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ISRCTN
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ISRCTN83324925
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ClinicalTrials.gov identifier
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Public title
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A Randomised Comparative Trial of Infusional ECF versus Conventional FEC as Adjuvant Chemotherapy in Patients with Poor Prognosis Breast Cancer
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Scientific title
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Acronym
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TRAFIC
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Serial number at source
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ICR/TRAFIC
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Study hypothesis
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To compare the relapse-free survival and survival of adjuvant infusional ECF with conventional FEC chemotherapy in patients <50 with node-positive early breast cancer.
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Ethics approval
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Not provided at registration time
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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. Confirmed invasive carcinoma of the breast
2. Treatment to start within 3 months of surgery
3. World Health Organisation (WHO) performance status of zero or one
4. Patients assessed as being competent to learn to look after Infumed or Graseby pump
5. No evidence of metastatic disease (routine Chest X-RAY [CXR], biochemistry)
6. Adequate haematological function
7. A glomerular filtration rate of greater than or equal to 60mls/minute. This can be measured by using an EDTA clearance or 24 hour urinary creatinine clearance at the investigators discretion
8. No other serious uncontrolled medical condition
9. No other malignancy, except carcinoma in situ of the cervix of basal cell carcinoma of the skin
10. Histologically proven invasive breast cancer (excision specimen or Trucut biopsy)
11. Upper age limit 50 years
12. Histologically involved axillary nodes
13. Written informed consent
14. Other investigations, e.g. bone scan, liver ultrasound, are only required for symptoms and/or abnormal biochemistry
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Participants - exclusion criteria
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1. Any patient with a medicinal or psychiatric condition that impairs their ability to cope physically or psychologically with this chemotherapy regimen, or to give informed consent
2. Uncontrolled angina pectoris, heart failure, clinically significant uncontrolled or cardiac arrhythmias
3. Any other serious uncontrolled medical condition
4. Any pregnant or lactating woman
5. Other malignancy (excluding carcinoma in situ of cervix)
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Anticipated start date
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26/06/1995
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Anticipated end date
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30/01/2002
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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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Added 14/07/08: 348 patients
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Interventions
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1. Infusional ECF Regimen: Chemotherapy, infusional ECF (epirubicin, cyclophosphamide, 5-fluorouracil)
2. FEC Regimen: Chemotherapy, conventional FEC (epirubicin, cyclophosphamide, 5-fluorouracil)
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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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Institute of Cancer Research (ICR) (UK)
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Trial website
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Publications
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2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20093351
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Contact name
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Prof
I
Smith
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Address
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Royal Marsden Hospital
Downs Road
Sutton
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City/town
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Surrey
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Zip/Postcode
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SM2 5PT
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Country
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United Kingdom
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Sponsor
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Institute of Cancer Research (ICR) (UK)
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Address
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123 Old Brompton Road
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City/town
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London
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Zip/Postcode
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SW7 3RP
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Country
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United Kingdom
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Sponsor website:
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http://www.icr.ac.uk
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Date applied
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19/08/2002
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Last edited
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25/01/2010
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Date ISRCTN assigned
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19/08/2002
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