| Source of record | UK Trials |
| ISRCTN | ISRCTN78467637 |
| Date ISRCTN assigned | 01/07/2001 |
| Local reference number(s) | LY04 |
| Public title | A study to investigate the benefit of adjuvant chemotherapy following resection of localised intermediate grade gastro-intestinal lymphoma and to assess the effect of depth of penetration of the tumour on survival |
| Scientific title |
|
| Acronym | Not Applicable |
| 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. Intermediate and high grade gastrointestinal lymphoma excluding lymphoblastic and Burkitt's lymphoma. All histology will be reviewed by a panel and classified into mucosa-associated lymphoid tissue (MALT) and NON-MALT tumours
2. Complete surgical resection
3. Age 16 years or over
4. No previous chemotherapy or radiotherapy
5. No other previous or concomitant malignant disease except basal cell carcinoma or in situ carcinoma of the cervix
6. No other serious condition contraindicating chemotherapy |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated end date | 16/10/1996 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | Following complete local excision patients are randomised to one of two treatment arms depending on the stage of disease:
STAGE T1-2 N0 M0 PATIENTS:
1. Group A: No further treatment.
2. Group B: Chemotherapy with, cyclophosphamide, hydroxydaunorubicin, vincristine and prednisolone (CHOP) repeated every 21 days for three cycles.
STAGE T3-4 N0-2 M0 PATIENTS:
1. Group C: Chemotherapy with CHOP repeated every 21 days for three cycles.
2. Group D: Chemotherapy with CHOP repeated every 21 days for six 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 | ISRCTN78467637 |
| Date last extracted from ISRCTN register | 17/04/2008 |
