Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
LY3
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Lymphoma (non-Hodgkins)
Intervention
Patients were randomised to one of two regimens:
1. CHOP Regimen: Multi-drug chemotherapy with cyclophosphamide, hydroxydaunorubicin, vincristine and prednisolone (CHOP) repeated every 28 days. A minimum of six courses to be given with two courses beyond the attainment of complete response
2. PACEBOM Regimen: Multi-drug chemotherapy with prednisolone, adriamycin, cyclophosphamide and etoposide (PACE) alternating every 7 days with bleomycin, vincristine and methotrexate (BOM). Six cycles of PACE and five of BOM to be given
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/11/1987
Overall trial end date
31/10/1992
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged 16 to 69 years
2. Previously untreated histologically aggressive lymphoma with a large cell component: Diffuse large cell, Diffuse immunoblastic, Diffuse mixed cell
3. Stages II-IV
4. No contraindications to treatment protocols
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Patients with Burkitt's and lymphoblastic lymphoma to be excluded
Recruitment start date
01/11/1987
Recruitment end date
31/10/1992
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
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Funder name
Lymphoma Research Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Lisa Lear Fund
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Isle of Man Anti-Cancer Association
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
1996 results in http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=8688344
Publication citations
-
Results
Linch DC, Vaughan Hudson B, Hancock BW, Hoskin PJ, Cunningham DC, Newland AC, Milligan DW, Stevenson PA, Wood JK, MacLennan KA, Anderson L, Gregory WM, Vaughan Hudson G, A randomised comparison of a third-generation regimen (PACEBOM) with a standard regimen (CHOP) in patients with histologically aggressive non-Hodgkin's lymphoma: a British National Lymphoma Investigation report., Br. J. Cancer, 1996, 74, 2, 318-322.