| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN83324925 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | ICR/TRAFIC |
| Public title | A Randomised Comparative Trial of Infusional ECF versus Conventional FEC as Adjuvant Chemotherapy in Patients with Poor Prognosis Breast Cancer |
| Scientific title |
|
| Acronym | TRAFIC |
| Disease/condition/study domain | Breast Cancer |
| 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at registration time |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - 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) |
| Patient information material |
|
| Anticipated start date | 26/06/1995 |
| Anticipated end date | 30/01/2002 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 1. Infusional ECF Regimen: Chemotherapy, infusional ECF (epirubicin, cyclophosphamide, 5-fluorouracil)
2. FEC Regimen: Chemotherapy, conventional FEC (epirubicin, cyclophosphamide, 5-fluorouracil) |
| Primary outcome measure(s) | Not provided at registration time |
| Secondary outcome measure(s) | Not provided at registration time |
| Sources of funding | Institute of Cancer Research (ICR) (UK) |
| Sponsor name | The Institute of Cancer Research (UK) |
| Sponsor details | 123 Old Brompton Road
London
United Kingdom
SW7 3RP |
| Sponsor website | http://www.icr.ac.uk |
| Contact name | Prof I Smith |
| Contact details | Royal Marsden Hospital
Downs Road
Sutton
Surrey
United Kingdom
SM2 5PT |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN83324925 |
| Date last extracted from ISRCTN register | 17/04/2008 |
