Trial of CHOP versus CIOP in Good Risk Stage II-IV Patients with Histologically Aggressive Non-Hodgkin's Lymphoma

ISRCTN ISRCTN26863825
DOI https://doi.org/10.1186/ISRCTN26863825
Secondary identifying numbers LY/GR
Submission date
19/08/2002
Registration date
19/08/2002
Last edited
31/10/2019
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 titleTrial of CHOP versus CIOP in Good Risk Stage II-IV Patients with Histologically Aggressive Non-Hodgkin's 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)
InterventionPatients 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Cocktail
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/1995
Completion date14/07/1997

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Total final enrolment211
Key inclusion criteria1. 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
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/01/1995
Date of final enrolment14/07/1997

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

British National Lymphoma Investigation (BNLI) (UK)
Charity

CRC and UCL Cancer Trials Centre
222 Euston Road
London
NW1 2DA
United Kingdom

Phone +44 (0)20 7679 8060
Email bnli@ctc.ucl.ac.uk
Website http://www.bnli.ucl.ac.uk

Funders

Funder type

Research organisation

British National Lymphoma Investigation

No information available

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 01/08/2005 31/10/2019 Yes No

Editorial Notes

31/10/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.