| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN19831176 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | ICR/TOPIC |
| Public title | A Randomised Comparative Trial of Infusional ECF (Epirubicin, Cisplatin and 5-fluorouracil) versus Conventional AC (Adriamycin, Cyclophosphamide) as Primary (Neoadjuvant) Chemotherapy for Patients with at Least 3cm Diameter Early Breast Cancer |
| Scientific title |
|
| Acronym | TOPIC I |
| Disease/condition/study domain | Breast cancer |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/10/1993 |
| Anticipated end date | 01/02/1999 |
| Status of trial | Completed |
| Target number of participants | 426 patients from 18 centres, in active follow-up |
| Interventions | 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 |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Publications | 2004 results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15111342
|
| Sources of funding | Institute of Cancer Research (UK) |
| Sponsor name | The Institute of Cancer Research (UK) |
| Sponsor details | 123 Old Brompton Road
London
United Kingdom
SW7 3RP |
| Sponsor telephone | +44(0) 20 7352 8133 |
| Sponsor fax | +44(0) 20 7370 5261 |
| Sponsor email | sponsor@unknown.com |
| Sponsor website | http://www.icr.ac.uk |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN19831176 |
| Date last extracted from ISRCTN register | 17/04/2008 |
