Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
LY/GR
Study information
Scientific title
Trial of CHOP versus CIOP in Good Risk Stage II-IV Patients with Histologically Aggressive Non-Hodgkin's Lymphoma
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
Condition
Lymphoma (non-Hodgkin's)
Intervention
Patients are randomised to one of two treatment regimens:
1. CHOP Regimen: Adriamycin, cyclophosphamide, vincristine and prednisone cycle repeated every 3 weeks. Chemotherapy to be given for two courses beyond complete remission and a minimum of six courses or until progression.
2. CIOP Regimen: Idiarubicin, cyclophosphamide, vincristine and prednisone cycle repeated every 3 weeks. Chemotherapy to be given for two courses beyond complete remission and a minimum of six courses or until progression.
Intervention type
Drug
Phase
Not Specified
Drug names
Cocktail
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1995
Overall trial end date
14/07/1997
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age 16-59 years
2. No medical conditions, other than lymphoma, prohibiting intensive therapy and no systemic treatment for cancer in previous 5 years
3. One of the following histological types:
3.1 Follicular large cell
3.2 Diffuse mixed cell
3.3 Diffuse large cell
3.4 Diffuse immunoblastic lymphomas
4. Full clinical staging to include Computed Tomography (CT) scanning of abdomen and bone marrow trephine biopsy
5. Good prognostic features defined as the presence of less than two of:
5.1 Stage III/IV
5.2 Lactic dehydrogenase (LDH) >normal
5.3 Eastern Cooperative Oncology Group (ECOG) or World Health Organisation (WHO) performance status 2-4
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Total final enrolment
211
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/1995
Recruitment end date
14/07/1997
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
British National Lymphoma Investigation (BNLI) (UK)
Sponsor details
CRC and UCL Cancer Trials Centre
222 Euston Road
London
NW1 2DA
United Kingdom
+44 (0)20 7679 8060
bnli@ctc.ucl.ac.uk
Sponsor type
Charity
Website
Funders
Funder type
Research organisation
Funder name
British National Lymphoma Investigation
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
Basic results (scientific)
Publication list
2005 results in: https://www.ncbi.nlm.nih.gov/pubmed/16098067 (added 31/10/2019)