Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NH3001
Study information
Scientific title
A randomised study comparing weekly alternating chemotherapy with three-weekly chemotherapy in advanced high grade non-Hodgkins lymphoma
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
1. Regimen CAPOMET: Combination chemotherapy with CAPOMET (cyclophosphamide, adriamycin, prednisolone, vincristine, methotrexate and etoposide). A weekly regimen repeated every 4 weeks with the more myelotoxic combinations cyclophosphamide and adriamycin, methotrexate and etoposide alternating with the more marrow sparing combination prednisolone and vincristine, but ending with cyclophosphamide and adriamycin. Chemotherapy should be continued until complete remission plus 8 weeks with a minimum of 12 weeks of treatment.
2. Regimen CHOP-Methotrexate: Three weekly cycle of combination chemotherapy, CHOP-methotrexate (cyclophosphamide, adriamycin, prednisolone, vincristine and methotrexate) repeated until complete remission plus three cycles for a minimum of five cycles.
Intervention type
Drug
Phase
Not Applicable
Drug names
CAPOMET (cyclophosphamide, adriamycin, prednisolone, vincristine, methotrexate and etoposide), CHOP-methotrexate (cyclophosphamide, adriamycin, prednisolone, vincristine and methotrexate)
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2000
Overall trial end date
31/12/2000
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. High grade pathology, malignant lymphoma classified as: Centroblastic; Lymphoblastic; Immunoblastic; True histocytic; High grade unclassified
2. Advanced (stage III or IV, extensive abdominal or otherwise bulky stage II disease)
3. No specific age limit but considered able to tolerate either treatment regimen
4. No previous radiotherapy, chemotherapy or immunotherapy
5. No previous malignancy, except adequately treated basal cell carcinoma or in-situ carcinoma of cervix
6. No serious medical or psychological condition precluding adequate treatment
7. Able to tolerate daily fluid intake of at least 2 litres
8. Ability of participating clinician to support patients with severe marrow hypoplasia
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/2000
Recruitment end date
31/12/2000
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 organizations
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
Basic results (scientific)
Publication list