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

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	Trial of CHOP versus CIOP in Good Risk Stage II-IV Patients with Histologically Aggressive Non-Hodgkin's 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	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Cocktail
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/1995
Completion date	14/07/1997

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	Not provided at time of registration
Total final enrolment	211
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/1995
Date of final enrolment	14/07/1997

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

British National Lymphoma Investigation (BNLI) (UK)
Charity

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

Research organisation

British National Lymphoma Investigation

No information available

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

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