Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
09/10/2012
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

Dr - -

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

Protocol/serial number

LY/GR

Study information

Scientific title

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 measures

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

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

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

http://www.bnli.ucl.ac.uk

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes