A randomised trial of therapy in advanced Hodgkin's disease
| ISRCTN | ISRCTN97144519 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97144519 |
| ClinicalTrials.gov (NCT) | NCT00003421 |
| Protocol serial number | LY09 |
| Sponsor | Cancer Research UK (CRUK) (UK) |
| Funder | Cancer Research UK (CRUK) (UK) |
- Submission date
- 01/07/2001
- Registration date
- 01/07/2001
- Last edited
- 26/10/2022
- 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
Contact information
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Open label randomised active controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A randomised trial of therapy in advanced Hodgkin's disease |
| Study objectives | To perform an open-label, randomized, controlled trial comparing treatment with doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) with two multidrug regimens (MDRs) for advanced Hodgkin's lymphoma (HL). More details can be found at: http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=97 |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Hodgkin's lymphoma |
| Intervention | Patients with advanced HL (stage III to IV, or earlier stage with systemic symptoms or bulky disease) were randomly assigned between ABVD and MDR specified before randomization as alternating chlorambucil, vinblastine, procarbazine, and prednisolone (ChlVPP) with prednisolone, doxorubicin, bleomycin, vincristine, and etoposide (PABIOE), or hybrid ChlVPP/etoposide, vincristine, and doxorubicin (EVA). Radiotherapy was planned for incomplete response or initial bulk disease. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Doxorubicin, bleomycin, vinblastine, dacarbazine, chlorambucil, vinblastine, procarbazine, prednisolone, vincristine, etoposide |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/01/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 807 |
| Total final enrolment | 807 |
| Key inclusion criteria | 1. Histologically proven Hodgkin's Disease requiring systemic therapy (this may also include patients with Clinical Stage IA or IIA in the presence of adverse factors, eg bulky disease or more than three sites of involvement) 2. Patient fit and able to receive chemotherapy 3. Informed consent |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1998 |
| Date of final enrolment | 01/01/2002 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 20/12/2005 | Yes | No | |
| Results article | results | 10/07/2010 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | 26/10/2022 | No | Yes |
Editorial Notes
25/10/2022: Cancer Research UK plain English results link and total final enrolment added.
