Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
03/12/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof I Smith

ORCID ID

Contact details

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

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 measures

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

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

http://www.icr.ac.uk

Funders

Funder type

Research organisation

Funder name

Institute of Cancer Research (ICR) (UK)

Alternative name(s)

l'Institut du cancer, 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

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20093351

Publication citations

  1. 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.

Additional files

Editorial Notes