| Source of record | UK Trials |
| ISRCTN | ISRCTN47461840 |
| Date ISRCTN assigned | 01/07/2001 |
| Local reference number(s) | NH3001 |
| Public title | A randomised study comparing weekly alternating chemotherapy with three-weekly chemotherapy in advanced high grade non-Hodgkins lymphoma |
| Scientific title |
|
| Acronym | Not Applicable |
| Disease/condition/study domain | Lymphoma (non-Hodgkins) |
| 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. High grade pathology, malignant lymphoma classified as: Centroblastic; Lymphoblastic; Immunoblastic; True histocytic; High grade unclassified
2. Advanced (stage III or IV, extensive abdominal or otherwise bulky stage II disease)
3. No specific age limit but considered able to tolerate either treatment regimen
4. No previous radiotherapy, chemotherapy or immunotherapy
5. No previous malignancy, except adequately treated basal cell carcinoma or in-situ carcinoma of cervix
6. No serious medical or psychological condition precluding adequate treatment
7. Able to tolerate daily fluid intake of at least 2 litres
8. Ability of participating clinician to support patients with severe marrow hypoplasia |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 1. Regimen CAPOMET: Combination chemotherapy with CAPOMET (cyclophosphamide, adriamycin, prednisolone, vincristine, methotrexate and etoposide). A weekly regimen repeated every 4 weeks with the more myelotoxic combinations cyclophosphamide and adriamycin, methotrexate and etoposide alternating with the more marrow sparing combination prednisolone and vincristine, but ending with cyclophosphamide and adriamycin. Chemotherapy should be continued until complete remission plus 8 weeks with a minimum of 12 weeks of treatment.
2. Regimen CHOP-Methotrexate: Three weekly cycle of combination chemotherapy, CHOP-methotrexate (cyclophosphamide, adriamycin, prednisolone, vincristine and methotrexate) repeated until complete remission plus three cycles for a minimum of five cycles. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Cancer Research UK |
| Sponsor name | Cancer Research UK |
| Sponsor details | PO Box 123
Lincoln's Inn Fields
London
United Kingdom
WC2A 3PX |
| Sponsor telephone | +44 (0)20 7317 5186 |
| Sponsor fax | +44 (0)20 7487 4302 |
| Sponsor email | kate.law@cancer.org.uk |
| Sponsor website | http://www.cancer.org.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 | ISRCTN47461840 |
| Date last extracted from ISRCTN register | 17/04/2008 |
