Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ICR/TOPIC
Study information
Scientific title
Acronym
TOPIC I
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
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, ECF (epirubicin, cisplatin and 5-fluorouracil) treatment continuing 3 weekly for six courses
2. AC Regimen: Chemotherapy, AC (adriamycin, cyclophosphamide) treatment continuing 3 weekly for six courses
Intervention type
Drug
Phase
Not Applicable
Drug names
Infusional ECF (Epirubicin, Cisplatin and 5-fluorouracil) versus Conventional AC
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/10/1993
Overall trial end date
01/02/1999
Reason abandoned
Eligibility
Participant inclusion criteria
1. Histologically or cytologically proven breast cancer
2. Aged <70 years
3. Potentially operable primary breast cancer more than 3 cm in diameter
4. Patients assessed as being competent to learn to look after Infumed or Graseby pump
5. World Health Organisation (WHO) performance status 0-1
6. No evidence of metastatic disease
7. Adequate haematological function
8. Glomerular filtration rate of at least 60 ml/min
9. No other serious uncontrolled medical condition
10. No other malignancy, except carcinoma in situ of the cervix or basal cell carcinoma of the skin
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
426 patients from 18 centres, in active follow-up
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/10/1993
Recruitment end date
01/02/1999
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
The Institute of Cancer Research (UK)
Sponsor details
123 Old Brompton Road
London
SW7 3RP
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Research organisation
Funder name
Institute of Cancer Research (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
2004 results in: http://www.ncbi.nlm.nih.gov/pubmed/15111342
Publication citations
-
Results
Smith IE, A'Hern RP, Coombes GA, Howell A, Ebbs SR, Hickish TF, O'Brien ME, Mansi JL, Wilson CB, Robinson AC, Murray PA, Price CG, Perren TJ, Laing RW, Bliss JM, , A novel continuous infusional 5-fluorouracil-based chemotherapy regimen compared with conventional chemotherapy in the neo-adjuvant treatment of early breast cancer: 5 year results of the TOPIC trial., Ann. Oncol., 2004, 15, 5, 751-758.