A randomised trial of therapy in advanced Hodgkin's disease

ISRCTN ISRCTN97144519
DOI https://doi.org/10.1186/ISRCTN97144519
ClinicalTrials.gov number NCT00003421
Secondary identifying numbers LY09
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

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-chemotherapy-hodgkins-lymphoma

Contact information

Dr - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study information

Study designOpen label randomised active controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA randomised trial of therapy in advanced Hodgkin's disease
Study hypothesisTo 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
ConditionHodgkin's lymphoma
InterventionPatients 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Doxorubicin, bleomycin, vinblastine, dacarbazine, chlorambucil, vinblastine, procarbazine, prednisolone, vincristine, etoposide
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/1998
Overall study end date01/01/2002

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants807
Total final enrolment807
Participant inclusion criteria1. 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
Participant exclusion criteriaNot provided at time of registration
Recruitment start date01/01/1998
Recruitment end date01/01/2002

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Cancer Research UK (CRUK) (UK)
Charity

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom

Phone +44 (0)207 317 5186
Email kate.law@cancer.org.uk
Website http://www.cancer.org.uk
ROR logo "ROR" https://ror.org/054225q67

Funders

Funder type

Charity

Cancer Research UK (CRUK) (UK)
Private sector organisation / Other non-profit organizations
Alternative name(s)
CR_UK, Cancer Research UK - London, CRUK
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot 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
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.