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
Protocol serial number ICR/TRAFIC
Sponsor Institute of Cancer Research (ICR) (UK)
Funder Institute of Cancer Research (ICR) (UK)
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

Royal Marsden Hospital
Downs Road
Sutton
Surrey
SM2 5PT
United Kingdom

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study acronymTRAFIC
Study objectivesTo 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) studiedBreast Cancer
Intervention1. Infusional ECF Regimen: Chemotherapy, infusional ECF (epirubicin, cyclophosphamide, 5-fluorouracil)
2. FEC Regimen: Chemotherapy, conventional FEC (epirubicin, cyclophosphamide, 5-fluorouracil)
Intervention typeDrug
PhasePhase III
Drug / device / biological / vaccine name(s)Infusional ECF versus Conventional FEC
Primary outcome measure(s)

Not provided at time of registration

Key secondary outcome measure(s)

Not provided at time of registration

Completion date30/01/2002

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target sample size at registration348
Key inclusion criteria1. 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 criteria1. 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 enrolment26/06/1995
Date of final enrolment30/01/2002

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Royal Marsden Hospital
Surrey
SM2 5PT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/08/2010 Yes No
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