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
Secondary identifying numbers NH3001
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

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA randomised study comparing weekly alternating chemotherapy with three-weekly chemotherapy in advanced high grade non-Hodgkins lymphoma
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedLymphoma (non-Hodgkin's)
Intervention1. 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 typeDrug
Pharmaceutical study type(s)
PhaseNot 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 measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/2000
Completion date31/12/2000

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteria1. 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 criteriaNot provided at time of registration
Date of first enrolment01/01/2000
Date of final enrolment31/12/2000

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

Cancer Research UK (CRUK) (UK)
Charity

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

Phone +44 (0)207 317 5186
Email kate.law@cancer.org.uk
Website http://www.cancer.org.uk
ROR logo "ROR" https://ror.org/054225q67

Funders

Funder type

Charity

Cancer Research UK
Private sector organisation / Other non-profit organizations
Alternative name(s)
CR_UK, Cancer Research UK - London, CRUK
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan