Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
02/09/2014
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

Dr - -

ORCID ID

Contact details

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

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

http://www.icr.ac.uk

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

  1. 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.

Additional files

Editorial Notes