year survival in patients with early stage Hodgkin's disease treated with chemotherapy alone versus standard treatment including radiotherapy
2. To assess freedom and progression at five years |
| Design/methodology | 1. Randomisation stratified by centre 2. Eligible patients are divided into two cohorts based on risk factors. Patients meeting the following criteria are assigned to Cohort 1 all others to Cohort 2: - Lymphocyte predominant or nodular sclerosing histology - Age < 40 years - Erythrocyte sedimentation rate < 50 - Supradiaphragramatic disease or pelvic disease with < four disease sites |
| Eligibility 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 HIV infection |
| Sample size | Current accrual: 401 |
| Randomised interventions | 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 twenty-eight day cycle. Two cycles of ABVD to be followed by radiotherapy.
3. EXPERIMENTAL ARM:
Chemotherapy, ABVD given intravenously on days 1 and 15 of a twenty-eight 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. |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
LONDON NW1 2DA
Tel: +44 (0) 20 7670 4723
Fax: +44 (0) 20 7670 4818
|
| Further information | Further information about this trial may be obtained from UKCCCR Register's own website, which contains full trial reports. |
| General information | Please visit the UKCCCR Register website for further general information. |
| Date live in mRCT | 01 April 2007 |
