Condition category
Cancer
Date applied
01/07/2001
Date assigned
01/07/2001
Last edited
10/03/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

- - -

ORCID ID

Contact details

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

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 measures

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

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

http://www.cancer.org.uk

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes