Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00002576
Protocol/serial number
NH3003
Study information
Scientific title
A randomised prospective trial of CHOP versus MCOP in elderly patients with intermediate and high grade non-Hodgkins 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
1. CHOP Regimen: Combination chemotherapy, CHOP (cyclophosphamide, adriamycin, vincristine, prednisolone)
2. MCOP Regimen: Combination chemotherapy, MCOP (mitozantrone, cyclophosphamide, vincristine, prednisolone)
Intervention type
Drug
Phase
Not Applicable
Drug names
CHOP (cyclophosphamide, adriamycin, vincristine, prednisolone), MCOP (mitozantrone, cyclophosphamide, vincristine, prednisolone)
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1996
Overall trial end date
01/06/2001
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Histologically confirmed intermediate and high grade non-Hodgkin's lymphoma classified as: Diffuse centroblastic; Diffuse immunoblastic; B and T-cell lymphoblastic; Peripheral T-cell of mixed or large cell type; Ki-l
2. All stages greater than 1a, non bulky
3. Age 65 years and over
4. Considered fit enough to receive either regimen
5. No previous chemotherapy or radiotherapy 6. No previous malignancy, except non-melanoma skin cancer or adequately treated in-situ cervical carcinoma
7. No serious concomitant medical condition that would affect short-term progress
8. No severe ischaemic heart disease or cardiomyopathy which could make treatment with adriamycin undesirable
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/1996
Recruitment end date
01/06/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Clinical Trials Unit
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)
CRUK
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
Basic results (scientific)
Publication list
1. 2003 results in https://doi.org/10.1093/annonc/mdg067 (added 25/01/2019)