A randomised prospective trial of CHOP versus MCOP in elderly patients with intermediate and high grade non-Hodgkins lymphoma
ISRCTN | ISRCTN39268693 |
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DOI | https://doi.org/10.1186/ISRCTN39268693 |
ClinicalTrials.gov number | NCT00002576 |
Secondary identifying numbers | NH3003 |
- Submission date
- 01/07/2001
- Registration date
- 01/07/2001
- Last edited
- 25/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
Study design | Randomised controlled trial |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | A randomised prospective trial of CHOP versus MCOP in elderly patients with intermediate and 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. CHOP Regimen: Combination chemotherapy, CHOP (cyclophosphamide, adriamycin, vincristine, prednisolone) 2. MCOP Regimen: Combination chemotherapy, MCOP (mitozantrone, cyclophosphamide, vincristine, prednisolone) |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Applicable |
Drug / device / biological / vaccine name(s) | CHOP (cyclophosphamide, adriamycin, vincristine, prednisolone), MCOP (mitozantrone, cyclophosphamide, vincristine, prednisolone) |
Primary outcome measure | Not provided at time of registration |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/01/1996 |
Completion date | 01/06/2001 |
Eligibility
Participant type(s) | Patient |
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Age group | Senior |
Sex | Both |
Target number of participants | Not provided at time of registration |
Key inclusion criteria | 1. Histologically confirmed intermediate and high grade non-Hodgkin's lymphoma classified as: Diffuse centroblastic; Diffuse immunoblastic; B and T-cell lymphoblastic; Peripheral T-cell of mixed or large cell type; Ki-l 2. All stages greater than 1a, non bulky 3. Age 65 years and over 4. Considered fit enough to receive either regimen 5. No previous chemotherapy or radiotherapy 6. No previous malignancy, except non-melanoma skin cancer or adequately treated in-situ cervical carcinoma 7. No serious concomitant medical condition that would affect short-term progress 8. No severe ischaemic heart disease or cardiomyopathy which could make treatment with adriamycin undesirable |
Key exclusion criteria | Not provided at time of registration |
Date of first enrolment | 01/01/1996 |
Date of final enrolment | 01/06/2001 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Cancer Research UK (CRUK) (UK)
Charity
Charity
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
Phone | +44 (0)207 317 5186 |
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kate.law@cancer.org.uk | |
Website | http://www.cancer.org.uk |
https://ror.org/054225q67 |
Funders
Funder type
Charity
Cancer Research UK
Private sector organisation / Other non-profit organizations
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 share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 01/02/2003 | 25/01/2019 | Yes | No |
Editorial Notes
25/01/2019: Publication reference added