| Source of record | UK Trials |
| ISRCTN | ISRCTN26863825 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | LY/GR |
| Public title | Trial of CHOP versus CIOP in Good Risk Stage II-IV Patients with Histologically Aggressive Non-Hodgkin's Lymphoma |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Lymphoma (non-Hodgkin's) |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/01/1995 |
| Anticipated end date | 14/07/1997 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 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. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | British National Lymphoma Investigation |
| Sponsor name | British National Lymphoma Investigation (BNLI) |
| Sponsor details | CRC and UCL Cancer Trials Centre
222 Euston Road
London
United Kingdom
NW1 2DA |
| Sponsor telephone | +44(0)20 7679 8060 |
| Sponsor fax | +44(0)20 7679 8061 |
| Sponsor email | bnli@ctc.ucl.ac.uk |
| Sponsor website | http://www.bnli.ucl.ac.uk |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN26863825 |
| Date last extracted from ISRCTN register | 17/04/2008 |
