Condition category
Cancer
Date applied
01/07/2001
Date assigned
01/07/2001
Last edited
23/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

- - -

ORCID ID

Contact details

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

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 measures

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

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

http://www.cancer.org.uk

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

Publication citations

Additional files

Editorial Notes