A Randomised Comparative Trial of Infusional ECF versus Conventional FEC as Adjuvant Chemotherapy in Patients with Poor Prognosis Breast Cancer
| ISRCTN | ISRCTN83324925 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83324925 |
| Secondary identifying numbers | ICR/TRAFIC |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 03/12/2012
- 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
Prof I Smith
Scientific
Scientific
Royal Marsden Hospital
Downs Road
Sutton
Surrey
SM2 5PT
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 | |
| Study acronym | TRAFIC |
| Study objectives | 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(s) | Not provided at registration time |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Infusional ECF versus Conventional FEC |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 26/06/1995 |
| Completion date | 30/01/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | Added 14/07/08: 348 patients |
| Key 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 |
| Key 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) |
| Date of first enrolment | 26/06/1995 |
| Date of final enrolment | 30/01/2002 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Royal Marsden Hospital
Surrey
SM2 5PT
United Kingdom
SM2 5PT
United Kingdom
Sponsor information
Institute of Cancer Research (ICR) (UK)
Research organisation
Research organisation
123 Old Brompton Road
London
SW7 3RP
United Kingdom
| Website | http://www.icr.ac.uk |
|---|---|
"ROR" |
https://ror.org/043jzw605 |
Funders
Funder type
Research organisation
Institute of Cancer Research (ICR) (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Institute of Cancer Research - CIHR, CIHR Institute of Cancer Research, L'Institut du cancer, Institut du cancer, ICR - CIHR, ICR, IC
- Location
- Canada
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 | 01/08/2010 | Yes | No |
