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
Secondary identifying numbers	LY04

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

Dr - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/1995
Completion date	16/10/1996

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Not provided at time of registration
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

MRC Clinical Trials Unit

London
NW1 2DA
United Kingdom

Cancer Research UK (CRUK) (UK)
Charity

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom

Charity

Cancer Research UK
Private sector organisation / Other non-profit organizations

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

21/11/2019: No publications found. Verifying results with principal investigator.