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
Submission date
01/07/2001
Registration date
01/07/2001
Last edited
25/01/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr - -
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleA randomised prospective trial of CHOP versus MCOP in elderly patients with intermediate and high grade non-Hodgkins lymphoma
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedLymphoma (non-Hodgkin's)
Intervention1. CHOP Regimen: Combination chemotherapy, CHOP (cyclophosphamide, adriamycin, vincristine, prednisolone)
2. MCOP Regimen: Combination chemotherapy, MCOP (mitozantrone, cyclophosphamide, vincristine, prednisolone)
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)CHOP (cyclophosphamide, adriamycin, vincristine, prednisolone), MCOP (mitozantrone, cyclophosphamide, vincristine, prednisolone)
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/1996
Completion date01/06/2001

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participantsNot provided at time of registration
Key inclusion criteria1. 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 criteriaNot provided at time of registration
Date of first enrolment01/01/1996
Date of final enrolment01/06/2001

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

Cancer Research UK (CRUK) (UK)
Charity

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

Phone +44 (0)207 317 5186
Email kate.law@cancer.org.uk
Website http://www.cancer.org.uk
ROR logo "ROR" https://ror.org/054225q67

Funders

Funder type

Charity

Cancer Research UK
Private sector organisation / Other non-profit organizations
Alternative name(s)
CR_UK, Cancer Research UK - London, CRUK
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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

Editorial Notes

25/01/2019: Publication reference added