Plain English Summary
http://cancerhelp.cancerresearchuk.org/trials/a-trial-looking-at-chemotherapy-hodgkins-lymphoma
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00003421
Protocol/serial number
LY09
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Open label randomised active controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
Doxorubicin, bleomycin, vinblastine, dacarbazine, chlorambucil, vinblastine, procarbazine, prednisolone, vincristine, etoposide
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1998
Overall trial end date
01/01/2002
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
807
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/1998
Recruitment end date
01/01/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Cancer Research UK (CRUK) (UK)
Sponsor details
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)207 317 5186
kate.law@cancer.org.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK) (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16314615
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20498402
Publication citations
-
Results
Johnson PW, Radford JA, Cullen MH, Sydes MR, Walewski J, Jack AS, MacLennan KA, Stenning SP, Clawson S, Smith P, Ryder D, Hancock BW, , Comparison of ABVD and alternating or hybrid multidrug regimens for the treatment of advanced Hodgkin's lymphoma: results of the United Kingdom Lymphoma Group LY09 Trial (ISRCTN97144519)., J. Clin. Oncol., 2005, 23, 36, 9208-9218, doi: 10.1200/JCO.2005.03.2151.
-
Results
Johnson PW, Sydes MR, Hancock BW, Cullen M, Radford JA, Stenning SP, Consolidation radiotherapy in patients with advanced Hodgkin's lymphoma: survival data from the UKLG LY09 randomized controlled trial (ISRCTN97144519)., J. Clin. Oncol., 2010, 28, 20, 3352-3359, doi: 10.1200/JCO.2009.26.0323.