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ISRCTN
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ISRCTN78467637
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ClinicalTrials.gov identifier
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Public title
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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
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Scientific title
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Acronym
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N/A
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Serial number at source
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LY04
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Study hypothesis
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Lymphoma (non-Hodgkin's)
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/01/1995
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Anticipated end date
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16/10/1996
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Status of trial
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Completed
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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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.
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Cancer Research UK
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Trial website
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Publications
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Contact name
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Dr
-
-
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Address
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UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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Tel
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+44 (0) 20 7670 4723
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Fax
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+44 (0) 20 7670 4818
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Email
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register@ctu.mrc.ac.uk
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Sponsor
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Cancer Research UK (CRUK) (UK)
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Address
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PO Box 123
Lincoln's Inn Fields
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City/town
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London
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Zip/Postcode
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WC2A 3PX
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Country
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United Kingdom
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Tel
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+44 (0)20 7317 5186
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Fax
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+44 (0)20 7487 4302
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Email
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kate.law@cancer.org.uk
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Sponsor website:
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http://www.cancer.org.uk
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Date applied
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01/07/2001
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Last edited
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29/05/2008
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Date ISRCTN assigned
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01/07/2001
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