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
| ISRCTN | ISRCTN19831176 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19831176 |
| Protocol serial number | ICR/TOPIC |
| Sponsor | The Institute of Cancer Research (UK) |
| Funder | Institute of Cancer Research (UK) |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 02/09/2014
- 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
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | TOPIC I |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Infusional ECF (Epirubicin, Cisplatin and 5-fluorouracil) versus Conventional AC |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/02/1999 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 426 |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/10/1993 |
| Date of final enrolment | 01/02/1999 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2004 | Yes | No |
