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ISRCTN
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ISRCTN92834934
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ClinicalTrials.gov identifier
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Public title
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A Study Comparing CMF (Cyclophosphamide, Methotrexate, 5-fluorouracil) and MMM (Mitozantrone, Methotrexate, Mitomycin-C) Chemotherapy in Patients with Metastatic Breast Cancer
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Scientific title
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Acronym
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N/A
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Serial number at source
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C90
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Study hypothesis
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Breast cancer
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Participants - inclusion criteria
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1. Histologically proven breast cancer, metastatic or incurable locally recurrent disease
2. No other malignancy except adequately treated in situ carcinoma of cervix or non melanomatous skin cancer
3. Previous adjuvant chemotherapy or neo-adjuvant chemotherapy is acceptable, unless the disease free interval is <2 years following adjuvant CMF chemotherapy
4. Previous chemotherapy for metastatic disease is acceptable
5. Patients must be willing to complete quality of life questionnaire and be interviewed by a senior nurse
6. Normal liver function
7. Patients must be considered fit enough to receive either standard CMF or MMM chemotherapy
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Participants - exclusion criteria
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1. Patients are not eligible if they are eligible for a first line phase II study. Patients may become eligible at the time of progression
2. Patient are not eligible if they present with immediately life threatening disease for whom the physician considers an anthracycline based combination preferable
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Anticipated start date
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01/01/2000
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Anticipated end date
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31/12/2005
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Status of trial
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Completed
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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Patients will be randomised to one of the following:
1. CMF Regimen: Chemotherapy with CMF (cyclophosphamide, methotrexate, 5-fluorouracil), a maximum of six cycles. Folinic acid to be given every 6 h for four doses commencing 24 h after chemotherapy.
2. MMM Regimen: Chemotherapy, MM (mitozantrone, methotrexate) alternating with MMM (mitozantrone, methotrexate, mitomycin-C), a maximum of six cycles in total. Folinic acid to be given every 6 h for four doses commencing 24 h after chemotherapy.
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Cancer Research UK
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Trial website
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Publications
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Contact name
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Dr
-
-
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Address
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UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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Tel
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+44 (0) 20 7670 4723
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Fax
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+44 (0) 20 7670 4818
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Email
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register@ctu.mrc.ac.uk
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Sponsor
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Cancer Research UK (CRUK) (UK)
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Address
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PO Box 123
Lincoln's Inn Fields
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City/town
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London
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Zip/Postcode
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WC2A 3PX
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Country
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United Kingdom
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Tel
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+44 (0)20 7317 5186
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Fax
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+44 (0)20 7487 4302
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Email
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kate.law@cancer.org.uk
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Sponsor website:
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http://www.cancer.org.uk
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Date applied
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19/08/2002
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Last edited
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20/05/2008
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Date ISRCTN assigned
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19/08/2002
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