Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
LY04
Study information
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
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1995
Overall trial end date
16/10/1996
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/1995
Recruitment end date
16/10/1996
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Cancer Research UK (CRUK) (UK)
Sponsor details
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)207 317 5186
kate.law@cancer.org.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary