A randomised prospective trial of CHOP versus MCOP in elderly patients with intermediate and high grade non-Hodgkins lymphoma

ISRCTN	ISRCTN39268693
DOI	https://doi.org/10.1186/ISRCTN39268693
ClinicalTrials.gov number	NCT00002576
Secondary identifying numbers	NH3003

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr - -
Scientific

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	A randomised prospective trial of CHOP versus MCOP in elderly patients with intermediate and high grade non-Hodgkins lymphoma
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	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 study start date	01/01/1996
Completion date	01/06/2001

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	Not provided at time of registration
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/1996
Date of final enrolment	01/06/2001

MRC Clinical Trials Unit

London
NW1 2DA
United Kingdom

Cancer Research UK (CRUK) (UK)
Charity

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

Charity

Cancer Research UK
Private sector organisation / Other non-profit organizations

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2003	25/01/2019	Yes	No

25/01/2019: Publication reference added