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| Randomised Controlled Trial of CID versus CD for Induction of Remission in Low Grade Non-Hodgkin's Lymphoma and Randomised Controlled Assessment of Interferon as Maintenance Treatment after Remission Induction |
| Source of record | UK Trials |
| ISRCTN | ISRCTN53211392 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | SNLG NHLVIII |
| Public title | Randomised Controlled Trial of CID versus CD for Induction of Remission in Low Grade Non-Hodgkin's Lymphoma and Randomised Controlled Assessment of Interferon as Maintenance Treatment after Remission Induction |
| 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. Kiel classification of low grade non-Hodgkin's lymphoma 2. Stages II to IV 3. Age 15 to 70 years 4. Measurable disease 5. No prior chemotherapy 6. No central nervous system (CNS) involvement 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 8. Adequate bone marrow, renal and hepatic function 9. No medical contraindications to protocol treatments |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material | |
| Anticipated end date | 30/06/2000 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | INDUCTION / CONSOLIDATION: Patients are randomised to one of two treatment arms: 1. Arm A: Chemotherapy with Chlorambucil, idarubicin and dexamethasone (CID), cycle to be repeated every 21 days. Patients showing a response following three courses will receive three further consolidation courses. 2. Arm B: Chemotherapy with Chlorambucil and dexamethasone (CD), cycle to be repeated every 21 days. Patients showing a response following three courses will receive three further consolidation courses. RADIOTHERAPY: Patients may be given localised radiotherapy to initial areas of bulky disease if a complete response in that particular site has not been obtained following induction. MAINTENANCE: Patients who have shown a complete response or good partial response following six cycles of induction therapy are eligible for the second randomisation. Patients are randomised to one of three groups: 1. Group A: No further therapy. 2. Group B: Low dose interferon, 1MU subcutaneously three times a week until progression or maximum of 36 months. 3. Group C: High dose interferon, 3MU subcutaneously three times a week until progression or maximum of 36 months. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Scottish & Newcastle Lymphoma Group |
| Sponsor name | Scotland & Newcastle Lymphoma Group |
| Sponsor details | Medical Statistics Unit, Department of Public Health Sciences University of Edinburgh Medical School Teviot Place Edinburgh United Kingdom EH8 9AG |
| 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 | ISRCTN53211392 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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