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
| ISRCTN | ISRCTN78467637 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78467637 |
| Protocol serial number | LY04 |
| Sponsor | Cancer Research UK (CRUK) (UK) |
| Funder | Cancer Research UK |
- Submission date
- 01/07/2001
- Registration date
- 01/07/2001
- Last edited
- 21/11/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific 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 |
| 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 | 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. |
| Intervention type | Other |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 16/10/1996 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1995 |
| Date of final enrolment | 16/10/1996 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
21/11/2019: No publications found. Verifying results with principal investigator.
