A randomised study comparing weekly alternating chemotherapy with three-weekly chemotherapy in advanced high grade non-Hodgkins lymphoma

ISRCTN	ISRCTN47461840
DOI	https://doi.org/10.1186/ISRCTN47461840
Protocol serial number	NH3001
Sponsor	Cancer Research UK (CRUK) (UK)
Funder	Cancer Research UK

Submission date: 01/07/2001
Registration date: 01/07/2001
Last edited: 23/02/2015

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

- -
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 randomised study comparing weekly alternating chemotherapy with three-weekly chemotherapy in advanced high grade non-Hodgkins lymphoma
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	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 / device / biological / vaccine name(s)	CAPOMET (cyclophosphamide, adriamycin, prednisolone, vincristine, methotrexate and etoposide), CHOP-methotrexate (cyclophosphamide, adriamycin, prednisolone, vincristine and methotrexate)
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2000

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/2000
Date of final enrolment	31/12/2000

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

MRC Clinical Trials Unit

London
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