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| A randomised phase III trial of gemcitabine in paclitaxel-containing, epirubicin-based, adjuvant chemotherapy for women with early stage breast cancer |
| Source of record | UK Trials |
| ISRCTN | ISRCTN51146252 |
| Date ISRCTN assigned | 01/07/2001 |
| Local reference number(s) | N/A |
| Public title | A randomised phase III trial of gemcitabine in paclitaxel-containing, epirubicin-based, adjuvant chemotherapy for women with early stage breast cancer |
| Scientific title | |
| Acronym | TANGO |
| Disease/condition/study domain | Breast cancer |
| Study hypothesis | In women with early stage breast cancer, the addition of gemcitabine to paclitaxel-containing, epirubicin-based, adjuvant chemotherapy provides significantly superior disease-free and overall survival, without excess toxicity or prolonged adverse impact on quality of life. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Histological diagnosis of invasive breast carcinoma 2. Completely resected early stage disease 3. Definite indication for adjuvant chemotherapy 4. Any nodal status 5. Any hormone receptor status 6. Fit to receive either of the trial chemotherapy regimens. Adequate bone marrow, hepatic, and renal function. 7. Eastern Cooperative Oncology Group (ECOG) performance status of zero to two 8. Written informed consent 9. No previous chemotherapy or radiotherapy 10. Radiotherapy intent is known (this must be stated at the point of randomisation) 11. Randomisation within eight weeks of surgery, but ideally within one month 12. No previous malignancy except basal cell carcinoma or cervical carcinoma in situ, unless disease-free for ten years, after surgical treatment only 13. Non-pregnant and non-lactating, with no intention of pregnancy during chemotherapy, and prepared to adopt adequate contraceptive measures if pre-menopausal and sexually active 14. No concomitant medical or psychiatric problems that might prevent completion of treatment or follow-up |
| Participants - exclusion criteria | Any of the above criteria not satisfied |
| Patient information material | |
| Anticipated start date | 22/08/2001 |
| Anticipated end date | 26/11/2004 |
| Status of trial | Completed |
| Target number of participants | 3152 |
| Interventions | Control Arm: Epirubicin 90 mg/m^2 (day one) + Cyclophosphamide 600 mg/m^2 (day one); four cycles, three weekly intervals followed by Paclitaxel 175 mg/m^2 (day one); four cycles at three weekly intervals. Research Arm: Epirubicin 90 mg/m^2 (day one) + Cyclophosphamide 600 mg/m^2 (day one); four cycles at three weekly intervals followed by Gemcitabine 1250 mg/m^2 (days one and eight) + Paclitaxel 175 mg/m^2 (day one); four cycles at three weekly intervals. |
| Primary outcome measure(s) | Five year disease-free survival. |
| Secondary outcome measure(s) | Ten year overall survival, toxicity, dose intensity, tolerability & serious adverse events. |
| Sources of funding | Bristol Myers-Squibb Pharmacia and Upjohn Eli Lilly |
| Sponsor name | The University of Birmingham (UK) |
| Sponsor details | Edgbaston Birmingham United Kingdom B15 2TT |
| Sponsor telephone | +44 (0)121 414 7618 |
| Contact name | Mrs Shrushma Loi |
| Contact details | CRUK Clinical Trials Unit Institute for Cancer Studies The University of Birmingham Edgbaston Birmingham United Kingdom B15 2TT |
| Contact telephone | +44 (0)121 414 3789 |
| Contact fax | +44 (0)121 414 3700 |
| Contact email | tango@trials.bham.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN51146252 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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