Trial of CHOP versus CIOP in Good Risk Stage II-IV Patients with Histologically Aggressive Non-Hodgkin's Lymphoma
ISRCTN | ISRCTN26863825 |
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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
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
Study design | Randomised controlled trial |
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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 |
Eligibility
Participant type(s) | Patient |
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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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
British National Lymphoma Investigation (BNLI) (UK)
Charity
Charity
CRC and UCL Cancer Trials Centre
222 Euston Road
London
NW1 2DA
United Kingdom
Phone | +44 (0)20 7679 8060 |
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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 | |
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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 |
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.