Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ICR/TRAFIC
Study information
Scientific title
Acronym
TRAFIC
Study hypothesis
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.
Ethics approval
Not provided at registration time
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Breast Cancer
Intervention
1. Infusional ECF Regimen: Chemotherapy, infusional ECF (epirubicin, cyclophosphamide, 5-fluorouracil)
2. FEC Regimen: Chemotherapy, conventional FEC (epirubicin, cyclophosphamide, 5-fluorouracil)
Intervention type
Drug
Phase
Phase III
Drug names
Infusional ECF versus Conventional FEC
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
26/06/1995
Overall trial end date
30/01/2002
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Added 14/07/08: 348 patients
Participant exclusion criteria
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)
Recruitment start date
26/06/1995
Recruitment end date
30/01/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Marsden Hospital
Surrey
SM2 5PT
United Kingdom
Sponsor information
Organisation
Institute of Cancer Research (ICR) (UK)
Sponsor details
123 Old Brompton Road
London
SW7 3RP
United Kingdom
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Institute of Cancer Research (ICR) (UK)
Alternative name(s)
Institut du Cancer, l'Institut du cancer, ICR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Canada
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
Basic results (scientific)
Publication list
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20093351
Publication citations
-
Results
Sirohi B, A'Hern R, Coombes G, Bliss JM, Hickish T, Perren T, Crawford M, O'Brien M, Iveson T, Ebbs S, Skene A, Laing R, Smith IE, A randomised comparative trial of infusional ECisF versus conventional FEC as adjuvant chemotherapy in early breast cancer: the TRAFIC trial., Ann. Oncol., 2010, 21, 8, 1623-1629, doi: 10.1093/annonc/mdp602.